Burn injuries, trauma, and surgical procedures can give rise to exuberant scarring, which can lead to physical disability and to patients being stigmatized by their disfigurement. In a review article in this week's PLoS Medicine, Geoffrey Gurtner (Department of Surgery, Stanford University School of Medicine) and colleagues examine the process of such hypertrophic scar formation, the results of current treatments, and the research areas that are likely to lead to advances in the field.
Annually, over 1 million people require treatment for burns in the United States, 2 million are injured in motor vehicle accidents, and over 34 million related surgical procedures are performed. Although the incidence of hypertrophic scarring following these types of injuries is not known, say the authors, "it is a common outcome that creates a problem of enormous magnitude. Treatment of these cases is estimated to cost at least $4 billion per annum in the US alone." And the incidence of burns and traumatic injuries is even greater in the developing world.
Citation: Aarabi S, Longaker MT, Gurtner GC (2007)
Hypertrophic scar formation following burns and trauma: New approaches to treatment. PLoS Med 4(9): e234.
Click here for access to the published paper
CONTACT:
Geoffrey Gurtner
Stanford University School of Medicine
257 Campus Drive West
Mayer Building #GK210
Stanford, CA 94305
United States of America
About PLoS Medicine
PLoS Medicine is an open access, freely available international medical journal. It publishes original research that enhances our understanding of human health and disease, together with commentary and analysis of important global health issues. For more information, visit plosmedicine/
About the Public Library of Science
The Public Library of Science (PLoS) is a non-profit organization of scientists and physicians committed to making the world's scientific and medical literature a freely available public resource. For more information, visit plos/
четверг, 23 июня 2011 г.
среда, 22 июня 2011 г.
Steroids Are Abused For Skin, Not Just Muscles
Steroids have been in the
press lately and given a bad name for abuse. There must be reasons why
people use steroid products on a regular basis and don't know it. Our skin
is the largest organ of the human body, and it needs to stay healthy. Most
dermatologists treat the 15 million chronic skin patients in the US with
steroids, without the patient ever knowing.
Consistent steroid use for skin problems can result in thinning of the
skin, allergies, resistance to steroid therapy and even Cushing's disease
(a consistent redness caused by capillary blockage).
Seagate Medical has launched a new natural skin care drug called epizyn
(epizyn) that consists primarily of zinc gluconate. It is a
unique patented broad spectrum gel and spray topical that penetrates skin
on a cellular level to help relieve chronic skin conditions such as
pruritis (itchy skin), burns, redness, acne, rashes (especially diaper
rash), dry skin, psoriasis, and eczema (atopic dermatitis). It is a natural
healing agent that is also great for wounds and greatly reducing scarring.
It can even be used around the eyes.
"Epizyn is the greatest thing I have ever used," said Bill Smith of
Fayette, MO.
Unlike other zinc skin treatments, including zinc pyrithione and zinc
oxide, epizyn offers greater bio-availability and pharmacokinetic
properties, offering increased systemic circulation to rapidly assist in
the body's natural capability to restore skin back to its natural state.
Most do not know that 20% of zinc in the human body is contained in the
skin.
Originally, the epizyn compound was successfully used for treating skin
conditions on numerous animal species including lacerations and even
serious snake bites on horses. Those treating the animals could not believe
the amazing effects it had on their own skin and word got out to
dermatologists that the compound worked to heal the animal owners' skin
conditions just as well. Now it is the fastest-growing natural skin care
product on the market. Sold through dermatologists and the Internet, epizyn
is the only non-steroidal zinc gluconate available on the market.
About Seagate Medical, Inc.
Seagate Medical was founded on the principal of developing natural
treatments with high efficacy and low cost. (In fact they offer discounts
to their clients for future orders and huge breaks to practicing
physicians.) "Our mission is to provide medical products to treat chronic
conditions without fear of side effects," said Maureen Kelley, a licensed
esthetician who is employed by Seagate Medical.
Seagate Medical, Inc.
epizyn
press lately and given a bad name for abuse. There must be reasons why
people use steroid products on a regular basis and don't know it. Our skin
is the largest organ of the human body, and it needs to stay healthy. Most
dermatologists treat the 15 million chronic skin patients in the US with
steroids, without the patient ever knowing.
Consistent steroid use for skin problems can result in thinning of the
skin, allergies, resistance to steroid therapy and even Cushing's disease
(a consistent redness caused by capillary blockage).
Seagate Medical has launched a new natural skin care drug called epizyn
(epizyn) that consists primarily of zinc gluconate. It is a
unique patented broad spectrum gel and spray topical that penetrates skin
on a cellular level to help relieve chronic skin conditions such as
pruritis (itchy skin), burns, redness, acne, rashes (especially diaper
rash), dry skin, psoriasis, and eczema (atopic dermatitis). It is a natural
healing agent that is also great for wounds and greatly reducing scarring.
It can even be used around the eyes.
"Epizyn is the greatest thing I have ever used," said Bill Smith of
Fayette, MO.
Unlike other zinc skin treatments, including zinc pyrithione and zinc
oxide, epizyn offers greater bio-availability and pharmacokinetic
properties, offering increased systemic circulation to rapidly assist in
the body's natural capability to restore skin back to its natural state.
Most do not know that 20% of zinc in the human body is contained in the
skin.
Originally, the epizyn compound was successfully used for treating skin
conditions on numerous animal species including lacerations and even
serious snake bites on horses. Those treating the animals could not believe
the amazing effects it had on their own skin and word got out to
dermatologists that the compound worked to heal the animal owners' skin
conditions just as well. Now it is the fastest-growing natural skin care
product on the market. Sold through dermatologists and the Internet, epizyn
is the only non-steroidal zinc gluconate available on the market.
About Seagate Medical, Inc.
Seagate Medical was founded on the principal of developing natural
treatments with high efficacy and low cost. (In fact they offer discounts
to their clients for future orders and huge breaks to practicing
physicians.) "Our mission is to provide medical products to treat chronic
conditions without fear of side effects," said Maureen Kelley, a licensed
esthetician who is employed by Seagate Medical.
Seagate Medical, Inc.
epizyn
вторник, 21 июня 2011 г.
Senetek PLC Announces Positive Results From Pyratine-6(TM) Clinical Trial In Patients With Acne Rosacea
Senetek PLC (OTC Bulletin
Board: SNKTY), a Life Sciences company engaged in the development of
technologies that target the science of healthy aging, announced
positive study results from a clinical trial of Pyratine-6(TM) in patients
with acne rosacea. The findings have been accepted for presentation at the
International Investigative Congress of Dermatology at its May 2008 meeting
in Kyoto, Japan.
Based on positive results demonstrated in previous studies of
Pyratine-6(TM) (0.1%), for the remediation of photodamaged skin and
erythema which included unprecedented reduction in facial redness, in as
early as two weeks, an additional study was initiated for acne rosacea. The
follow up study was designed to extend these significant clinical findings
by assessing the effects of Pyratine-6(TM) (0.125%) in improving clinical
signs and symptoms of acne rosacea. Twenty-four subjects with
mild-to-moderate acne rosacea participated in the 12 week study. Subjects
were evaluated at baseline, 4, 8 and 12 weeks. Evaluations included
physician assessments of inflammatory lesion count, severity of erythema
and telangiectasia, and overall clinical improvement. Patient assessments
of signs and symptoms of rosacea and skin tolerance were also rated at each
follow-up. In addition, transepidermal water loss measurements and facial
photography were conducted at each visit.
Pyratine-6(TM) produced a progressive decrease in the symptoms
associated with rosacea including redness and acne lesions. All subject
self-assessments showed good tolerability and cosmetic acceptability. After
12 weeks there was overall clinical improvement in 80% of subjects,
including reduction of erythema and papules. Transepidermal water loss
measurements showed a 22% decrease in water loss, which supports an
improvement in skin barrier function. In view of the promising results, the
current study has been extended to 48 weeks.
Rosacea is a common chronic facial dermatosis, affecting 14 million
Americans, that is characterized by persistent erythema, telangiectasia,
papules and pustules. Patients with rosacea are often unable to tolerate
extended treatment periods with topical agents as a result of skin
sensitivity that accompanies rosacea. Due to the chronic nature of rosacea,
there is a continuing need for efficacious treatments that provide
sustained relief of its principal signs and symptoms.
Dr. Arisa Ortiz from the University of California Irvine, who is
presenting the results of this study at the 2008 International
Investigative Dermatology meeting in Kyoto, Japan, stated, "All study
subjects reported good tolerability and cosmetic acceptability to
Pyratine-6 (TM). The majority of subjects showed reductions in erythema,
papules, burning, stinging, and dryness, all of which are signs and
symptoms associated with acne rosacea. Transepidermal water loss
measurements showed a decrease in water loss which supports an improvement
in skin barrier function, attesting to the moisturizing properties of this
compound."
Commenting on these findings, Frank Massino, Senetek Chairman and Chief
Executive Officer stated, "We are pleased by the positive study findings as
this further confirms the excellent safety and effectiveness profile of
Pyratine-6(TM). Response to Pyratine-6(TM) in the U.S. physician market has
been outstanding and we look forward to expanding our sales and marketing
efforts to accommodate increasing demand for this important product."
About Senetek PLC
Senetek PLC (OTCBB: SNKTY) is a Life Sciences company engaged in the
development of breakthrough technologies that target the science of healthy
aging. The Company's extensive research collaborations have resulted in a
strong pipeline of patented compounds and products with broad therapeutic
applications and a leading presence in dermatology. Senetek collaborates
with established specialty pharmaceutical companies in the final
development and marketing of its proprietary products, most recently
resulting in the development of the best-selling anti-aging product sold in
the North American physician market.
For more information, visit the company's website at
senetekplc.
This news release contains statements that may be considered
'forward-looking statements' within the meaning of the Private Securities
Litigation Reform Act. Forward-looking statements by their nature involve
substantial uncertainty, and actual results may differ materially from
those that might be suggested by such statements. Important factors
identified by the Company that it believes could result in such material
differences are described in the Company's Annual Report on Form 10-K for
the year 2007. However, the Company necessarily can give no assurance that
it has identified or will identify all of the factors that may result in
any particular forward-looking statement materially differing from actual
results, and the Company assumes no obligation to correct or update any
forward-looking statements which may prove to be inaccurate, whether as a
result of new information, future events or otherwise.
Senetek, PLC
senetekplc
Board: SNKTY), a Life Sciences company engaged in the development of
technologies that target the science of healthy aging, announced
positive study results from a clinical trial of Pyratine-6(TM) in patients
with acne rosacea. The findings have been accepted for presentation at the
International Investigative Congress of Dermatology at its May 2008 meeting
in Kyoto, Japan.
Based on positive results demonstrated in previous studies of
Pyratine-6(TM) (0.1%), for the remediation of photodamaged skin and
erythema which included unprecedented reduction in facial redness, in as
early as two weeks, an additional study was initiated for acne rosacea. The
follow up study was designed to extend these significant clinical findings
by assessing the effects of Pyratine-6(TM) (0.125%) in improving clinical
signs and symptoms of acne rosacea. Twenty-four subjects with
mild-to-moderate acne rosacea participated in the 12 week study. Subjects
were evaluated at baseline, 4, 8 and 12 weeks. Evaluations included
physician assessments of inflammatory lesion count, severity of erythema
and telangiectasia, and overall clinical improvement. Patient assessments
of signs and symptoms of rosacea and skin tolerance were also rated at each
follow-up. In addition, transepidermal water loss measurements and facial
photography were conducted at each visit.
Pyratine-6(TM) produced a progressive decrease in the symptoms
associated with rosacea including redness and acne lesions. All subject
self-assessments showed good tolerability and cosmetic acceptability. After
12 weeks there was overall clinical improvement in 80% of subjects,
including reduction of erythema and papules. Transepidermal water loss
measurements showed a 22% decrease in water loss, which supports an
improvement in skin barrier function. In view of the promising results, the
current study has been extended to 48 weeks.
Rosacea is a common chronic facial dermatosis, affecting 14 million
Americans, that is characterized by persistent erythema, telangiectasia,
papules and pustules. Patients with rosacea are often unable to tolerate
extended treatment periods with topical agents as a result of skin
sensitivity that accompanies rosacea. Due to the chronic nature of rosacea,
there is a continuing need for efficacious treatments that provide
sustained relief of its principal signs and symptoms.
Dr. Arisa Ortiz from the University of California Irvine, who is
presenting the results of this study at the 2008 International
Investigative Dermatology meeting in Kyoto, Japan, stated, "All study
subjects reported good tolerability and cosmetic acceptability to
Pyratine-6 (TM). The majority of subjects showed reductions in erythema,
papules, burning, stinging, and dryness, all of which are signs and
symptoms associated with acne rosacea. Transepidermal water loss
measurements showed a decrease in water loss which supports an improvement
in skin barrier function, attesting to the moisturizing properties of this
compound."
Commenting on these findings, Frank Massino, Senetek Chairman and Chief
Executive Officer stated, "We are pleased by the positive study findings as
this further confirms the excellent safety and effectiveness profile of
Pyratine-6(TM). Response to Pyratine-6(TM) in the U.S. physician market has
been outstanding and we look forward to expanding our sales and marketing
efforts to accommodate increasing demand for this important product."
About Senetek PLC
Senetek PLC (OTCBB: SNKTY) is a Life Sciences company engaged in the
development of breakthrough technologies that target the science of healthy
aging. The Company's extensive research collaborations have resulted in a
strong pipeline of patented compounds and products with broad therapeutic
applications and a leading presence in dermatology. Senetek collaborates
with established specialty pharmaceutical companies in the final
development and marketing of its proprietary products, most recently
resulting in the development of the best-selling anti-aging product sold in
the North American physician market.
For more information, visit the company's website at
senetekplc.
This news release contains statements that may be considered
'forward-looking statements' within the meaning of the Private Securities
Litigation Reform Act. Forward-looking statements by their nature involve
substantial uncertainty, and actual results may differ materially from
those that might be suggested by such statements. Important factors
identified by the Company that it believes could result in such material
differences are described in the Company's Annual Report on Form 10-K for
the year 2007. However, the Company necessarily can give no assurance that
it has identified or will identify all of the factors that may result in
any particular forward-looking statement materially differing from actual
results, and the Company assumes no obligation to correct or update any
forward-looking statements which may prove to be inaccurate, whether as a
result of new information, future events or otherwise.
Senetek, PLC
senetekplc
понедельник, 20 июня 2011 г.
People Are Concerned About Skin Cancer Yet They May Not Understand The Risks Of Sun Exposure Or Indoor Tanning
When it comes to tanning, dermatologists have long suspected that most people need an attitude adjustment. Now, results of a new survey by the American Academy of Dermatology (Academy) confirmed that the majority of people still idolize the bronzed look of a tan despite wanting to protect themselves from skin cancer.
The "Suntelligence: How Sun Smart is Your City?" online survey polled more than 7,000 adults nationwide to determine their knowledge, attitudes and behaviors toward tanning, sun protection and skin cancer detection. Twenty-six cities were ranked based on respondents' answers to several questions in each category.
"Our survey highlighted the contradictory feelings that many people have about tanning - they like the way a tan looks but are concerned about skin cancer, which is estimated to affect about one in five Americans in their lifetime," said dermatologist Zoe D. Draelos, MD, FAAD, consulting professor at Duke University School of Medicine, Durham, N.C. "What they may not realize is that no matter whether you tan or burn, a tan from the sun or tanning beds damages the skin and can cause wrinkles, age spots and skin cancer. The challenge is changing the long-standing attitudes about tanning to correlate with people's knowledge about skin cancer."
In examining the survey data, Dr. Draelos noted that 72 percent of all respondents agreed that people look more attractive with a tan. In addition, more men than women (76 percent vs. 68 percent, respectively) agreed with that statement.
Similarly, 66 percent of all respondents agreed that people look healthier with a tan. Once again more men than women (70 percent vs. 62 percent, respectively) agreed with this statement.
When asked whether or not they believed that sun exposure is good for your health, 60 percent of all respondents mistakenly agreed with this statement. Analyzing the data by gender, more men than women (62 percent vs. 58 percent, respectively) incorrectly thought that sun exposure is good for your health.
"Various reports touting the potential health benefits of sun exposure for vitamin D production are misleading people to believe that exposing oneself to UV radiation - which causes cancer - to prevent another disease is somehow beneficial," said Dr. Draelos. "In fact, the Academy does not recommend getting vitamin D from any form of UV exposure because UV radiation from the sun and tanning beds can lead to the development of skin cancer. Getting vitamin D from a healthy diet, which includes naturally enriched vitamin D foods, fortified foods and beverages, and/or vitamin supplements is a healthier alternative because it provides the exact same benefit without the skin cancer risk."
Dr. Draelos added that despite their positive attitudes about tanning, the majority of respondents expressed strong opinions on protecting themselves from skin cancer. For example, 75 percent of all respondents said they will do anything possible to prevent skin cancer. Furthermore, 80 percent of respondents expressed concern about skin cancer and feel it is important to protect themselves.
"When it comes to preventing skin cancer, actions speak louder than words," said Dr. Draelos. "So while it is encouraging that most people are concerned about skin cancer and want to reduce their risk of developing it, clearly more work needs to be done to change attitudes on tanning. If a person likes the look of a tan, he or she should consider using a self-tanner but use sunscreen with it."
May is Melanoma/Skin Cancer Detection and Prevention Month®. Visit melanomamonday to take the Academy's "Suntelligence" survey, as well as to find out how to perform a skin self-exam, download a body mole map or find free skin cancer screenings in your area.
The "Suntelligence" survey was conducted for the Academy by RH Research of Chicago from January 12 to January 31, 2010. A total of 7,116 respondents completed the online survey; more than 200 completes were conducted in each of the 26 selected MSAs (metropolitan statistical area) and an additional 1,123 completes were conducted in the U.S. outside of the MSAs. The survey's margin of error was ?±1.2 percent for national data and ?±6.9 percent for results stratified by MSA.
Source
American Academy of Dermatology (AAD)
The "Suntelligence: How Sun Smart is Your City?" online survey polled more than 7,000 adults nationwide to determine their knowledge, attitudes and behaviors toward tanning, sun protection and skin cancer detection. Twenty-six cities were ranked based on respondents' answers to several questions in each category.
"Our survey highlighted the contradictory feelings that many people have about tanning - they like the way a tan looks but are concerned about skin cancer, which is estimated to affect about one in five Americans in their lifetime," said dermatologist Zoe D. Draelos, MD, FAAD, consulting professor at Duke University School of Medicine, Durham, N.C. "What they may not realize is that no matter whether you tan or burn, a tan from the sun or tanning beds damages the skin and can cause wrinkles, age spots and skin cancer. The challenge is changing the long-standing attitudes about tanning to correlate with people's knowledge about skin cancer."
In examining the survey data, Dr. Draelos noted that 72 percent of all respondents agreed that people look more attractive with a tan. In addition, more men than women (76 percent vs. 68 percent, respectively) agreed with that statement.
Similarly, 66 percent of all respondents agreed that people look healthier with a tan. Once again more men than women (70 percent vs. 62 percent, respectively) agreed with this statement.
When asked whether or not they believed that sun exposure is good for your health, 60 percent of all respondents mistakenly agreed with this statement. Analyzing the data by gender, more men than women (62 percent vs. 58 percent, respectively) incorrectly thought that sun exposure is good for your health.
"Various reports touting the potential health benefits of sun exposure for vitamin D production are misleading people to believe that exposing oneself to UV radiation - which causes cancer - to prevent another disease is somehow beneficial," said Dr. Draelos. "In fact, the Academy does not recommend getting vitamin D from any form of UV exposure because UV radiation from the sun and tanning beds can lead to the development of skin cancer. Getting vitamin D from a healthy diet, which includes naturally enriched vitamin D foods, fortified foods and beverages, and/or vitamin supplements is a healthier alternative because it provides the exact same benefit without the skin cancer risk."
Dr. Draelos added that despite their positive attitudes about tanning, the majority of respondents expressed strong opinions on protecting themselves from skin cancer. For example, 75 percent of all respondents said they will do anything possible to prevent skin cancer. Furthermore, 80 percent of respondents expressed concern about skin cancer and feel it is important to protect themselves.
"When it comes to preventing skin cancer, actions speak louder than words," said Dr. Draelos. "So while it is encouraging that most people are concerned about skin cancer and want to reduce their risk of developing it, clearly more work needs to be done to change attitudes on tanning. If a person likes the look of a tan, he or she should consider using a self-tanner but use sunscreen with it."
May is Melanoma/Skin Cancer Detection and Prevention Month®. Visit melanomamonday to take the Academy's "Suntelligence" survey, as well as to find out how to perform a skin self-exam, download a body mole map or find free skin cancer screenings in your area.
The "Suntelligence" survey was conducted for the Academy by RH Research of Chicago from January 12 to January 31, 2010. A total of 7,116 respondents completed the online survey; more than 200 completes were conducted in each of the 26 selected MSAs (metropolitan statistical area) and an additional 1,123 completes were conducted in the U.S. outside of the MSAs. The survey's margin of error was ?±1.2 percent for national data and ?±6.9 percent for results stratified by MSA.
Source
American Academy of Dermatology (AAD)
воскресенье, 19 июня 2011 г.
Promising Results In Treating Facial Bruising From Injectables
Physicians nationwide report
promising results in treating facial bruising from injectable cosmetic
treatments by using Pinoxide(TM), an active ingredient best known for
treating under-eye circles.
Pinoxide is a proprietary blend of bicyclic monoterpene dials (BMTd)
created by AGI Dermatics and formulated in the company's Remergent
Microcirculation Therapy product. Pinoxide has been clinically proven to
speed blood flow, warm the skin, increase resistance to cold, and reduce
dark under- eye symptoms. Additional research suggests Pinoxide may also
contribute to promoting firmness and resiliency in the skin. Now,
physicians are studying the ingredient's ability to heal bruising.
Dr. Mark G. Rubin, a board-certified dermatologist currently practicing
at the Lasky Clinic in Beverly Hills, is conducting the clinical trials on
Pinoxide, applying the Microcirculation Therapy formula to the injection
site immediately after use of skin fillers such as collagen, Restylane and
Juvederm, or Botox.
"Anatomically speaking, dark circles are like bruises - so the science
behind using Pinoxide for bruising makes total sense," said Dr. Rubin. "The
skin discoloration during bruising is the result of blood leaking from
damaged blood vessels and surfacing to the skin. Similarly, blood vessels
under the eyes can burst, leading to the appearance of unattractive dark
circles."
Leading dermatologists share Dr. Rubin's opinion. Dr. Thomas Francel, a
board certified plastic surgeon, has found that application of
MicroCirculation Therapy on his patients reduces the appearance of skin
bruising, and decreases the amount of healing time for the bruise. Dr.
Francel is the Chief of Plastic Surgery at St. John's Mercy Medical Center
and an Associate Professor of Surgery at St. Louis University.
Injectable cosmetic treatments are among the five top most requested
aesthetic treatments nationwide last year. According to the American
Society for Aesthetic Plastic Surgery, more than 5 million women had
injectable cosmetic treatments last year. Bruising is a common temporary
side effect.
AGI Dermatics is the bio pharmaceutical laboratory that has led the
research of DNA repair of the skin for more than 20 years. Founded by
Daniel B. Yarosh, PhD, AGI Dermatics specializes in skin photobiology,
dedicating research and development to DNA repair, solar impact on the
immune system, and cell-signaling in skin. The company's application of
groundbreaking active ingredients and meticulously engineered liposome
delivery systems is validated in controlled clinical studies and published
in dozens of peer-reviewed scientific and medical journals. agiderm
AGI Dermatics
agiderm
View drug information on Botox Cosmetic.
promising results in treating facial bruising from injectable cosmetic
treatments by using Pinoxide(TM), an active ingredient best known for
treating under-eye circles.
Pinoxide is a proprietary blend of bicyclic monoterpene dials (BMTd)
created by AGI Dermatics and formulated in the company's Remergent
Microcirculation Therapy product. Pinoxide has been clinically proven to
speed blood flow, warm the skin, increase resistance to cold, and reduce
dark under- eye symptoms. Additional research suggests Pinoxide may also
contribute to promoting firmness and resiliency in the skin. Now,
physicians are studying the ingredient's ability to heal bruising.
Dr. Mark G. Rubin, a board-certified dermatologist currently practicing
at the Lasky Clinic in Beverly Hills, is conducting the clinical trials on
Pinoxide, applying the Microcirculation Therapy formula to the injection
site immediately after use of skin fillers such as collagen, Restylane and
Juvederm, or Botox.
"Anatomically speaking, dark circles are like bruises - so the science
behind using Pinoxide for bruising makes total sense," said Dr. Rubin. "The
skin discoloration during bruising is the result of blood leaking from
damaged blood vessels and surfacing to the skin. Similarly, blood vessels
under the eyes can burst, leading to the appearance of unattractive dark
circles."
Leading dermatologists share Dr. Rubin's opinion. Dr. Thomas Francel, a
board certified plastic surgeon, has found that application of
MicroCirculation Therapy on his patients reduces the appearance of skin
bruising, and decreases the amount of healing time for the bruise. Dr.
Francel is the Chief of Plastic Surgery at St. John's Mercy Medical Center
and an Associate Professor of Surgery at St. Louis University.
Injectable cosmetic treatments are among the five top most requested
aesthetic treatments nationwide last year. According to the American
Society for Aesthetic Plastic Surgery, more than 5 million women had
injectable cosmetic treatments last year. Bruising is a common temporary
side effect.
AGI Dermatics is the bio pharmaceutical laboratory that has led the
research of DNA repair of the skin for more than 20 years. Founded by
Daniel B. Yarosh, PhD, AGI Dermatics specializes in skin photobiology,
dedicating research and development to DNA repair, solar impact on the
immune system, and cell-signaling in skin. The company's application of
groundbreaking active ingredients and meticulously engineered liposome
delivery systems is validated in controlled clinical studies and published
in dozens of peer-reviewed scientific and medical journals. agiderm
AGI Dermatics
agiderm
View drug information on Botox Cosmetic.
суббота, 18 июня 2011 г.
Honey Helps Problem Wounds
A household remedy millennia old is being reinstated: honey helps the treatment of some wounds better than the most modern antibiotics. For several years now medical experts from the University of Bonn have been clocking up largely positive experience with what is known as medihoney. Even chronic wounds infected with multi-resistant bacteria often healed within a few weeks. In conjunction with colleagues from D?sseldorf, Homburg and Berlin they now want to test the experience gained in a large-scale study, as objective data on the curative properties of honey are thin on the ground.
The fact that honey can help wounds to heal is something that was known to the Ancient Egyptians several thousand years ago. And in the last two world wars poultices with honey were used to assist the healing process in soldiers' wounds. However, the rise of the new antibiotics replaced this household remedy. 'In hospitals today we are faced with germs which are resistant to almost all the current anti-biotics,' Dr. Arne Simon explains. 'As a result, the medical use of honey is becoming attractive again for the treatment of wounds.'
Dr. Simon works on the cancer ward of the Bonn University Children's Clinic. As far as the treatment of wounds is concerned, his young patients form part of a high-risk group: the medication used to treat cancer known as cytostatics not only slows down the reproduction of malignant cells, but also impairs the healing process of wounds. 'Normally a skin injury heals in a week, with our children it often takes a month or more,' he says. Moreover, children with leukaemia have a weakened immune system. If a germ enters their bloodstream via a wound, the result may be a fatal case of blood poisoning.
For several years now Bonn paediatricians have been pioneering the use in Germany of medihoney in treating wounds. Medihoney bears the CE seal for medical products; its quality is regularly tested. The success is astonishing: 'Dead tissue is rejected faster, and the wounds heals more rapidly,' Kai Sofka, wound specialist at the University Children's Clinic, emphasises. 'What is more, changing dressings is less painful, since the poultices are easier to remove without damaging the newly formed layers of skin.' Some wounds often smell unpleasant - an enormous strain on the patient. Yet honey helps here too by reducing the smell. 'Even wounds which consistently refused to heal for years can, in our experience, be brought under control with medihoney - and this frequently happens within a few weeks,' Kai Sofka says.
In the meantime two dozen hospitals in Germany are using honey in their treatment of wounds. Despite all the success there have hitherto been very few reliable clinical studies of its effectiveness. In conjunction with colleagues from D?sseldorf, Homburg and Berlin, the Bonn medical staff now want to remedy this. With the Woundpecker Data Bank, which they have developed themselves, they will be recording and evalu-ating over 100 courses of disease over the next few months. The next step planned is comparative studies with other therapeutic methods such as the very expensive cationic silver dressings. 'These too are an effective anti-bacterial method,' says Dr. Arne Simon. 'However, it is not yet clear whether the silver released from some dressings may lead to side-effects among children.' Effective bacteria killer
It has already been proved that medihoney even puts paid to multi-resistant germs such as MRSA. In this respect medihoney is neck and neck in the race to beat the antibiotic mupirocin, currently the local MRSA antibiotic of choice. This is shown by a study recently published by researchers in Australia. In one point medihoney was even superior to its rival: the bacteria did not develop any resistance to the natural product during the course of treatment.
It is also known today why honey has an antiseptic effect: when producing honey, bees add an enzyme called glucose-oxidase. This enzyme ensures that small amounts of hydrogen peroxide, an effective antiseptic, are constantly being formed from the sugar in the honey. The advantage over the hydrogen peroxide from the chemist's is that small concentrations are sufficient to kill the germs, as it is constantly being produced. As a rule much larger quantities of hydrogen peroxide would have to be used, as hydrogen peroxide loses its potency over time. However, in large concentrations it not only damages the bacteria, but also the skin cells.
Furthermore, medihoney consists of two different types of honey: one which forms a comparatively large amount of hydrogen peroxide, and another known as 'lepto-spermum honey'. Leptospermum is a species of tree which occurs in New Zealand and Australia. Honey from these trees has a particularly strong anti-bacterial effect, even in a 10% dilution. 'It is not yet known exactly why this is,' Dr. Arne Simon says. 'Probably it is a mix of phenol-type substances which come from the plant and make life particularly difficult for the bacteria in the wound.'
Contact: Dr. Arne Simon
University of Bonn
The fact that honey can help wounds to heal is something that was known to the Ancient Egyptians several thousand years ago. And in the last two world wars poultices with honey were used to assist the healing process in soldiers' wounds. However, the rise of the new antibiotics replaced this household remedy. 'In hospitals today we are faced with germs which are resistant to almost all the current anti-biotics,' Dr. Arne Simon explains. 'As a result, the medical use of honey is becoming attractive again for the treatment of wounds.'
Dr. Simon works on the cancer ward of the Bonn University Children's Clinic. As far as the treatment of wounds is concerned, his young patients form part of a high-risk group: the medication used to treat cancer known as cytostatics not only slows down the reproduction of malignant cells, but also impairs the healing process of wounds. 'Normally a skin injury heals in a week, with our children it often takes a month or more,' he says. Moreover, children with leukaemia have a weakened immune system. If a germ enters their bloodstream via a wound, the result may be a fatal case of blood poisoning.
For several years now Bonn paediatricians have been pioneering the use in Germany of medihoney in treating wounds. Medihoney bears the CE seal for medical products; its quality is regularly tested. The success is astonishing: 'Dead tissue is rejected faster, and the wounds heals more rapidly,' Kai Sofka, wound specialist at the University Children's Clinic, emphasises. 'What is more, changing dressings is less painful, since the poultices are easier to remove without damaging the newly formed layers of skin.' Some wounds often smell unpleasant - an enormous strain on the patient. Yet honey helps here too by reducing the smell. 'Even wounds which consistently refused to heal for years can, in our experience, be brought under control with medihoney - and this frequently happens within a few weeks,' Kai Sofka says.
In the meantime two dozen hospitals in Germany are using honey in their treatment of wounds. Despite all the success there have hitherto been very few reliable clinical studies of its effectiveness. In conjunction with colleagues from D?sseldorf, Homburg and Berlin, the Bonn medical staff now want to remedy this. With the Woundpecker Data Bank, which they have developed themselves, they will be recording and evalu-ating over 100 courses of disease over the next few months. The next step planned is comparative studies with other therapeutic methods such as the very expensive cationic silver dressings. 'These too are an effective anti-bacterial method,' says Dr. Arne Simon. 'However, it is not yet clear whether the silver released from some dressings may lead to side-effects among children.' Effective bacteria killer
It has already been proved that medihoney even puts paid to multi-resistant germs such as MRSA. In this respect medihoney is neck and neck in the race to beat the antibiotic mupirocin, currently the local MRSA antibiotic of choice. This is shown by a study recently published by researchers in Australia. In one point medihoney was even superior to its rival: the bacteria did not develop any resistance to the natural product during the course of treatment.
It is also known today why honey has an antiseptic effect: when producing honey, bees add an enzyme called glucose-oxidase. This enzyme ensures that small amounts of hydrogen peroxide, an effective antiseptic, are constantly being formed from the sugar in the honey. The advantage over the hydrogen peroxide from the chemist's is that small concentrations are sufficient to kill the germs, as it is constantly being produced. As a rule much larger quantities of hydrogen peroxide would have to be used, as hydrogen peroxide loses its potency over time. However, in large concentrations it not only damages the bacteria, but also the skin cells.
Furthermore, medihoney consists of two different types of honey: one which forms a comparatively large amount of hydrogen peroxide, and another known as 'lepto-spermum honey'. Leptospermum is a species of tree which occurs in New Zealand and Australia. Honey from these trees has a particularly strong anti-bacterial effect, even in a 10% dilution. 'It is not yet known exactly why this is,' Dr. Arne Simon says. 'Probably it is a mix of phenol-type substances which come from the plant and make life particularly difficult for the bacteria in the wound.'
Contact: Dr. Arne Simon
University of Bonn
пятница, 17 июня 2011 г.
New Drug For Skin Cancer Approaching Commercialization
A drug that is activated by light can be a quick, simple, and cheap treatment for tens of thousands of patients with skin cancer in Sweden alone. Researcher Leif Eriksson's team at rebro University in Sweden has now received about SEK 4 million from government research financiers, the Swedish Research Council and Vinnova, to further develop and commercialize the method.
The new drug that the rebro researchers have developed is based on the use of photo-dynamic therapy in cancer treatment. In short, this is a drug that after reorganization in the cell is activated by light, which in turn leads to chemical reactions that effectively kills cancer cells.
With this method, a majority of the some 30,000 new cases of skin cancer discovered each year in Sweden alone could be treated quickly, simply, and cost effectively. This is also true for pre-stages of skin cancer, so-called actinic keratosis.
"It's extremely gratifying that two of the most important research financiers in Sweden so actively support our research," says Leif Eriksson, professor of biophysical and theoretical chemistry at rebro University.
Leif Eriksson's drug research has grown out of the rebro Life Science Center (OLSC), an interdisciplinary, internationally acclaimed research node at rebro University. Research on new forms of treatment for skin tumors is also being conducted in collaboration with Associate Professor Lennart L?¶fgren at the Center for Head and Neck Oncology at rebro University Hospital.
"Our drug, and the new treatment concept we are developing together with researchers in Belfast, has tremendous potential. In the coming year we will also see further patents as a direct result of the collaboration with other research teams within the OLSC, including treatments for atherosclerosis and autoimmune disorders such as rheumatism," says Leif Eriksson.
The development of new drugs is being carried out with the aid of advanced computer modeling a method that has proven to be highly successful.
"We provide the expertise in the theoretical description of new drugs. In our research we aim to describe at a detailed level what they should look like, what properties they should have to match the right targets in the body, what happens if we alter the molecules in different ways, etc. We then put this together through collaboration with experimental or clinically active research teams within OLSC and at the hospital, which makes the research exciting and dynamic," says Leif Eriksson.
Vetenskapsradet (The Swedish Research Council)
vr.se
The new drug that the rebro researchers have developed is based on the use of photo-dynamic therapy in cancer treatment. In short, this is a drug that after reorganization in the cell is activated by light, which in turn leads to chemical reactions that effectively kills cancer cells.
With this method, a majority of the some 30,000 new cases of skin cancer discovered each year in Sweden alone could be treated quickly, simply, and cost effectively. This is also true for pre-stages of skin cancer, so-called actinic keratosis.
"It's extremely gratifying that two of the most important research financiers in Sweden so actively support our research," says Leif Eriksson, professor of biophysical and theoretical chemistry at rebro University.
Leif Eriksson's drug research has grown out of the rebro Life Science Center (OLSC), an interdisciplinary, internationally acclaimed research node at rebro University. Research on new forms of treatment for skin tumors is also being conducted in collaboration with Associate Professor Lennart L?¶fgren at the Center for Head and Neck Oncology at rebro University Hospital.
"Our drug, and the new treatment concept we are developing together with researchers in Belfast, has tremendous potential. In the coming year we will also see further patents as a direct result of the collaboration with other research teams within the OLSC, including treatments for atherosclerosis and autoimmune disorders such as rheumatism," says Leif Eriksson.
The development of new drugs is being carried out with the aid of advanced computer modeling a method that has proven to be highly successful.
"We provide the expertise in the theoretical description of new drugs. In our research we aim to describe at a detailed level what they should look like, what properties they should have to match the right targets in the body, what happens if we alter the molecules in different ways, etc. We then put this together through collaboration with experimental or clinically active research teams within OLSC and at the hospital, which makes the research exciting and dynamic," says Leif Eriksson.
Vetenskapsradet (The Swedish Research Council)
vr.se
четверг, 16 июня 2011 г.
New Survey Finds Teenage Boys Least Likely to Practice Proper Sun Protection
The old adage "boys will be boys"
epitomizes the reckless abandon with which most boys view life -- whether it's
racing dirt bikes on slick streets without wearing a helmet or spending
countless hours on the beach without an ounce of sunscreen for protection.
Now a new survey by the American Academy of Dermatology (Academy) confirms
that teenage boys are the worst violators when it comes to protecting
themselves from the sun. This may explain why studies cite middle-age and
older men with higher rates of skin cancer than any other gender or age group.
Speaking today at the Academy's Melanoma/Skin Cancer Detection and
Prevention Month news conference, dermatologist Darrell S. Rigel, M.D.,
clinical professor, New York University Medical Center in New York, N.Y.,
presented new data on teen boys' attitudes about sun protection and why their
behavior translates into an increased risk for developing skin cancer later in
life.
"Without a doubt, teenagers are always the hardest demographic to reach
with any health warning," explained Dr. Rigel. "They don't equate their bad
behavior in the present with bad things happening to them later in life as a
consequence. Skin cancer is no exception."
Boys to Men
When it comes to playing it safe in the sun, the Academy survey found that
teenage boys are least likely to stay out of harm's way. In fact, older teen
boys (aged 15 to 17) are the least careful when it comes to protecting their
skin from sun exposure -- with only 32 percent of those surveyed reporting
that they are very or somewhat careful.
This lax behavior could explain findings from a previous study published
in the January 2003 issue of the Journal of the American Academy of
Dermatology in which older white men had a higher incidence of skin cancer.
By examining data obtained from the Academy's Skin Cancer Screening Program,
where dermatologists provide free skin cancer screenings to consumers, the
study concluded that the majority (44 percent) of individuals diagnosed with
melanoma -- the deadliest form of skin cancer -- were white men over the age
of 50. These men accounted for fewer than 20 percent of all individuals
screened during the three-year time period when the data was examined,
suggesting that the incidence of skin cancer would be even higher in this
demographic if more older men participated in the screenings.
"Invasive melanoma, which is the hardest type of skin cancer to treat, is
currently the fifth most common cancer in men," said Dr. Rigel. "While skin
cancer can take years to develop, we need to reach teenage boys now to
influence their behavior and reverse this alarming trend. Otherwise, the odds
are extremely high that they will develop this potentially deadly form of skin
cancer when they get older."
Boys vs. Girls
The survey also compared the sun protection attitudes of boys and girls.
"While boys are more careless, the survey found there are interesting
differences between boys and girls when it comes to heeding our advice,"
stated Dr. Rigel.
When asked how careful they are about protecting their skin from the sun,
older teenage boys were the least vigilant compared to younger boys and girls
of all ages. Among 15- to 17-year-old boys, only 32 percent reported that
they are very careful or somewhat careful about protecting their skin from sun
exposure -- compared to 58 percent of girls of the same age.
Across the board, both younger and older teen boys (age 12 to 17) were
less cautious in the sun than teenage girls (age 12 to 17). Considerably
fewer boys reported wearing protective clothing and seeking shade when
outdoors for long periods of time compared to girls, and only 33 percent of
boys said that they apply sunscreen when they are going to be out in the sun
vs. 53 percent of girls.
One area that boys fared better than girls was when they were asked if
they wear hats when outdoors in the sun (50 percent of boys vs. 22 percent of
girls), although Dr. Rigel noted that these hats tend to be baseball caps
instead of wide-brimmed hats that provide the recommended sun protection.
"While baseball caps are better than wearing no hat at all, they don't
adequately protect the neck and ears from sun exposure," said Dr. Rigel.
Among all teens, younger teens (age 12 to 14) tend to be more vigilant
about protecting themselves from the sun than older teens (age 15 to 17).
When asked about how careful they are to protect their skin from the sun, 52
percent of the younger teens reported that they are very or somewhat careful
vs. only 43 percent of older teens.
"With younger teens, parents still have influence on their child's
behavior which makes them more likely to wear sunscreen and protective
clothing when they are going to be outdoors for a long period of time," added
Dr. Rigel. "On the other hand, older teens start exerting their independence
and tend to ignore their parents' advice -- including practicing proper sun
protection."
When asked about their use of tanning beds in the last year, boys were
less likely to engage in this dangerous activity than girls -- with only
5 percent of boys reporting that they used a tanning bed last year vs.
19 percent of girls. The majority of girls who used a tanning bed
(39 percent) noted that the reason they did was to get a tan for a special
occasion, such as a wedding or prom.
In March 2005, the World Health Organization (WHO) formally recognized the
potential dangers that indoor tanning poses to minors and recommended that no
person under the age of 18 should use a tanning bed. The American Academy of
Dermatology Association (AADA) position statement on indoor tanning encourages
states to aggressively pursue legislation that protects children.
Specifically, the AADA supports the following requirements for indoor
tanning facilities:
-- No minor should be permitted to use tanning devices.
-- A Surgeon General's warning should be placed on all tanning devices.
-- No person or facility should advertise the use of any ultraviolet A or
ultraviolet B tanning device using wording such as "safe," "safe
tanning," "no harmful rays," "no adverse effect," or similar wording
or concepts.
"Skin cancer is preventable but until teens change their behavior, we'll
continue to see skin cancer rates continue to rise in this country," said Dr.
Rigel.
The study results were determined by a random sample telephone survey
conducted among a national sample of 505 teens comprising 254 males and 251
females 12 to 17 years of age, living in private households in the continental
United States. This TEEN CARAVAN(R) survey was conducted in February 2005 by
Opinion Research Corporation (Princeton, N.J.) in collaboration with the
Academy.
For more information about skin cancer, visit the Academy's patient
education Web site at skincarephysicians and
select
"SkinCancerNet."
Headquartered in Schaumburg, Ill., the American Academy of Dermatology
(Academy), founded in 1938, is the largest, most influential, and most
representative of all dermatologic associations. With a membership of more
than 14,000 physicians worldwide, the Academy is committed to: advancing the
diagnosis and medical, surgical and cosmetic treatment of the skin, hair and
nails; advocating high standards in clinical practice, education, and research
in dermatology; and supporting and enhancing patient care for a lifetime of
healthier skin, hair and nails. For more information, contact the Academy at
1-888-462-DERM (3376) or aad.
epitomizes the reckless abandon with which most boys view life -- whether it's
racing dirt bikes on slick streets without wearing a helmet or spending
countless hours on the beach without an ounce of sunscreen for protection.
Now a new survey by the American Academy of Dermatology (Academy) confirms
that teenage boys are the worst violators when it comes to protecting
themselves from the sun. This may explain why studies cite middle-age and
older men with higher rates of skin cancer than any other gender or age group.
Speaking today at the Academy's Melanoma/Skin Cancer Detection and
Prevention Month news conference, dermatologist Darrell S. Rigel, M.D.,
clinical professor, New York University Medical Center in New York, N.Y.,
presented new data on teen boys' attitudes about sun protection and why their
behavior translates into an increased risk for developing skin cancer later in
life.
"Without a doubt, teenagers are always the hardest demographic to reach
with any health warning," explained Dr. Rigel. "They don't equate their bad
behavior in the present with bad things happening to them later in life as a
consequence. Skin cancer is no exception."
Boys to Men
When it comes to playing it safe in the sun, the Academy survey found that
teenage boys are least likely to stay out of harm's way. In fact, older teen
boys (aged 15 to 17) are the least careful when it comes to protecting their
skin from sun exposure -- with only 32 percent of those surveyed reporting
that they are very or somewhat careful.
This lax behavior could explain findings from a previous study published
in the January 2003 issue of the Journal of the American Academy of
Dermatology in which older white men had a higher incidence of skin cancer.
By examining data obtained from the Academy's Skin Cancer Screening Program,
where dermatologists provide free skin cancer screenings to consumers, the
study concluded that the majority (44 percent) of individuals diagnosed with
melanoma -- the deadliest form of skin cancer -- were white men over the age
of 50. These men accounted for fewer than 20 percent of all individuals
screened during the three-year time period when the data was examined,
suggesting that the incidence of skin cancer would be even higher in this
demographic if more older men participated in the screenings.
"Invasive melanoma, which is the hardest type of skin cancer to treat, is
currently the fifth most common cancer in men," said Dr. Rigel. "While skin
cancer can take years to develop, we need to reach teenage boys now to
influence their behavior and reverse this alarming trend. Otherwise, the odds
are extremely high that they will develop this potentially deadly form of skin
cancer when they get older."
Boys vs. Girls
The survey also compared the sun protection attitudes of boys and girls.
"While boys are more careless, the survey found there are interesting
differences between boys and girls when it comes to heeding our advice,"
stated Dr. Rigel.
When asked how careful they are about protecting their skin from the sun,
older teenage boys were the least vigilant compared to younger boys and girls
of all ages. Among 15- to 17-year-old boys, only 32 percent reported that
they are very careful or somewhat careful about protecting their skin from sun
exposure -- compared to 58 percent of girls of the same age.
Across the board, both younger and older teen boys (age 12 to 17) were
less cautious in the sun than teenage girls (age 12 to 17). Considerably
fewer boys reported wearing protective clothing and seeking shade when
outdoors for long periods of time compared to girls, and only 33 percent of
boys said that they apply sunscreen when they are going to be out in the sun
vs. 53 percent of girls.
One area that boys fared better than girls was when they were asked if
they wear hats when outdoors in the sun (50 percent of boys vs. 22 percent of
girls), although Dr. Rigel noted that these hats tend to be baseball caps
instead of wide-brimmed hats that provide the recommended sun protection.
"While baseball caps are better than wearing no hat at all, they don't
adequately protect the neck and ears from sun exposure," said Dr. Rigel.
Among all teens, younger teens (age 12 to 14) tend to be more vigilant
about protecting themselves from the sun than older teens (age 15 to 17).
When asked about how careful they are to protect their skin from the sun, 52
percent of the younger teens reported that they are very or somewhat careful
vs. only 43 percent of older teens.
"With younger teens, parents still have influence on their child's
behavior which makes them more likely to wear sunscreen and protective
clothing when they are going to be outdoors for a long period of time," added
Dr. Rigel. "On the other hand, older teens start exerting their independence
and tend to ignore their parents' advice -- including practicing proper sun
protection."
When asked about their use of tanning beds in the last year, boys were
less likely to engage in this dangerous activity than girls -- with only
5 percent of boys reporting that they used a tanning bed last year vs.
19 percent of girls. The majority of girls who used a tanning bed
(39 percent) noted that the reason they did was to get a tan for a special
occasion, such as a wedding or prom.
In March 2005, the World Health Organization (WHO) formally recognized the
potential dangers that indoor tanning poses to minors and recommended that no
person under the age of 18 should use a tanning bed. The American Academy of
Dermatology Association (AADA) position statement on indoor tanning encourages
states to aggressively pursue legislation that protects children.
Specifically, the AADA supports the following requirements for indoor
tanning facilities:
-- No minor should be permitted to use tanning devices.
-- A Surgeon General's warning should be placed on all tanning devices.
-- No person or facility should advertise the use of any ultraviolet A or
ultraviolet B tanning device using wording such as "safe," "safe
tanning," "no harmful rays," "no adverse effect," or similar wording
or concepts.
"Skin cancer is preventable but until teens change their behavior, we'll
continue to see skin cancer rates continue to rise in this country," said Dr.
Rigel.
The study results were determined by a random sample telephone survey
conducted among a national sample of 505 teens comprising 254 males and 251
females 12 to 17 years of age, living in private households in the continental
United States. This TEEN CARAVAN(R) survey was conducted in February 2005 by
Opinion Research Corporation (Princeton, N.J.) in collaboration with the
Academy.
For more information about skin cancer, visit the Academy's patient
education Web site at skincarephysicians and
select
"SkinCancerNet."
Headquartered in Schaumburg, Ill., the American Academy of Dermatology
(Academy), founded in 1938, is the largest, most influential, and most
representative of all dermatologic associations. With a membership of more
than 14,000 physicians worldwide, the Academy is committed to: advancing the
diagnosis and medical, surgical and cosmetic treatment of the skin, hair and
nails; advocating high standards in clinical practice, education, and research
in dermatology; and supporting and enhancing patient care for a lifetime of
healthier skin, hair and nails. For more information, contact the Academy at
1-888-462-DERM (3376) or aad.
среда, 15 июня 2011 г.
Scalp Cooling Cap May Help Chemotherapy Patients Keep Hair
A feasibility study to test the use of a scalp cooling device that breast cancer patients will wear while undergoing chemotherapy treatment will be conducted at Wake Forest University Baptist Medical Center. This will be part of the first significant study of the medical device in the United States.
The FDA has given approval for an investigational device exemption (IDE) feasibility study to be conducted at both Wake Forest Baptist and University of California, San Francisco (UCSF). A total of 20 patients with stage one breast cancer will be involved - 10 at Wake Forest Baptist and 10 at UCSF. The study will test the safety and tolerability of the patented DigniCap™ scalp cooling system which is worn by patients during chemotherapy treatment to prevent hair loss. The IDE feasibility study is the first step required to gain FDA approval.
The scalp cooling device is already in clinical use throughout Europe, Canada and Japan.
Susan Melin, M.D., principal investigator for the study, said data from several large international studies involving almost 1,000 chemotherapy patients indicate the device is safe to use and does prevent hair loss. Melin is an associate professor of Internal Medicine-Hematology and Oncology at Wake Forest Baptist who specializes in breast cancer.
"One of the first questions my patients ask is whether they will lose their hair with the chemotherapy recommended for their breast cancer," Melin said. "Preventing chemotherapy-induced hair loss by using the scalp cooling cap may relieve severe psychological and emotional stress and improve the patient's quality of life."
The DigniCap™ system, developed by the Swedish company Dignitana, features a tight-fitting silicone cap that is placed directly on the head and an outer neoprene cap that insulates and secures the inner one. The cap is connected to a cooling and control unit with touch screen controls. A coolant circulates throughout the inner silicone layer, and the cap is designed to deliver consistent cooling to all areas of the scalp. The device features safety sensors that continuously monitor and optimize the treatment temperature.
When a cap is applied to the head, the temperature of the scalp is lowered and blood vessels surrounding the hair roots contract, resulting in a significant reduction of cytotoxins to the follicle. Reduced blood flow leaves a smaller amount of chemotherapy available for uptake in the cells, and the decreased temperature results in less absorption of and reduced effects from chemotherapy. These factors together reduce the risk of hair loss.
Melin said that a larger efficacy study would include patients with stage one or stage two breast cancer. "Basically, the Dignicap would be used for certain patients who have a moderate chance of their cancer recurring," she said.
The DigniCap™ system was invented and commercially launched early 2001 and the patented innovation is by Swedish oncology nurse Yvonne Olofsson, who was moved to help her patients cope with the emotionally traumatic condition of hair loss following cytotoxic therapy for cancer.
The FDA has given approval for an investigational device exemption (IDE) feasibility study to be conducted at both Wake Forest Baptist and University of California, San Francisco (UCSF). A total of 20 patients with stage one breast cancer will be involved - 10 at Wake Forest Baptist and 10 at UCSF. The study will test the safety and tolerability of the patented DigniCap™ scalp cooling system which is worn by patients during chemotherapy treatment to prevent hair loss. The IDE feasibility study is the first step required to gain FDA approval.
The scalp cooling device is already in clinical use throughout Europe, Canada and Japan.
Susan Melin, M.D., principal investigator for the study, said data from several large international studies involving almost 1,000 chemotherapy patients indicate the device is safe to use and does prevent hair loss. Melin is an associate professor of Internal Medicine-Hematology and Oncology at Wake Forest Baptist who specializes in breast cancer.
"One of the first questions my patients ask is whether they will lose their hair with the chemotherapy recommended for their breast cancer," Melin said. "Preventing chemotherapy-induced hair loss by using the scalp cooling cap may relieve severe psychological and emotional stress and improve the patient's quality of life."
The DigniCap™ system, developed by the Swedish company Dignitana, features a tight-fitting silicone cap that is placed directly on the head and an outer neoprene cap that insulates and secures the inner one. The cap is connected to a cooling and control unit with touch screen controls. A coolant circulates throughout the inner silicone layer, and the cap is designed to deliver consistent cooling to all areas of the scalp. The device features safety sensors that continuously monitor and optimize the treatment temperature.
When a cap is applied to the head, the temperature of the scalp is lowered and blood vessels surrounding the hair roots contract, resulting in a significant reduction of cytotoxins to the follicle. Reduced blood flow leaves a smaller amount of chemotherapy available for uptake in the cells, and the decreased temperature results in less absorption of and reduced effects from chemotherapy. These factors together reduce the risk of hair loss.
Melin said that a larger efficacy study would include patients with stage one or stage two breast cancer. "Basically, the Dignicap would be used for certain patients who have a moderate chance of their cancer recurring," she said.
The DigniCap™ system was invented and commercially launched early 2001 and the patented innovation is by Swedish oncology nurse Yvonne Olofsson, who was moved to help her patients cope with the emotionally traumatic condition of hair loss following cytotoxic therapy for cancer.
вторник, 14 июня 2011 г.
Study Identifies Risk Factors For Transformation Of Eye Growths Into Melanoma
Eight factors may predict whether a choroidal nevus-a benign, flat, pigmented growth inside the eye and beneath the retina-may develop into melanoma, according to a report in the August issue of Archives of Ophthalmology, one of the JAMA/Archives journals.
"There is strong interest for early detection of choroidal melanoma [a malignant growth], and its differentiation from nevus continues to be the major impediment," the authors write as background information in the article. Benign choroidal nevi and small melanomas share many characteristics, including color, location and size. "The challenge is to identify the single small melanoma among the thousands of choroidal nevi. It has been estimated that 6 percent of the white population harbors a choroidal nevus and that one in approximately 8,000 of these nevi transform into melanoma."
Carol L. Shields, M.D., and colleagues at Wills Eye Institute, Thomas Jefferson University, Philadelphia, studied the medical records of 2,514 consecutive eyes of patients with choroidal nevi between 1974 and 2006. The tumors had a median (midpoint) diameter of 5 millimeters and a median thickness of 1.5 millimeters at the beginning of the study. Choroidal nevi grew into melanoma in a total of 180 eyes (7 percent) over an average follow-up of 53 months, including 2 percent after one year, 9 percent after five years and 13 percent after ten years.
The factors that predicted growth into melanoma included five previously identified factors: tumor thickness greater than 2 millimeters, fluid beneath the retina, symptoms such as decreased vision or flashes and floaters, orange pigment and a tumor edge within 3 millimeters of the optic disc. Two new factors were also identified: hollowness of the growth on ultrasound and the absence of a surrounding halo, or circular band of depigmentation.
"Until systemic therapies for metastastic uveal melanoma improve, our focus should be on early detection to minimize metastastic disease," the authors write. "All ophthalmologists should participate in this effort and patients with risk factors can be referred for evaluation at centers familiar with the nuances in the diagnosis and management of early melanoma."
Patients with choroidal nevi that do not display any of the seven features of disease should be monitored twice yearly at first and then followed up yearly if their condition remains stable; those with one or two features should be monitored every four to six months; and those with three or more features should be evaluated at an experienced center for possible treatment, they conclude.
Archives of Ophthalmology. 2009;127[8]:981-987.
Source
Archives of Opthalmology
"There is strong interest for early detection of choroidal melanoma [a malignant growth], and its differentiation from nevus continues to be the major impediment," the authors write as background information in the article. Benign choroidal nevi and small melanomas share many characteristics, including color, location and size. "The challenge is to identify the single small melanoma among the thousands of choroidal nevi. It has been estimated that 6 percent of the white population harbors a choroidal nevus and that one in approximately 8,000 of these nevi transform into melanoma."
Carol L. Shields, M.D., and colleagues at Wills Eye Institute, Thomas Jefferson University, Philadelphia, studied the medical records of 2,514 consecutive eyes of patients with choroidal nevi between 1974 and 2006. The tumors had a median (midpoint) diameter of 5 millimeters and a median thickness of 1.5 millimeters at the beginning of the study. Choroidal nevi grew into melanoma in a total of 180 eyes (7 percent) over an average follow-up of 53 months, including 2 percent after one year, 9 percent after five years and 13 percent after ten years.
The factors that predicted growth into melanoma included five previously identified factors: tumor thickness greater than 2 millimeters, fluid beneath the retina, symptoms such as decreased vision or flashes and floaters, orange pigment and a tumor edge within 3 millimeters of the optic disc. Two new factors were also identified: hollowness of the growth on ultrasound and the absence of a surrounding halo, or circular band of depigmentation.
"Until systemic therapies for metastastic uveal melanoma improve, our focus should be on early detection to minimize metastastic disease," the authors write. "All ophthalmologists should participate in this effort and patients with risk factors can be referred for evaluation at centers familiar with the nuances in the diagnosis and management of early melanoma."
Patients with choroidal nevi that do not display any of the seven features of disease should be monitored twice yearly at first and then followed up yearly if their condition remains stable; those with one or two features should be monitored every four to six months; and those with three or more features should be evaluated at an experienced center for possible treatment, they conclude.
Archives of Ophthalmology. 2009;127[8]:981-987.
Source
Archives of Opthalmology
понедельник, 13 июня 2011 г.
Physician Coalition Responds To Growing Concerns In Injectable Safety
The Physicians Coalition for
Injectable Safety announced today the launch of a public awareness campaign
on the safe use of injectable therapies. The Physicians Coalition for
Injectable Safety is an alliance of physician organizations including the
American Society of Aesthetic Plastic Surgeons, American Academy of Facial
Plastic and Reconstructive Surgery, and the American Society for
Dermatologic Surgery. The Coalition was formed to raise awareness of the
appropriate use and setting for receiving injectable therapies. Information
on the injectable therapies and the Coalition can be found at
injectablesafety.
"The specialties that have pioneered and advanced cosmetic treatment
with injectables have come together as a group in support of the value that
cosmetic injectable treatments provide patients, but we are concerned that
troubling reports and requests for help from patients hurt by counterfeit
or so-called 'off-shore' injectables or by untrained injectors are
growing," said Mark L. Jewell, MD, Chair of the Coalition and past
president of the American Society for Aesthetic Plastic Surgery (ASAPS).
According to ASAPS' 2006 statistics, last year 5.7 million injectable
procedures were performed for cosmetic purposes. Treatments are U.S. FDA
approved products designed to treat facial wrinkles, improve the signs of
aging, enhance facial appearance and treat skin imperfections. Consumers
are encouraged to choose a board certified physician who regularly performs
cosmetic procedures of the face and skin (plastic surgeon, dermatologist,
facial plastic surgeon or ophthalmic plastic surgeon) and who uses FDA
approved injectables.
"Despite the perception these are non-invasive treatments, these
injections are medical procedures that should only be administered in a
medical setting. Patients should have confidence the person prescribing and
performing the injection has the appropriate training and the product is
genuine," said Alastair Carruthers, FRCPC president of the American Society
for Dermatologic Surgery.
The Physicians Coalition for Injectable Safety has launched
injectablesafety, a web resource about U.S. FDA approved
injectables, how to choose a qualified provider and the benefits and risks
of injectable therapies. The web site was written by board certified
physicians to provide consumers with objective and factual information
about injectable cosmetic enhancement. Support for the Coalition and its
initiatives including injectablesafety has been provided in
part by unrestricted educational grants from Allergan, Artes Medical,
BioForm Medical, and Medicis.
About ASAPS
The 2400-member American Society for Aesthetic Plastic Surgery (ASAPS)
is the only plastic surgery organization devoted entirely to the
advancement of cosmetic surgery. ASAPS is recognized throughout the world
as the authoritative source for cosmetic surgery education. U.S. members
are certified by the American Board of Plastic Surgery. Canadian members
are certified in plastic surgery by the Royal College of Physicians and
Surgeons of Canada.
About ASDS
With more than 4,700 members, ASDS, founded in 1970, is the largest
specialty organization in the world exclusively representing dermatologic
surgeons, board-certified physicians who are specifically trained to treat
the health, function and appearance of the skin and soft tissue, with both
medically necessary and cosmetic procedures, using both surgical and
non-surgical methods.
About AAFPRS
The American Academy of Facial Plastic and Reconstructive Surgery is
the world's largest specialty association that represents over 2,700 facial
plastic and reconstructive surgeons throughout the world. The AAFPRS is a
National Medical Specialty Society of the American Medical Association
(AMA), and holds an official seat in both the AMA House of Delegates and
the American College of Surgeons board of governors. AAFPRS members are
board certified surgeons whose focus is surgery of the face, head, and
neck.
American Society for Aesthetic Plastic Surgery
injectablesafety
Injectable Safety announced today the launch of a public awareness campaign
on the safe use of injectable therapies. The Physicians Coalition for
Injectable Safety is an alliance of physician organizations including the
American Society of Aesthetic Plastic Surgeons, American Academy of Facial
Plastic and Reconstructive Surgery, and the American Society for
Dermatologic Surgery. The Coalition was formed to raise awareness of the
appropriate use and setting for receiving injectable therapies. Information
on the injectable therapies and the Coalition can be found at
injectablesafety.
"The specialties that have pioneered and advanced cosmetic treatment
with injectables have come together as a group in support of the value that
cosmetic injectable treatments provide patients, but we are concerned that
troubling reports and requests for help from patients hurt by counterfeit
or so-called 'off-shore' injectables or by untrained injectors are
growing," said Mark L. Jewell, MD, Chair of the Coalition and past
president of the American Society for Aesthetic Plastic Surgery (ASAPS).
According to ASAPS' 2006 statistics, last year 5.7 million injectable
procedures were performed for cosmetic purposes. Treatments are U.S. FDA
approved products designed to treat facial wrinkles, improve the signs of
aging, enhance facial appearance and treat skin imperfections. Consumers
are encouraged to choose a board certified physician who regularly performs
cosmetic procedures of the face and skin (plastic surgeon, dermatologist,
facial plastic surgeon or ophthalmic plastic surgeon) and who uses FDA
approved injectables.
"Despite the perception these are non-invasive treatments, these
injections are medical procedures that should only be administered in a
medical setting. Patients should have confidence the person prescribing and
performing the injection has the appropriate training and the product is
genuine," said Alastair Carruthers, FRCPC president of the American Society
for Dermatologic Surgery.
The Physicians Coalition for Injectable Safety has launched
injectablesafety, a web resource about U.S. FDA approved
injectables, how to choose a qualified provider and the benefits and risks
of injectable therapies. The web site was written by board certified
physicians to provide consumers with objective and factual information
about injectable cosmetic enhancement. Support for the Coalition and its
initiatives including injectablesafety has been provided in
part by unrestricted educational grants from Allergan, Artes Medical,
BioForm Medical, and Medicis.
About ASAPS
The 2400-member American Society for Aesthetic Plastic Surgery (ASAPS)
is the only plastic surgery organization devoted entirely to the
advancement of cosmetic surgery. ASAPS is recognized throughout the world
as the authoritative source for cosmetic surgery education. U.S. members
are certified by the American Board of Plastic Surgery. Canadian members
are certified in plastic surgery by the Royal College of Physicians and
Surgeons of Canada.
About ASDS
With more than 4,700 members, ASDS, founded in 1970, is the largest
specialty organization in the world exclusively representing dermatologic
surgeons, board-certified physicians who are specifically trained to treat
the health, function and appearance of the skin and soft tissue, with both
medically necessary and cosmetic procedures, using both surgical and
non-surgical methods.
About AAFPRS
The American Academy of Facial Plastic and Reconstructive Surgery is
the world's largest specialty association that represents over 2,700 facial
plastic and reconstructive surgeons throughout the world. The AAFPRS is a
National Medical Specialty Society of the American Medical Association
(AMA), and holds an official seat in both the AMA House of Delegates and
the American College of Surgeons board of governors. AAFPRS members are
board certified surgeons whose focus is surgery of the face, head, and
neck.
American Society for Aesthetic Plastic Surgery
injectablesafety
воскресенье, 12 июня 2011 г.
HemCon Medical Technologies, Inc. Announces Promising Results From Nail Anti-Fungal Study
HemCon Medical Technologies today announced the completion of two independent studies on its topical treatment of Onychomycosis, a common fungal nail infection. The studies were conducted with a formulation based on HemCon's newest proprietary platform technology that provides a controlled release broad spectrum antifungal and antibacterial agent to fight infection.
Independent testing of HemCon's topical formulation for the treatment of Onychomycosis was analyzed by MedPharm Ltd. using their industry-leading TurChub® test system. This system tests the penetration of human nails by the test substance and subsequent killing of the fungal infection underneath. HemCon's formulation was evaluated against two market leading Onychomycosis treatments. The HemCon formulation successfully penetrated the nail and killed the infection to a significantly greater extent than the other treatments. In a second, human-based study, safety results indicated that no skin irritation was seen from the topical formulations of HemCon's Onychomycosis treatment.
Fungal nail infections affect tens of millions of people in the U.S. and the global market size for its treatment products is estimated at approximately US$4 billion. It is believed that 6-8 percent of all adults will acquire a fungal nail infection, and Onychomycosis is responsible for nearly 50 percent of reported cases.
"These studies confirm the exceptional promise of our new treatment, which has the potential to offer effective relief for the 40 million Americans afflicted with fungal nail infections," said John W. Morgan, CEO of HemCon. "As HemCon continues to pioneer new products that promote safe, effective healing, our solutions will also positively impact high demand markets like fungal treatment. These impressive test results will allow us to further develop products based on this new platform and offer them on a global scale."
About HemCon Medical Technologies, Inc.
HemCon Medical Technologies, Inc., is a leading global developer of advanced medical products designed to improve the standard of patient care. The company is responsible for developing the chitosan-based HemCon dressing used by thousands of military and civilian first responders and is changing wound care best practices in hospital, dental and clinical settings. In addition, HemCon is leading the charge to develop and license unique, life-saving medical advances including Lyophilized Human Plasma and Nanospider™ technologies. HemCon is headquartered in Portland, Ore., with additional commercial operations in Ireland, England, Germany and the Czech Republic. For more information, please visit hemcon.
Independent testing of HemCon's topical formulation for the treatment of Onychomycosis was analyzed by MedPharm Ltd. using their industry-leading TurChub® test system. This system tests the penetration of human nails by the test substance and subsequent killing of the fungal infection underneath. HemCon's formulation was evaluated against two market leading Onychomycosis treatments. The HemCon formulation successfully penetrated the nail and killed the infection to a significantly greater extent than the other treatments. In a second, human-based study, safety results indicated that no skin irritation was seen from the topical formulations of HemCon's Onychomycosis treatment.
Fungal nail infections affect tens of millions of people in the U.S. and the global market size for its treatment products is estimated at approximately US$4 billion. It is believed that 6-8 percent of all adults will acquire a fungal nail infection, and Onychomycosis is responsible for nearly 50 percent of reported cases.
"These studies confirm the exceptional promise of our new treatment, which has the potential to offer effective relief for the 40 million Americans afflicted with fungal nail infections," said John W. Morgan, CEO of HemCon. "As HemCon continues to pioneer new products that promote safe, effective healing, our solutions will also positively impact high demand markets like fungal treatment. These impressive test results will allow us to further develop products based on this new platform and offer them on a global scale."
About HemCon Medical Technologies, Inc.
HemCon Medical Technologies, Inc., is a leading global developer of advanced medical products designed to improve the standard of patient care. The company is responsible for developing the chitosan-based HemCon dressing used by thousands of military and civilian first responders and is changing wound care best practices in hospital, dental and clinical settings. In addition, HemCon is leading the charge to develop and license unique, life-saving medical advances including Lyophilized Human Plasma and Nanospider™ technologies. HemCon is headquartered in Portland, Ore., with additional commercial operations in Ireland, England, Germany and the Czech Republic. For more information, please visit hemcon.
суббота, 11 июня 2011 г.
New Skin-Healing Chemicals
Researchers have made synthetic lipids called pseudoceramides that are involved in skin cell growth and could be used in treating skin diseases in which skin cells grow abnormally.
Ceramides are lipids found in the outermost skin layer called the stratum corneum, which is made of dead skin cells and mainly serves as a physical barrier. Ceramides' main biological function is to control how skin cells grow and differentiate - a process through which skin cells become specialized.
Scientists have created in the laboratory synthetic ceramides, called pseudoceramides, to treat skin diseases such as atopic dermatitis, a form of eczema characterized by red, flaky and very itchy skin; psoriasis, a disease that causes red scaly patches on the skin; and glucocorticoid-induced epidermal atrophy, in which the skin shrinks due to skin cell loss.
Jeung-Hoon Lee and colleagues have developed a new series of pseudoceramides and examined their effects on skin cells. They found that three pseudoceramides called K6PC-4, K6PC-5, and K6PC-9 significantly increased the amount of proteins produced when skin cells differentiate. These results were obtained both on cultured skin cells and on a reconstituted epidermis. K6PC-4, K6PC-5, and K6PC-9 may be used to treat skin diseases arising from abnormal growth of skin cells, the scientists concluded.
Article: "Novel synthetic ceramide derivatives increase intracellular calcium levels and promote epidermal keratinocyte differentiation," by Yoo Bin Kwon, Chang Deok Kim, Jong-Kyung Youm, Hyung Sub Gwak, Byeong Deog Park, Seung Hun Lee, Saewha Jeon, Bo Joong Kim, Young-Joon Seo, Jang-Kyu Park, and Jeung-Hoon Lee
The American Society for Biochemistry and Molecular Biology is a nonprofit scientific and educational organization with over 11,900 members in the United States and internationally. Most members teach and conduct research at colleges and universities. Others conduct research in various government laboratories, nonprofit research institutions and industry. The Society's student members attend undergraduate or graduate institutions.
Founded in 1906, the Society is based in Bethesda, Maryland, on the campus of the Federation of American Societies for Experimental Biology. The Society's purpose is to advance the science of biochemistry and molecular biology through publication of the Journal of Biological Chemistry, the Journal of Lipid Research, and Molecular and Cellular Proteomics, organization of scientific meetings, advocacy for funding of basic research and education, support of science education at all levels, and promoting the diversity of individuals entering the scientific work force.
For more information about ASBMB, see the Society's Web site at asbmb.
Ceramides are lipids found in the outermost skin layer called the stratum corneum, which is made of dead skin cells and mainly serves as a physical barrier. Ceramides' main biological function is to control how skin cells grow and differentiate - a process through which skin cells become specialized.
Scientists have created in the laboratory synthetic ceramides, called pseudoceramides, to treat skin diseases such as atopic dermatitis, a form of eczema characterized by red, flaky and very itchy skin; psoriasis, a disease that causes red scaly patches on the skin; and glucocorticoid-induced epidermal atrophy, in which the skin shrinks due to skin cell loss.
Jeung-Hoon Lee and colleagues have developed a new series of pseudoceramides and examined their effects on skin cells. They found that three pseudoceramides called K6PC-4, K6PC-5, and K6PC-9 significantly increased the amount of proteins produced when skin cells differentiate. These results were obtained both on cultured skin cells and on a reconstituted epidermis. K6PC-4, K6PC-5, and K6PC-9 may be used to treat skin diseases arising from abnormal growth of skin cells, the scientists concluded.
Article: "Novel synthetic ceramide derivatives increase intracellular calcium levels and promote epidermal keratinocyte differentiation," by Yoo Bin Kwon, Chang Deok Kim, Jong-Kyung Youm, Hyung Sub Gwak, Byeong Deog Park, Seung Hun Lee, Saewha Jeon, Bo Joong Kim, Young-Joon Seo, Jang-Kyu Park, and Jeung-Hoon Lee
The American Society for Biochemistry and Molecular Biology is a nonprofit scientific and educational organization with over 11,900 members in the United States and internationally. Most members teach and conduct research at colleges and universities. Others conduct research in various government laboratories, nonprofit research institutions and industry. The Society's student members attend undergraduate or graduate institutions.
Founded in 1906, the Society is based in Bethesda, Maryland, on the campus of the Federation of American Societies for Experimental Biology. The Society's purpose is to advance the science of biochemistry and molecular biology through publication of the Journal of Biological Chemistry, the Journal of Lipid Research, and Molecular and Cellular Proteomics, organization of scientific meetings, advocacy for funding of basic research and education, support of science education at all levels, and promoting the diversity of individuals entering the scientific work force.
For more information about ASBMB, see the Society's Web site at asbmb.
пятница, 10 июня 2011 г.
Going To Great Lengths For Beautiful Hair? Dermatologist Shares Hair Care Tips For Healthy And Damaged Hair
While the latest hairstyles and hair colors may look great, dermatologists warn that many women are subjecting their hair to harsh chemicals and heated styling devices that, in turn, can damage the hair. Over time, lustrous hair can look lackluster, become brittle and require a complete hair care overhaul to improve hair health and appearance.
Speaking today at the 69th Annual Meeting of the American Academy of Dermatology (Academy), dermatologist Zoe D. Draelos, MD, FAAD, consulting professor at Duke University School of Medicine, Durham, N.C., discussed the most common sources of hair damage and tips to reverse damage and maintain healthy, lustrous hair.
"One of the most common misconceptions about hair is that it is alive, when in fact hair is nonliving and does not heal itself once it is injured," said Dr. Draelos. "For this reason, once the hair is damaged it cannot heal itself except through new hair growth at the scalp. Women need to understand that the very things that they do to hair to make it appear beautiful, such as using hair dyes, perms and products that straighten the hair, will eventually end up damaging the hair's structure and ultimately affect its appearance."
Getting to the Root of Chemical Hair Damage
When hair is damaged, the protective lipid layer of fat on the outside of the cuticle - responsible for making the hair shiny - is removed. Chemical damage is one of the most common culprits of hair damage, as processed hair loses its natural moisturizers. The result is dried-out, frizzy hair that does not hold its style and accounts for the hair's dull appearance.
"Many products have been developed to counter the effects of over-processed hair, and regular moisturizing is a must for women with visible signs of hair damage," said Dr. Draelos.
Dr. Draelos offered these tips to combat chemical damage:
- Use conditioning shampoos and conditioners regularly to improve the appearance of frizzy hair. 2-in-1 shampoos that remove oil from the scalp, clean the hair, then condition the hair in the rinse phase also are good choices.
- Look for products containing dimethicone, which is available in shampoos, conditioners, sprays and creams. This ingredient has been shown to decrease static electricity, increase shine and improve manageability.
- Try newly introduced hair serums, which are applied by a few drops on the hands and rubbed through the length of the hair (but should not be applied directly to the scalp).
- Stop dyeing your hair and opt for hair's natural hair color instead.
- If you must dye your hair, stay "on shade" - or dye the hair within three color shades of its natural color. Dyeing hair darker, rather than lighter, also is generally better.
When the Heat is On, Hair Needs Some Time Off
Heat damage is another common source of hair damage, which produces a condition known as bubble hair. This occurs when the water in the hair, which makes the hair flexible, gets heated and turns into steam. Hair bubbles then occur on the hair shaft, creating a loss of cuticle. Signs of this form of hair damage include hair that smells burned, frizzy ends and hair that breaks easily.
"Dramatic temperature changes are hard on hair, and heat can, in a sense, cook the hair," said Dr. Draelos. "Think of hair like a piece of steak - it starts out nice and soft and flexible. But when you cook it, the steak changes texture and becomes hard. Similarly, hair transforms when exposed to heat over time, resulting in brittle hair that breaks easily. Protecting hair from too much heat is essential to maintaining healthy hair."
Hair damaged by heat cannot be repaired, as the affected hair will need to be cut off and allowed to regrow as healthy hair.
Dr. Draelos offered these tips for heat damaged hair:
- Allow hair to air dry, when possible.
- When using a hairdryer, do not use the highest heat setting immediately. Start out on the lowest heat setting first, then gradually increase heat.
- To straighten hair with a ceramic iron, put a moist towel in the device to protect the hair from direct heat.
- Look for temperature-controlled devices to control the amount of direct heat to hair.
- Moisturizing the hair regularly will help the appearance of heat damaged hair to some degree, but stopping the source of heat damage is essential.
Straightening Hair Comes at a Price
While ceramic flat irons are quite popular with women seeking sleek, straight hair, another procedure that uses chemicals in combination with heat to straighten or rearrange the hair's natural bonds is known as keratin hair straightening. Typically performed in salons, keratin hair straightening uses gluteraldehyde or formeldahyde rather than lye - a stronger bond breaker also used for hair straightening but which is even more damaging - combed through the hair to make it straight.
After one of the chemical solutions is applied to the hair, a keratin protein conditioner is put on the hair to make it less brittle. With this procedure, hair must be kept dry and not bent or manipulated for several days after the process.
For women considering keratin hair straightening, Dr. Draelos offered these suggestions:
- Avoid this procedure if you have tightly kinked hair, as it will not work in rearranging the natural hair bonds.
- To minimize hair damage and loss, extend the time between treatments.
- When washing hair, use a generous amount of conditioner to make hair less brittle.
- If hair becomes frizzy and brittle, stop the procedure and let new hair growth replace damaged hair.
TLC for Healthy Hair
To keep healthy hair looking its best, Dr. Draelos also provided the following tips:
- The less you do to your hair, the better. Avoid over-styling or processing hair.
- Be sure to wash the scalp, which is where the oil is, and then let shampoo run through the hair. Shampoo is meant to clean the scalp primarily and can damage the hair if overused.
- Let how oily your scalp is determine how often you wash your hair. If your scalp is oily, wash hair more frequently than if the scalp was drier.
- Conditioner should be used on the ends of the hair, not on the scalp, for best results.
- Pick a shampoo and conditioner based on your hair shape, such as curly or straight, and your hair condition, such as damaged, fine, or frizzy. These products don't need to be expensive to work well for your hair.
- Wear a hat to protect hair from ultraviolet (UV) radiation.
"It is best to choose a hairstyle closest to your hair's natural structure and color as possible, which will minimize hair damage," added Dr. Draelos. "Be sure to consult your dermatologist for any questions about styling products, concerns about the appearance of your hair, or unexplained hair loss."
Speaking today at the 69th Annual Meeting of the American Academy of Dermatology (Academy), dermatologist Zoe D. Draelos, MD, FAAD, consulting professor at Duke University School of Medicine, Durham, N.C., discussed the most common sources of hair damage and tips to reverse damage and maintain healthy, lustrous hair.
"One of the most common misconceptions about hair is that it is alive, when in fact hair is nonliving and does not heal itself once it is injured," said Dr. Draelos. "For this reason, once the hair is damaged it cannot heal itself except through new hair growth at the scalp. Women need to understand that the very things that they do to hair to make it appear beautiful, such as using hair dyes, perms and products that straighten the hair, will eventually end up damaging the hair's structure and ultimately affect its appearance."
Getting to the Root of Chemical Hair Damage
When hair is damaged, the protective lipid layer of fat on the outside of the cuticle - responsible for making the hair shiny - is removed. Chemical damage is one of the most common culprits of hair damage, as processed hair loses its natural moisturizers. The result is dried-out, frizzy hair that does not hold its style and accounts for the hair's dull appearance.
"Many products have been developed to counter the effects of over-processed hair, and regular moisturizing is a must for women with visible signs of hair damage," said Dr. Draelos.
Dr. Draelos offered these tips to combat chemical damage:
- Use conditioning shampoos and conditioners regularly to improve the appearance of frizzy hair. 2-in-1 shampoos that remove oil from the scalp, clean the hair, then condition the hair in the rinse phase also are good choices.
- Look for products containing dimethicone, which is available in shampoos, conditioners, sprays and creams. This ingredient has been shown to decrease static electricity, increase shine and improve manageability.
- Try newly introduced hair serums, which are applied by a few drops on the hands and rubbed through the length of the hair (but should not be applied directly to the scalp).
- Stop dyeing your hair and opt for hair's natural hair color instead.
- If you must dye your hair, stay "on shade" - or dye the hair within three color shades of its natural color. Dyeing hair darker, rather than lighter, also is generally better.
When the Heat is On, Hair Needs Some Time Off
Heat damage is another common source of hair damage, which produces a condition known as bubble hair. This occurs when the water in the hair, which makes the hair flexible, gets heated and turns into steam. Hair bubbles then occur on the hair shaft, creating a loss of cuticle. Signs of this form of hair damage include hair that smells burned, frizzy ends and hair that breaks easily.
"Dramatic temperature changes are hard on hair, and heat can, in a sense, cook the hair," said Dr. Draelos. "Think of hair like a piece of steak - it starts out nice and soft and flexible. But when you cook it, the steak changes texture and becomes hard. Similarly, hair transforms when exposed to heat over time, resulting in brittle hair that breaks easily. Protecting hair from too much heat is essential to maintaining healthy hair."
Hair damaged by heat cannot be repaired, as the affected hair will need to be cut off and allowed to regrow as healthy hair.
Dr. Draelos offered these tips for heat damaged hair:
- Allow hair to air dry, when possible.
- When using a hairdryer, do not use the highest heat setting immediately. Start out on the lowest heat setting first, then gradually increase heat.
- To straighten hair with a ceramic iron, put a moist towel in the device to protect the hair from direct heat.
- Look for temperature-controlled devices to control the amount of direct heat to hair.
- Moisturizing the hair regularly will help the appearance of heat damaged hair to some degree, but stopping the source of heat damage is essential.
Straightening Hair Comes at a Price
While ceramic flat irons are quite popular with women seeking sleek, straight hair, another procedure that uses chemicals in combination with heat to straighten or rearrange the hair's natural bonds is known as keratin hair straightening. Typically performed in salons, keratin hair straightening uses gluteraldehyde or formeldahyde rather than lye - a stronger bond breaker also used for hair straightening but which is even more damaging - combed through the hair to make it straight.
After one of the chemical solutions is applied to the hair, a keratin protein conditioner is put on the hair to make it less brittle. With this procedure, hair must be kept dry and not bent or manipulated for several days after the process.
For women considering keratin hair straightening, Dr. Draelos offered these suggestions:
- Avoid this procedure if you have tightly kinked hair, as it will not work in rearranging the natural hair bonds.
- To minimize hair damage and loss, extend the time between treatments.
- When washing hair, use a generous amount of conditioner to make hair less brittle.
- If hair becomes frizzy and brittle, stop the procedure and let new hair growth replace damaged hair.
TLC for Healthy Hair
To keep healthy hair looking its best, Dr. Draelos also provided the following tips:
- The less you do to your hair, the better. Avoid over-styling or processing hair.
- Be sure to wash the scalp, which is where the oil is, and then let shampoo run through the hair. Shampoo is meant to clean the scalp primarily and can damage the hair if overused.
- Let how oily your scalp is determine how often you wash your hair. If your scalp is oily, wash hair more frequently than if the scalp was drier.
- Conditioner should be used on the ends of the hair, not on the scalp, for best results.
- Pick a shampoo and conditioner based on your hair shape, such as curly or straight, and your hair condition, such as damaged, fine, or frizzy. These products don't need to be expensive to work well for your hair.
- Wear a hat to protect hair from ultraviolet (UV) radiation.
"It is best to choose a hairstyle closest to your hair's natural structure and color as possible, which will minimize hair damage," added Dr. Draelos. "Be sure to consult your dermatologist for any questions about styling products, concerns about the appearance of your hair, or unexplained hair loss."
четверг, 9 июня 2011 г.
What Is Scleroderma? What Causes Scleroderma?
Scleroderma refers to a group of rare chronic autoimmune diseases in which the skin and connective tissues tighten and harden; it is a progressive disease. The skin and connective tissues are fibers that make up the framework that supports the body.
Although scleroderma may run in families, it often occurs in patients without any family history of the disease. Genes linked to scleroderma have not been identified. You cannot catch scleroderma from somebody who has it - it is not contagious. According to experts, approximately 1 in every 4,000 people has some form of scleroderma. It is rare in children, and is more common in females than males. It generally develops when the patient is aged between 30 and 60 years.
There are two major forms of scleroderma:
Limited cutaneous scleroderma (morphea) - the patient's hands, arms and face are usually affected. Pulmonary hypertension is also common.
Diffuse cutaneous scleroderma (systemic sclerosis) - a rapidly progressing disease that affects a much larger area of the skin and at least one internal organ, often the kidneys, esophagus, heart and lungs. Diffuse cutaneous scleroderma can be fatal.
Although no specific treatment for scleroderma exists, there is treatment for organ system complications.
Prognosis for limited cutaneous scleroderma is usually good. It is worse for diffuse cutaneous scleroderma, especially for elderly male patients. Pulmonary, heart and/or kidney complications are the most common causes of death.
According to Medilexicon's medical dictionary:
Scleroderma means "Thickening and induration of the skin caused by new collagen formation, with atrophy of pilosebaceous follicles; either a manifestation of progressive systemic sclerosis or localized (morphea)."
What are the signs and symptoms of scleroderma?
A symptom is something the patient feels and reports, while a sign is something other people, such as the doctor detect. For example, pain may be a symptom while a rash may be a sign.
The signs and symptoms of scleroderma vary according to which organ systems are affected. Diagnosis may initially be hard to make because early symptoms are commonly found in the general population - symptoms which are not necessarily linked to the disease. The most common signs and symptoms include:
Raynaud's phenomenon - an over-reaction to cold temperatures or emotional distress. The small blood vessels in the hands and feet narrow, resulting in numbness, pain and color changes in the toes and fingers.
GERD (gastroesophageal reflux disease) - the patient may experience acid reflux. If the intestinal muscles are not moving food through the intestines properly there may be problems absorbing nutrients.
Skin - the individual may have swollen hands and fingers, patches of hardened skin (especially fingers), tight skin around the face, mouth or hands. The skin may seem to shine because of the tightness. Affected areas may have restricted movement.
Localized scleroderma signs and symptoms:
Morphea - thickened, oval-shaped patches of skin; the shapes have a purple border and are white in the middle.
Linear scleroderma - bands/streaks of hardened skin on the limbs or forehead. One or more limbs may be affected.
Systemic scleroderma (systemic sclerosis) - blood vessels and internal organs are also affected (as well as the skin). The patient may experience fatigue (tiredness), weight loss and muscle pains.
What are the risk factors for scleroderma?
A risk factor is something which increases the likelihood of developing a condition or disease. For example, obesity significantly raises the risk of developing diabetes type 2. Therefore, obesity is a risk factor for diabetes type 2.
Choctaw Native Americans, from Oklahoma are 20 times more likely to develop scleroderma than other people. Choctaws living in Mississippi do not have this higher risk.
People of African descent - according to the Mayo Clinic, USA, African-Americans have a significantly higher risk of developing scleroderma than Americans of European descent. African-Americans with systemic scleroderma high a much higher chance of developing severe lung complications compared to other people with system scleroderma.
Gender - the incidence of scleroderma among females is four times higher than in males.
Environmental factors - miners who are exposed to silica dust, workers exposed to certain industrial solvents (e.g. paint thinners), as well as patients who are given certain chemotherapies have a higher risk of developing scleroderma.
What are the causes of scleroderma?
Scleroderma occurs when the body produces and accumulates too much collagen in tissues. Collagen is a fibrous type of protein which makes up the body's connective tissues (including skin).
Experts suspect that the body's immune system plays a role in the abnormal production of collagen. The individual's immune system attacks the body, resulting in inflammation and the production of too much collagen. Experts do not know what triggers this.
Diagnosing scleroderma
Scleroderma may be difficult to diagnose because it can develop gradually and present itself in several different forms. Experts say that there is no single test that can make a definitive diagnosis. The doctor needs to look at the whole person, taking into account signs and symptoms, the results of a physical examination and some tests. Diagnosis often requires the expertise of a rheumatologist, a doctor who specializes in joint and connective tissue diseases.
The following tests may be ordered:
Fingernails - a skin microscope is used to look at the tiny blood vessels (capillaries) in the nail area. Changes associated with systemic sclerosis may be detected.
Skin biopsy - a small sample of the affected skin is extracted and examined under a microscope.
Blood test - patients with scleroderma usually have high levels of certain antibodies.
Other tests - other tests to detect any lung, heart or gastrointestinal complications may also be ordered.
What are the treatment options for scleroderma?
There is currently no treatment that can cure scleroderma. No medication can halt the overproduction of collagen. The localized variety of scleroderma may resolve on its own. Some medications may help control scleroderma symptoms and also help prevent complications.
The doctor's aim will be to:
Relieve symptoms
Try to prevent the condition from progressing, or at least slow down its speed of progression
Detect and treat complications as soon as possible
Minimize possible disabilities
Medications
Dilating blood vessels - blood pressure medications that dilate the blood vessels may help prevent some organ problems (e.g. kidney or lung). They may also help treat Raynaud's disease.
Immune system - some medications, known as immunosuppressants, may suppress the immune system (calm it down). These are the same medications organ transplant recipients use to stop their immune systems from rejecting the new organ.
Therapy
Physical therapy (UK: physiotherapy) or occupational therapy - the patient may be helped to manage pain, improve mobility, gain more strength. Certain strategies may be learnt to help the patient perform essential daily tasks. An occupational therapist may advise on certain aids, such as splints, which support the joints and help the patient carry out daily tasks more successfully.
Skin appearance - exposure to ultraviolet light may help improve the appearance of certain skin lesions.
Dental checkups - if the patient has dry mouth symptoms regular dental checkups are essential.
Surgery
Amputation - if ulcers on the fingers have developed gangrene it may be necessary to amputate (more common with severe Raynaud's disease).
Lung transplant - if the patient has developed pulmonary hypertension (high blood pressure in the arteries to the lungs), a lung transplant may help.
Laser surgery may be used to help with tight skin, eliminate lesions, or camouflage them.
What are the possible complications of scleroderma?
Scleroderma complications may be mild, severe and even life-threatening.
Raynaud's complications - restricted blood flow may permanently damage the fingertips, resulting in pits or ulcers in the flesh. Gangrene can occur, leading to amputation.
Lung complications - pulmonary fibrosis (scarring of lung tissue) can lead to reduced lung function, making it harder to breathe properly. The patient may also develop pulmonary hypertension - high blood pressure in the pulmonary artery that conveys blood from the right ventricle (of the heart) to the lungs. The lungs can become permanently damaged, and there may be failure of the right ventricle.
Kidneys - kidney damage can result in hypertension (high blood pressure) and excess urine protein levels. In some cases there may be a sudden increase in blood pressure and rapid kidney failure (renal crisis) - symptoms include headache, vision problems, seizures, breathlessness, swelling of the legs and feet, or reduced urine production.
Heart - arrhythmias (abnormal heartbeats) and congestive heart failure may result from scarring of heart tissue. The patient may develop pericarditis - inflammation of the lining around the heart (the pericardium); this causes chest pain and fluid build-up around the heart (pericardial effusion).
Teeth - the facial skin may tighten so much that the mouth becomes smaller, making it harder to brush one's teeth; even having one's teeth professionally cleaned may be difficult. Dry mouth is common in patients with scleroderma - this increases the risk of tooth decay. Acid reflux may destroy tooth enamel. Changes in gum tissue may result in loose teeth (they may even fall out).
Sexual function - male erectile dysfunction is common. Women's vaginal opening may be constricting, making sexual function harder. Females with scleroderma may also experience decreased sexual lubrication.
Thyroid - the thyroid gland can become underactive (hypothyroidism).
Joints and muscles - if tight skin limits the movement of a joint, muscles and joints may become affected.
Intestines - the intestines may become underactive, resulting in bloating, constipation, and some other problems.
Although scleroderma may run in families, it often occurs in patients without any family history of the disease. Genes linked to scleroderma have not been identified. You cannot catch scleroderma from somebody who has it - it is not contagious. According to experts, approximately 1 in every 4,000 people has some form of scleroderma. It is rare in children, and is more common in females than males. It generally develops when the patient is aged between 30 and 60 years.
There are two major forms of scleroderma:
Limited cutaneous scleroderma (morphea) - the patient's hands, arms and face are usually affected. Pulmonary hypertension is also common.
Diffuse cutaneous scleroderma (systemic sclerosis) - a rapidly progressing disease that affects a much larger area of the skin and at least one internal organ, often the kidneys, esophagus, heart and lungs. Diffuse cutaneous scleroderma can be fatal.
Although no specific treatment for scleroderma exists, there is treatment for organ system complications.
Prognosis for limited cutaneous scleroderma is usually good. It is worse for diffuse cutaneous scleroderma, especially for elderly male patients. Pulmonary, heart and/or kidney complications are the most common causes of death.
According to Medilexicon's medical dictionary:
Scleroderma means "Thickening and induration of the skin caused by new collagen formation, with atrophy of pilosebaceous follicles; either a manifestation of progressive systemic sclerosis or localized (morphea)."
What are the signs and symptoms of scleroderma?
A symptom is something the patient feels and reports, while a sign is something other people, such as the doctor detect. For example, pain may be a symptom while a rash may be a sign.
The signs and symptoms of scleroderma vary according to which organ systems are affected. Diagnosis may initially be hard to make because early symptoms are commonly found in the general population - symptoms which are not necessarily linked to the disease. The most common signs and symptoms include:
Raynaud's phenomenon - an over-reaction to cold temperatures or emotional distress. The small blood vessels in the hands and feet narrow, resulting in numbness, pain and color changes in the toes and fingers.
GERD (gastroesophageal reflux disease) - the patient may experience acid reflux. If the intestinal muscles are not moving food through the intestines properly there may be problems absorbing nutrients.
Skin - the individual may have swollen hands and fingers, patches of hardened skin (especially fingers), tight skin around the face, mouth or hands. The skin may seem to shine because of the tightness. Affected areas may have restricted movement.
Localized scleroderma signs and symptoms:
Morphea - thickened, oval-shaped patches of skin; the shapes have a purple border and are white in the middle.
Linear scleroderma - bands/streaks of hardened skin on the limbs or forehead. One or more limbs may be affected.
Systemic scleroderma (systemic sclerosis) - blood vessels and internal organs are also affected (as well as the skin). The patient may experience fatigue (tiredness), weight loss and muscle pains.
What are the risk factors for scleroderma?
A risk factor is something which increases the likelihood of developing a condition or disease. For example, obesity significantly raises the risk of developing diabetes type 2. Therefore, obesity is a risk factor for diabetes type 2.
Choctaw Native Americans, from Oklahoma are 20 times more likely to develop scleroderma than other people. Choctaws living in Mississippi do not have this higher risk.
People of African descent - according to the Mayo Clinic, USA, African-Americans have a significantly higher risk of developing scleroderma than Americans of European descent. African-Americans with systemic scleroderma high a much higher chance of developing severe lung complications compared to other people with system scleroderma.
Gender - the incidence of scleroderma among females is four times higher than in males.
Environmental factors - miners who are exposed to silica dust, workers exposed to certain industrial solvents (e.g. paint thinners), as well as patients who are given certain chemotherapies have a higher risk of developing scleroderma.
What are the causes of scleroderma?
Scleroderma occurs when the body produces and accumulates too much collagen in tissues. Collagen is a fibrous type of protein which makes up the body's connective tissues (including skin).
Experts suspect that the body's immune system plays a role in the abnormal production of collagen. The individual's immune system attacks the body, resulting in inflammation and the production of too much collagen. Experts do not know what triggers this.
Diagnosing scleroderma
Scleroderma may be difficult to diagnose because it can develop gradually and present itself in several different forms. Experts say that there is no single test that can make a definitive diagnosis. The doctor needs to look at the whole person, taking into account signs and symptoms, the results of a physical examination and some tests. Diagnosis often requires the expertise of a rheumatologist, a doctor who specializes in joint and connective tissue diseases.
The following tests may be ordered:
Fingernails - a skin microscope is used to look at the tiny blood vessels (capillaries) in the nail area. Changes associated with systemic sclerosis may be detected.
Skin biopsy - a small sample of the affected skin is extracted and examined under a microscope.
Blood test - patients with scleroderma usually have high levels of certain antibodies.
Other tests - other tests to detect any lung, heart or gastrointestinal complications may also be ordered.
What are the treatment options for scleroderma?
There is currently no treatment that can cure scleroderma. No medication can halt the overproduction of collagen. The localized variety of scleroderma may resolve on its own. Some medications may help control scleroderma symptoms and also help prevent complications.
The doctor's aim will be to:
Relieve symptoms
Try to prevent the condition from progressing, or at least slow down its speed of progression
Detect and treat complications as soon as possible
Minimize possible disabilities
Medications
Dilating blood vessels - blood pressure medications that dilate the blood vessels may help prevent some organ problems (e.g. kidney or lung). They may also help treat Raynaud's disease.
Immune system - some medications, known as immunosuppressants, may suppress the immune system (calm it down). These are the same medications organ transplant recipients use to stop their immune systems from rejecting the new organ.
Therapy
Physical therapy (UK: physiotherapy) or occupational therapy - the patient may be helped to manage pain, improve mobility, gain more strength. Certain strategies may be learnt to help the patient perform essential daily tasks. An occupational therapist may advise on certain aids, such as splints, which support the joints and help the patient carry out daily tasks more successfully.
Skin appearance - exposure to ultraviolet light may help improve the appearance of certain skin lesions.
Dental checkups - if the patient has dry mouth symptoms regular dental checkups are essential.
Surgery
Amputation - if ulcers on the fingers have developed gangrene it may be necessary to amputate (more common with severe Raynaud's disease).
Lung transplant - if the patient has developed pulmonary hypertension (high blood pressure in the arteries to the lungs), a lung transplant may help.
Laser surgery may be used to help with tight skin, eliminate lesions, or camouflage them.
What are the possible complications of scleroderma?
Scleroderma complications may be mild, severe and even life-threatening.
Raynaud's complications - restricted blood flow may permanently damage the fingertips, resulting in pits or ulcers in the flesh. Gangrene can occur, leading to amputation.
Lung complications - pulmonary fibrosis (scarring of lung tissue) can lead to reduced lung function, making it harder to breathe properly. The patient may also develop pulmonary hypertension - high blood pressure in the pulmonary artery that conveys blood from the right ventricle (of the heart) to the lungs. The lungs can become permanently damaged, and there may be failure of the right ventricle.
Kidneys - kidney damage can result in hypertension (high blood pressure) and excess urine protein levels. In some cases there may be a sudden increase in blood pressure and rapid kidney failure (renal crisis) - symptoms include headache, vision problems, seizures, breathlessness, swelling of the legs and feet, or reduced urine production.
Heart - arrhythmias (abnormal heartbeats) and congestive heart failure may result from scarring of heart tissue. The patient may develop pericarditis - inflammation of the lining around the heart (the pericardium); this causes chest pain and fluid build-up around the heart (pericardial effusion).
Teeth - the facial skin may tighten so much that the mouth becomes smaller, making it harder to brush one's teeth; even having one's teeth professionally cleaned may be difficult. Dry mouth is common in patients with scleroderma - this increases the risk of tooth decay. Acid reflux may destroy tooth enamel. Changes in gum tissue may result in loose teeth (they may even fall out).
Sexual function - male erectile dysfunction is common. Women's vaginal opening may be constricting, making sexual function harder. Females with scleroderma may also experience decreased sexual lubrication.
Thyroid - the thyroid gland can become underactive (hypothyroidism).
Joints and muscles - if tight skin limits the movement of a joint, muscles and joints may become affected.
Intestines - the intestines may become underactive, resulting in bloating, constipation, and some other problems.
среда, 8 июня 2011 г.
New Type Of Botulinum Toxin Appears To Be Well Tolerated And May Help Reduce Forehead Wrinkles
Injections with a new type of botulinum toxin appears to be well tolerated and may help to improve the appearance of moderate to severe forehead lines with no evidence of diminishing treatment response over 13 months, according to a report in the March/April issue of Archives of Facial Plastic Surgery, one of the JAMA/Archives journals.
Injecting low doses of Clostridium botulinum toxin type A is a generally accepted method for treating lines on the face, according to background information in the article. A new botulinum toxin type A (Reloxin) has been used to treat neurological disorders outside the United States for more than 15 years and is approved to treat wrinkles in 23 countries. In the United States, this product has been under investigation for the treatment of glabellar or forehead lines since 2002, according to the authors.
Ronald Moy, M.D., of the Moy-Fincher Medical Group, Los Angeles, and colleagues report data from a phase 3, open-label study of 1,200 patients. Investigators injected 0.05 milliliters of solution, each containing 10 units of the new botulinum toxin, into each of five injection sites in the forehead at the beginning of each treatment cycle. Patients maintained diaries of treatment effects, were telephoned seven days later to check for adverse events and were re-examined clinically after two weeks, 30 days and again every month until their next treatment, withdrawal from the study or the end of the study. Based on patient response, as many as five consecutive treatments were given with a minimum of 85 days in between.
A total of 1,052 patients completed the 13-month study. During the study period, 2,838 adverse events were experienced by 880 patients. Of those, 804 (28 percent) were considered probably or possibly related to the treatment, including events at the injection site (18 percent), nervous system disorders (14 percent) such as headache (12 percent) and eye events (9 percent, including 4 percent with ptosis, drooping of the eyelid or brow). Only one patient discontinued the study because of adverse events.
The authors suggest that based on investigators' and patients' assessments, the onset of effect and the duration of effect, the new botulinum toxin type A demonstrated benefits that did not diminish with repeat treatments. "The onset of effect was seen as soon as 24 hours and at a median [midpoint] of three days during all cycles," they write. By day seven of each treatment cycle, 93 percent to 95 percent of patients reported a response to treatment, and between 80 percent and 91 percent had a response by day 30 based on the investigators' assessments.
The authors conclude that multiple cycles of treatment with 50 units of the new botulinum type A toxin were well tolerated and maintained a clinical effect over 13 months and that the incidence of treatment-emergent adverse events decreased over time, showing no evidence of cumulative safety issues after more than 4,000 treatments with this product.
Arch Facial Plast Surg. 2009;11[2]:77-83.
Injecting low doses of Clostridium botulinum toxin type A is a generally accepted method for treating lines on the face, according to background information in the article. A new botulinum toxin type A (Reloxin) has been used to treat neurological disorders outside the United States for more than 15 years and is approved to treat wrinkles in 23 countries. In the United States, this product has been under investigation for the treatment of glabellar or forehead lines since 2002, according to the authors.
Ronald Moy, M.D., of the Moy-Fincher Medical Group, Los Angeles, and colleagues report data from a phase 3, open-label study of 1,200 patients. Investigators injected 0.05 milliliters of solution, each containing 10 units of the new botulinum toxin, into each of five injection sites in the forehead at the beginning of each treatment cycle. Patients maintained diaries of treatment effects, were telephoned seven days later to check for adverse events and were re-examined clinically after two weeks, 30 days and again every month until their next treatment, withdrawal from the study or the end of the study. Based on patient response, as many as five consecutive treatments were given with a minimum of 85 days in between.
A total of 1,052 patients completed the 13-month study. During the study period, 2,838 adverse events were experienced by 880 patients. Of those, 804 (28 percent) were considered probably or possibly related to the treatment, including events at the injection site (18 percent), nervous system disorders (14 percent) such as headache (12 percent) and eye events (9 percent, including 4 percent with ptosis, drooping of the eyelid or brow). Only one patient discontinued the study because of adverse events.
The authors suggest that based on investigators' and patients' assessments, the onset of effect and the duration of effect, the new botulinum toxin type A demonstrated benefits that did not diminish with repeat treatments. "The onset of effect was seen as soon as 24 hours and at a median [midpoint] of three days during all cycles," they write. By day seven of each treatment cycle, 93 percent to 95 percent of patients reported a response to treatment, and between 80 percent and 91 percent had a response by day 30 based on the investigators' assessments.
The authors conclude that multiple cycles of treatment with 50 units of the new botulinum type A toxin were well tolerated and maintained a clinical effect over 13 months and that the incidence of treatment-emergent adverse events decreased over time, showing no evidence of cumulative safety issues after more than 4,000 treatments with this product.
Arch Facial Plast Surg. 2009;11[2]:77-83.
вторник, 7 июня 2011 г.
Cutanea Announces Promising Phase II Results In Rosacea With Omiganan
Cutanea Life Sciences, an
emerging specialty pharmaceutical company focused on improving human health
and appearance through the development and commercialization of treatments
for diseased and aging skin conditions, announced results from its
completed Phase II clinical trial of Omiganan.
The trial compared Omiganan 2.5% and 1% topical gel to vehicle in
subjects with papulopustular rosacea. Study results demonstrated that the
formulation was safe and well-tolerated at all doses tested. Among the
once-daily treatment arms, a dose-dependent response was observed in both
lesion reductions and Treatment Success, as defined by Investigator Global
Assessment (IGA) scores. After nine weeks of treatment, once-daily (QD)
Omiganan 2.5% gel showed superior lesion count reductions and Treatment
Success, compared to 1% Omiganan QD and vehicle. Omiganan provided greater
improvements compared to vehicle among patients with a more severe
condition at Baseline (more numerous inflammatory lesions). Lesion counts
continued to drop at all evaluations over the duration of the study,
indicating that further improvements may be expected with a duration of
treatment exceeding nine weeks. Twice daily (BID) application of 2.5%
Omiganan did not demonstrate substantial improvement in lesion reduction or
the number of patients reaching Treatment Success compared to once daily
application. Based on the results from this study, Cutanea has selected a
once-daily dose of Omiganan 2.5% for further development for the treatment
of papulopustular rosacea.
Dr. Guy Webster, Founding and Current President of the American Acne &
Rosacea Society and Clinical Professor of Dermatology at Jefferson Medical
College stated, "Topical Omiganan is a novel approach, actually the first
in a new class of dermatologic drugs, for the treatment of rosacea. Initial
results are promising and I look forward to a more precise estimation of
the effectiveness of the drug in the larger Phase III program."
The objective of this exploratory Phase II study was to find the
optimal dose and regimen of Omiganan for further study as a treatment for
rosacea. The trial enrolled 240 patients with papulopustular rosacea and
Investigator Global Assessment (IGA) scores of grade 3 or 4 (moderate to
severe disease). Patients were randomized into one of five treatment groups
in a 2:2:2:1:1 ratio: Omiganan 1% QD, Omiganan 2.5% QD, Omiganan 2.5%
twice-daily (BID), Vehicle QD, or Vehicle BID. During the total nine-week
treatment period, safety and efficacy assessments were performed at weeks
one, three, six, and nine.
The primary efficacy endpoint was mean percent reduction in the number
of inflammatory lesions from Baseline to Week 9. Patients receiving
once-daily Omiganan 2.5% showed a mean 31% reduction in the number of
inflammatory facial lesions compared to a 14% reduction in patients
receiving once-daily vehicle. And, among rosacea patients with 18 or more
lesions at Baseline, the mean reduction for once-daily Omiganan 2.5% was
40%, compared to an 11% lesion increase in the once-daily vehicle group.
Secondary endpoints included the absolute change from Baseline in the
number of inflammatory lesions at Week nine and at each interim visit, the
percent change in number of inflammatory lesions at interim visits, the
absolute change from Baseline in IGA score and other signs and symptoms of
rosacea at Week nine and each interim visit, and Treatment Success at Week
nine and each interim visit.
Although a statistically significant difference between active and
vehicle was not achieved for the primary endpoint, this study demonstrated
that in both the intent-to-treat and the per protocol populations, Omiganan
2.5% QD was statistically significantly better than vehicle QD at Week nine
in the absolute change of inflammatory lesions (p=0.041 for
intent-to-treat, and p=0.012 for per protocol populations). While in this
exploratory study this endpoint was identified as a secondary end point,
FDA currently requires the absolute change (rather than percent change) in
the number of inflammatory lesions as one of the co-primary endpoints,
along with Treatment Success, for demonstrating efficacy in a Phase III
trial in rosacea.
"Based on these encouraging results, we have selected once-daily
Omiganan 2.5% for further study in rosacea, which is a critical step
towards potential commercialization, either directly or in collaboration
with a partner," commented Robert J. Bitterman, President and CEO of
Cutanea.
About Rosacea
Rosacea is a chronic dermatologic disorder with no current cure and a
poorly understood etiology that afflicts an estimated 14 million Americans.
Symptoms primarily manifest on the facial skin and include facial flushing,
central facial inflammatory lesions, and facial erythema. According to
surveys conducted by the National Rosacea Society (NRS), nearly 70% of
rosacea patients said the disorder had lowered their self-confidence and
self-esteem; 41% reported it had caused them to avoid public contact or
cancel social engagements; and nearly 30% claimed to have missed work due
to rosacea. Of these rosacea patients surveyed by the NRS that sought
medical treatment, over 70 percent reported an improvement in their
emotional and social well-being.
Typical onset of rosacea occurs between 30 and 50 years of age and is
more prevalent in women than men. Clearing up the initial outbreak is only
the beginning, as rosacea is characterized by periods of relapses and
remissions. Relapse episodes can be spurred by sun exposure, stress, hot or
cold weather, alcohol, spicy foods, exercise, and certain skin care
products and medications.
Absent a cure for rosacea, treatment is aimed at alleviating the
disorder's symptoms. Topical or oral medications are generally prescribed
for mild to moderate papulopustular Rosacea, while oral medications are
prescribed for severe disease. Current oral antibiotic therapies may
alleviate symptoms of rosacea, but may present an issue with undesirable
side effects). While there are other topical products currently available
on the market, there is an opportunity to improve the existing irritation
profile for these treatments.
About Omiganan
Cutanea Life Sciences licensed the exclusive worldwide rights for
dermatological uses to a novel, cationic, antimicrobial peptide, whose
active component is omiganan pentahydrochloride from Migenix Inc., a
British Columbia Corporation located in Vancouver, BC, Canada (TSX: MGI;
OTC: MGIFF). Omiganan is in development as a topical treatment for
papulopustular rosacea and may prevent the inflammatory cascade that is
theorized to lead to the signs and symptoms of rosacea. Omiganan topical
gel has been evaluated in early stage clinical trials at concentrations of
0.5% and 3.0%, and early and late stage trials at 1.0%. At each of these
concentrations and in all trials conducted, omiganan was found to be safe,
well tolerated and non-irritating with no evidence of systemic absorption.
While cationic antimicrobial peptides, such as Omiganan, are well known for
their antimicrobial properties, recent research has shown that they also
may play a role in the inflammatory response. Omiganan, in in vitro assays,
demonstrated a rapid bactericidal activity against microorganisms that
colonize the skin and that may play a role in the pathogenesis of
inflammatory lesions.
About Cutanea
Cutanea Life Sciences is an emerging specialty pharmaceutical company
focused on improving human health and appearance through the development
and commercialization of treatments for diseased and aging skin conditions.
The Company strives to maximize value through flawless execution of
strategically designed programs. Its core strategy is to in-license novel,
patented, mid- stage treatment candidates for aggressive development as
potential market- leading dermatologic treatments for commercialization or
out-license. The Company focuses on leveraging each of its products to
address a variety of indications that serve the collective interest of
patients and medical professionals.
Cutanea Life Science's core competencies include a team of
professionals with more than 90 years of combined experience in developing
and commercializing healthcare products. In addition to the core team,
Cutanea is advised by a broad network of technical and commercial experts,
as well as practicing physicians and key medical opinion leaders.
Cutanea Life Sciences is a member of the family of bio/pharmaceutical
companies founded in conjunction with Paramount BioSciences, LLC.
CAUTION CONCERNING FORWARD LOOKING STATEMENTS:
This press release contains certain forward-looking information that is
intended to be covered by the safe harbor for "forward-looking statements"
provided by the Private Securities Litigation Reform Act of 1995. Forward-
looking statements are statements that are not historical facts. Words such
as "expect(s)," "feel(s)," "believe(s)," "will," "may," "anticipate(s)" and
similar expressions are intended to identify forward-looking statements.
These statements include, but are not limited to, financial projections and
estimates and their underlying assumptions; statements regarding plans,
objectives and expectations with respect to future operations, products and
services; and statements regarding future performance. Such statements are
subject to certain risks and uncertainties, many of which are difficult to
predict and generally beyond the control of Cutanea Life Sciences that
could cause actual results to differ materially from those expressed in, or
implied or projected by, the forward-looking information and statements.
These risks and uncertainties include: those generally associated with
developmental stage biopharmaceutical companies; the progress or likelihood
of success of our product research and development programs; the status of
our preclinical and clinical development of potential drugs; the likelihood
of success of our drug products in clinical trials and the regulatory
approval process; our drug products' efficacy, abuse and tamper resistance,
onset and duration of drug action, ability to provide protection from
overdose, ability to reduce the development of tolerance, ability to
improve symptomatology or otherwise improve patients' symptoms; the
incidence of adverse events; the ability to develop, manufacture, launch
and market our drug products; our projections for future revenues,
profitability and ability to achieve certain sales targets; our estimates
regarding our capital requirements and our needs for additional financing;
the likelihood of obtaining favorable scheduling and labeling of our drug
products; the likelihood of regulatory approval under Section 505(b)(2) and
other applicable Sections under the Federal Food, Drug, and Cosmetic Act;
our ability to develop safer and improved versions of widely- prescribed
drugs using our technology; and our ability to obtain favorable patent
claims. Readers are cautioned not to place undue reliance on these
forward-looking statements that speak only as of the date hereof. Cutanea
Life Sciences does not undertake any obligation to republish revised
forward- looking statements to reflect events or circumstances after the
date hereof or to reflect the occurrence of unanticipated events.
Cutanea Life Sciences
cutanealife
emerging specialty pharmaceutical company focused on improving human health
and appearance through the development and commercialization of treatments
for diseased and aging skin conditions, announced results from its
completed Phase II clinical trial of Omiganan.
The trial compared Omiganan 2.5% and 1% topical gel to vehicle in
subjects with papulopustular rosacea. Study results demonstrated that the
formulation was safe and well-tolerated at all doses tested. Among the
once-daily treatment arms, a dose-dependent response was observed in both
lesion reductions and Treatment Success, as defined by Investigator Global
Assessment (IGA) scores. After nine weeks of treatment, once-daily (QD)
Omiganan 2.5% gel showed superior lesion count reductions and Treatment
Success, compared to 1% Omiganan QD and vehicle. Omiganan provided greater
improvements compared to vehicle among patients with a more severe
condition at Baseline (more numerous inflammatory lesions). Lesion counts
continued to drop at all evaluations over the duration of the study,
indicating that further improvements may be expected with a duration of
treatment exceeding nine weeks. Twice daily (BID) application of 2.5%
Omiganan did not demonstrate substantial improvement in lesion reduction or
the number of patients reaching Treatment Success compared to once daily
application. Based on the results from this study, Cutanea has selected a
once-daily dose of Omiganan 2.5% for further development for the treatment
of papulopustular rosacea.
Dr. Guy Webster, Founding and Current President of the American Acne &
Rosacea Society and Clinical Professor of Dermatology at Jefferson Medical
College stated, "Topical Omiganan is a novel approach, actually the first
in a new class of dermatologic drugs, for the treatment of rosacea. Initial
results are promising and I look forward to a more precise estimation of
the effectiveness of the drug in the larger Phase III program."
The objective of this exploratory Phase II study was to find the
optimal dose and regimen of Omiganan for further study as a treatment for
rosacea. The trial enrolled 240 patients with papulopustular rosacea and
Investigator Global Assessment (IGA) scores of grade 3 or 4 (moderate to
severe disease). Patients were randomized into one of five treatment groups
in a 2:2:2:1:1 ratio: Omiganan 1% QD, Omiganan 2.5% QD, Omiganan 2.5%
twice-daily (BID), Vehicle QD, or Vehicle BID. During the total nine-week
treatment period, safety and efficacy assessments were performed at weeks
one, three, six, and nine.
The primary efficacy endpoint was mean percent reduction in the number
of inflammatory lesions from Baseline to Week 9. Patients receiving
once-daily Omiganan 2.5% showed a mean 31% reduction in the number of
inflammatory facial lesions compared to a 14% reduction in patients
receiving once-daily vehicle. And, among rosacea patients with 18 or more
lesions at Baseline, the mean reduction for once-daily Omiganan 2.5% was
40%, compared to an 11% lesion increase in the once-daily vehicle group.
Secondary endpoints included the absolute change from Baseline in the
number of inflammatory lesions at Week nine and at each interim visit, the
percent change in number of inflammatory lesions at interim visits, the
absolute change from Baseline in IGA score and other signs and symptoms of
rosacea at Week nine and each interim visit, and Treatment Success at Week
nine and each interim visit.
Although a statistically significant difference between active and
vehicle was not achieved for the primary endpoint, this study demonstrated
that in both the intent-to-treat and the per protocol populations, Omiganan
2.5% QD was statistically significantly better than vehicle QD at Week nine
in the absolute change of inflammatory lesions (p=0.041 for
intent-to-treat, and p=0.012 for per protocol populations). While in this
exploratory study this endpoint was identified as a secondary end point,
FDA currently requires the absolute change (rather than percent change) in
the number of inflammatory lesions as one of the co-primary endpoints,
along with Treatment Success, for demonstrating efficacy in a Phase III
trial in rosacea.
"Based on these encouraging results, we have selected once-daily
Omiganan 2.5% for further study in rosacea, which is a critical step
towards potential commercialization, either directly or in collaboration
with a partner," commented Robert J. Bitterman, President and CEO of
Cutanea.
About Rosacea
Rosacea is a chronic dermatologic disorder with no current cure and a
poorly understood etiology that afflicts an estimated 14 million Americans.
Symptoms primarily manifest on the facial skin and include facial flushing,
central facial inflammatory lesions, and facial erythema. According to
surveys conducted by the National Rosacea Society (NRS), nearly 70% of
rosacea patients said the disorder had lowered their self-confidence and
self-esteem; 41% reported it had caused them to avoid public contact or
cancel social engagements; and nearly 30% claimed to have missed work due
to rosacea. Of these rosacea patients surveyed by the NRS that sought
medical treatment, over 70 percent reported an improvement in their
emotional and social well-being.
Typical onset of rosacea occurs between 30 and 50 years of age and is
more prevalent in women than men. Clearing up the initial outbreak is only
the beginning, as rosacea is characterized by periods of relapses and
remissions. Relapse episodes can be spurred by sun exposure, stress, hot or
cold weather, alcohol, spicy foods, exercise, and certain skin care
products and medications.
Absent a cure for rosacea, treatment is aimed at alleviating the
disorder's symptoms. Topical or oral medications are generally prescribed
for mild to moderate papulopustular Rosacea, while oral medications are
prescribed for severe disease. Current oral antibiotic therapies may
alleviate symptoms of rosacea, but may present an issue with undesirable
side effects). While there are other topical products currently available
on the market, there is an opportunity to improve the existing irritation
profile for these treatments.
About Omiganan
Cutanea Life Sciences licensed the exclusive worldwide rights for
dermatological uses to a novel, cationic, antimicrobial peptide, whose
active component is omiganan pentahydrochloride from Migenix Inc., a
British Columbia Corporation located in Vancouver, BC, Canada (TSX: MGI;
OTC: MGIFF). Omiganan is in development as a topical treatment for
papulopustular rosacea and may prevent the inflammatory cascade that is
theorized to lead to the signs and symptoms of rosacea. Omiganan topical
gel has been evaluated in early stage clinical trials at concentrations of
0.5% and 3.0%, and early and late stage trials at 1.0%. At each of these
concentrations and in all trials conducted, omiganan was found to be safe,
well tolerated and non-irritating with no evidence of systemic absorption.
While cationic antimicrobial peptides, such as Omiganan, are well known for
their antimicrobial properties, recent research has shown that they also
may play a role in the inflammatory response. Omiganan, in in vitro assays,
demonstrated a rapid bactericidal activity against microorganisms that
colonize the skin and that may play a role in the pathogenesis of
inflammatory lesions.
About Cutanea
Cutanea Life Sciences is an emerging specialty pharmaceutical company
focused on improving human health and appearance through the development
and commercialization of treatments for diseased and aging skin conditions.
The Company strives to maximize value through flawless execution of
strategically designed programs. Its core strategy is to in-license novel,
patented, mid- stage treatment candidates for aggressive development as
potential market- leading dermatologic treatments for commercialization or
out-license. The Company focuses on leveraging each of its products to
address a variety of indications that serve the collective interest of
patients and medical professionals.
Cutanea Life Science's core competencies include a team of
professionals with more than 90 years of combined experience in developing
and commercializing healthcare products. In addition to the core team,
Cutanea is advised by a broad network of technical and commercial experts,
as well as practicing physicians and key medical opinion leaders.
Cutanea Life Sciences is a member of the family of bio/pharmaceutical
companies founded in conjunction with Paramount BioSciences, LLC.
CAUTION CONCERNING FORWARD LOOKING STATEMENTS:
This press release contains certain forward-looking information that is
intended to be covered by the safe harbor for "forward-looking statements"
provided by the Private Securities Litigation Reform Act of 1995. Forward-
looking statements are statements that are not historical facts. Words such
as "expect(s)," "feel(s)," "believe(s)," "will," "may," "anticipate(s)" and
similar expressions are intended to identify forward-looking statements.
These statements include, but are not limited to, financial projections and
estimates and their underlying assumptions; statements regarding plans,
objectives and expectations with respect to future operations, products and
services; and statements regarding future performance. Such statements are
subject to certain risks and uncertainties, many of which are difficult to
predict and generally beyond the control of Cutanea Life Sciences that
could cause actual results to differ materially from those expressed in, or
implied or projected by, the forward-looking information and statements.
These risks and uncertainties include: those generally associated with
developmental stage biopharmaceutical companies; the progress or likelihood
of success of our product research and development programs; the status of
our preclinical and clinical development of potential drugs; the likelihood
of success of our drug products in clinical trials and the regulatory
approval process; our drug products' efficacy, abuse and tamper resistance,
onset and duration of drug action, ability to provide protection from
overdose, ability to reduce the development of tolerance, ability to
improve symptomatology or otherwise improve patients' symptoms; the
incidence of adverse events; the ability to develop, manufacture, launch
and market our drug products; our projections for future revenues,
profitability and ability to achieve certain sales targets; our estimates
regarding our capital requirements and our needs for additional financing;
the likelihood of obtaining favorable scheduling and labeling of our drug
products; the likelihood of regulatory approval under Section 505(b)(2) and
other applicable Sections under the Federal Food, Drug, and Cosmetic Act;
our ability to develop safer and improved versions of widely- prescribed
drugs using our technology; and our ability to obtain favorable patent
claims. Readers are cautioned not to place undue reliance on these
forward-looking statements that speak only as of the date hereof. Cutanea
Life Sciences does not undertake any obligation to republish revised
forward- looking statements to reflect events or circumstances after the
date hereof or to reflect the occurrence of unanticipated events.
Cutanea Life Sciences
cutanealife
понедельник, 6 июня 2011 г.
FDA Approves New Drug Treatment For Long-Term Pain Relief After Shingles Attacks
The Food and Drug Administration (FDA) has approved the approval of Qutenza (capsaicin) 8% patch, a medicated skin patch that relieves the pain of post-herpetic neuralgia (PHN), a serious complication that can occur after a bout with shingles.
Shingles is an outbreak of rash or blisters on the skin that is caused by the same virus that causes chickenpox - the varicella-zoster virus. Anyone who once had chickenpox is at risk of shingles since the virus may become reactivated years after the initial infection. PHN is a condition affecting nerve fibers and the skin that can cause excruciating pain for weeks, months or even years. About 10 to 15 percent of patients who have shingles experience PHN and the complication is even more common in elderly patients.
Qutenza contains capsaicin, a compound found in chili peppers. Although there are over-the-counter products with lower concentrations of capsaicin that are marketed for the treatment of PHN, Qutenza is the first pure, concentrated, synthetic capsaicin-containing prescription drug to undergo FDA review . It was approved on Nov. 16.
"This new product can provide effective pain relief for patients who suffer from PHN," said Bob Rappaport, M.D., director of the Division of Anesthesia, Analgesia and Rheumatology Products in the FDA's Center for Drug Evaluation and Research.
The most frequently reported adverse drug reactions included pain, swelling, itching, redness, and bumps at the application site.
Qutenza must be applied to the skin by a health care professional since placement of the patch can be quite painful, requiring use of a local topical anesthetic, as well as additional pain relief such as ice or use of opioid pain relievers. The patient must also be monitored for at least one hour since there is a risk of a significant rise in blood pressure following patch placement.
The patch is manufactured by Lohmann Therapie-Systems AD of Andernach, Germany and distributed by NeurogesX Inc. of San Mateo, Calif.
Source
U.S Food and Drug Administration
Shingles is an outbreak of rash or blisters on the skin that is caused by the same virus that causes chickenpox - the varicella-zoster virus. Anyone who once had chickenpox is at risk of shingles since the virus may become reactivated years after the initial infection. PHN is a condition affecting nerve fibers and the skin that can cause excruciating pain for weeks, months or even years. About 10 to 15 percent of patients who have shingles experience PHN and the complication is even more common in elderly patients.
Qutenza contains capsaicin, a compound found in chili peppers. Although there are over-the-counter products with lower concentrations of capsaicin that are marketed for the treatment of PHN, Qutenza is the first pure, concentrated, synthetic capsaicin-containing prescription drug to undergo FDA review . It was approved on Nov. 16.
"This new product can provide effective pain relief for patients who suffer from PHN," said Bob Rappaport, M.D., director of the Division of Anesthesia, Analgesia and Rheumatology Products in the FDA's Center for Drug Evaluation and Research.
The most frequently reported adverse drug reactions included pain, swelling, itching, redness, and bumps at the application site.
Qutenza must be applied to the skin by a health care professional since placement of the patch can be quite painful, requiring use of a local topical anesthetic, as well as additional pain relief such as ice or use of opioid pain relievers. The patient must also be monitored for at least one hour since there is a risk of a significant rise in blood pressure following patch placement.
The patch is manufactured by Lohmann Therapie-Systems AD of Andernach, Germany and distributed by NeurogesX Inc. of San Mateo, Calif.
Source
U.S Food and Drug Administration
воскресенье, 5 июня 2011 г.
TEI Biosciences' PriMatrix(TM) Awarded Seal Of Approval By American Podiatric Medical Association
TEI Biosciences Inc. announced that its PriMatrix™ Dermal Repair Scaffold has been awarded the coveted American Podiatric Medical Association's (APMA) Seal of Approval. PriMatrix is a bioactive collagen matrix used in the management of diabetic and venous ulcers, second-degree burns, and surgical and trauma wounds.
APMA is the nation's leading professional society for foot and ankle specialists. The Seal of Approval Program was created to inform podiatric physicians and consumers about products whose quality, safety, and effectiveness promote good foot health. In order to qualify for the Seal of Approval, PriMatrix had to pass a thorough scientific evaluation by a panel of APMA members. The results were then evaluated by a committee of Doctors of Podiatric Medicine who decided to grant TEI the use of the Seal for PriMatrix.
"TEI is very excited about APMA's Seal of Approval award for PriMatrix," said Yiannis Monovoukas, Ph.D., TEI's Chairman, President and CEO. "PriMatrix is a novel biologic product proven safe and effective in treating many types of skin wounds in several thousand patients," said Dr. Monovoukas. "The addition of the APMA's Seal of Approval to PriMatrix is an affirmation of our commitment to developing innovative healthcare products that better meet the needs of physicians and their patients."
About PriMatrix™ Dermal Repair Scaffold
PriMatrix™ Dermal Repair Scaffold is an acellular collagen matrix derived from fetal bovine dermis, one of the purest forms of collagen available. Due to its bioactive collagen matrix technology, PriMatrix is an ideal material for the management of numerous types of wounds as it supports cell repopulation and revascularization processes essential to wound healing. PriMatrix is rich in Type III collagen, a natural component of fetal dermis that aids in tissue healing and regeneration.
PriMatrix is intended for the management of wounds that include: partial and full thickness wounds; pressure, diabetic, and venous ulcers; second-degree burns; surgical wounds; trauma wounds; tunneled/undermined wounds; and draining wounds.
About TEI Biosciences Inc.
A Boston-based, privately-held, leading biomedical company, TEI Biosciences Inc. has applied its expertise in regenerative medicine to develop and commercialize novel biologic products for a broad spectrum of soft tissue repair, regeneration, and reinforcement applications -- from plastic and reconstructive surgery to dura, tendon, and hernia repair, and wound management.
TEI sells its products directly and through partnerships with some of the world's major medical device companies. TEI's marketed products include:
-- SurgiMend® for plastic and reconstructive surgery, breast reconstruction, muscle flap reinforcement, hernia repair, and abdominal wall reconstruction;
-- PriMatrix™ for skin wound management;
-- Durepair® for cranial and spinal dura mater repair (marketed by Medtronic);
-- Xenform™ for pelvic floor reconstruction (marketed by Boston Scientific);
-- TissueMend® for tendon augmentation (marketed by Stryker).
APMA is the nation's leading professional society for foot and ankle specialists. The Seal of Approval Program was created to inform podiatric physicians and consumers about products whose quality, safety, and effectiveness promote good foot health. In order to qualify for the Seal of Approval, PriMatrix had to pass a thorough scientific evaluation by a panel of APMA members. The results were then evaluated by a committee of Doctors of Podiatric Medicine who decided to grant TEI the use of the Seal for PriMatrix.
"TEI is very excited about APMA's Seal of Approval award for PriMatrix," said Yiannis Monovoukas, Ph.D., TEI's Chairman, President and CEO. "PriMatrix is a novel biologic product proven safe and effective in treating many types of skin wounds in several thousand patients," said Dr. Monovoukas. "The addition of the APMA's Seal of Approval to PriMatrix is an affirmation of our commitment to developing innovative healthcare products that better meet the needs of physicians and their patients."
About PriMatrix™ Dermal Repair Scaffold
PriMatrix™ Dermal Repair Scaffold is an acellular collagen matrix derived from fetal bovine dermis, one of the purest forms of collagen available. Due to its bioactive collagen matrix technology, PriMatrix is an ideal material for the management of numerous types of wounds as it supports cell repopulation and revascularization processes essential to wound healing. PriMatrix is rich in Type III collagen, a natural component of fetal dermis that aids in tissue healing and regeneration.
PriMatrix is intended for the management of wounds that include: partial and full thickness wounds; pressure, diabetic, and venous ulcers; second-degree burns; surgical wounds; trauma wounds; tunneled/undermined wounds; and draining wounds.
About TEI Biosciences Inc.
A Boston-based, privately-held, leading biomedical company, TEI Biosciences Inc. has applied its expertise in regenerative medicine to develop and commercialize novel biologic products for a broad spectrum of soft tissue repair, regeneration, and reinforcement applications -- from plastic and reconstructive surgery to dura, tendon, and hernia repair, and wound management.
TEI sells its products directly and through partnerships with some of the world's major medical device companies. TEI's marketed products include:
-- SurgiMend® for plastic and reconstructive surgery, breast reconstruction, muscle flap reinforcement, hernia repair, and abdominal wall reconstruction;
-- PriMatrix™ for skin wound management;
-- Durepair® for cranial and spinal dura mater repair (marketed by Medtronic);
-- Xenform™ for pelvic floor reconstruction (marketed by Boston Scientific);
-- TissueMend® for tendon augmentation (marketed by Stryker).
суббота, 4 июня 2011 г.
GNI, Uniservices Joint Research On Melanoma And Breast Cancer
GNI Ltd, a Japan-based global group that develops new drugs, has partnered with Auckland Uniservices Limited in joint research analyzing the genome networks of melanoma and breast cancer.
The research will also delve into the effects of anticancer reagents on the genome network in patients. The genome network has been noted as a new approach in developing new drugs through discovery of druggable genome by analyzing tumor-inducing genomes that lead to the spread of diseases.
The project was commissioned by the Health Research Council of New Zealand (HRC) and Breast Cancer Research Trust (BCRT).
By Chris Lui, JCN Staff Writer
Copyright © 2006 JCN. All rights reserved. A division of Japan Corporate News Network KK.
JCN
The research will also delve into the effects of anticancer reagents on the genome network in patients. The genome network has been noted as a new approach in developing new drugs through discovery of druggable genome by analyzing tumor-inducing genomes that lead to the spread of diseases.
The project was commissioned by the Health Research Council of New Zealand (HRC) and Breast Cancer Research Trust (BCRT).
By Chris Lui, JCN Staff Writer
Copyright © 2006 JCN. All rights reserved. A division of Japan Corporate News Network KK.
JCN
четверг, 2 июня 2011 г.
Triple Drug Combination Is Promising Option To Treat Metastatic HER2+ Breast Cancer
Combining two chemotherapy drugs with trastuzumab (Herceptin) to treat women who have metastatic HER2+ breast cancer may offer physicians another choice in their treatment options.
At the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO), researchers from the Mayo Clinic campus in Florida report that using a combination of capecitabine, vinorelbine, and trastuzumab offers a treatment option that is at least as beneficial as other current options - and doesn't cause hair loss in patients.
"This is a very well tolerated regimen. The combination is a good example of an excellent therapeutic ratio: good activity and low toxicity," says the study's senior investigator, Edith Perez, M.D., director of Mayo Clinic's Breast Center in Jacksonville.
The clinical trial is the first in the United States to study this particular combination of therapies in patients with HER2+ metastatic breast cancer, researchers say. The chemotherapy regimen was previously tested in Europe and demonstrated good anti-tumor activity and low toxicity, so Mayo researchers combined it with Herceptin, says the study's lead author, Winston Tan, M.D., a medical oncologist at Mayo Clinic.
Sixty-seven percent of the 45 patients in this trial responded to treatment, with their tumors decreasing in size by at least 30 percent. Historic response to conventional drug regimens (one chemotherapy drug with Herceptin) that are currently used to treat metastatic HER2+ breast cancer is about 50 percent, Dr. Tan noted.
"The results are encouraging, and would support a larger, randomized Phase III study," he says. "This is a Phase II study of this triple combination, so we would need to study this treatment against the standard best two-drug treatment in a randomized Phase III study to know if this triplet is more effective."
"This regimen seems to be a very reasonable choice, and it offers the added advantage that women who use it do not lose their hair," he says. The drug combination used most commonly for patients with HER2+ breast cancer that has spread - paclitaxel or docetaxel with trastuzumab - always causes hair loss, Dr. Tan says.
All of the agents are approved for use by the U.S. Food and Drug Administration for cancer, although vinorelbine has not been approved for this particular treatment regimen in the U.S., the researchers say.
Capecitabine chemotherapy is not usually paired with trastuzumab because some studies had suggested it does not offer a synergistic, or additive, benefit. However, Dr. Tan says that newer research has shown the combination is in fact promising.
Among the patients studied, 28 (58 percent) had a partial response, a reduction in the size of the metastatic tumor of more than 30 percent by computed tomography. Four patients had a complete response with no more evidence of metastasized tumors on diagnostic scans, the researchers say.
Average survival was improved when compared historically to traditional treatment, Dr. Tan says. "Normally, survival for metastatic breast cancer is two years," he says. "In this study, average survival was 27 months." He cautioned that these results should be validated in a Phase III study.
"The toxicity was tolerable, no more than is seen with a two-drug regimen," he says. The majority of patients (61 percent) experienced a low white blood count, but only about ten percent of patients had fatigue or other common side effects.
Tan stressed that this regimen does not offer curative treatment, but it offers patients an improved quality of life compared to other commonly used regimens.
"It is very difficult to treat cancer that has spread, but we believe that combining treatments together is important to help shrink tumors that are rapidly growing," he says.
He adds that 80 percent of the patients who showed benefit had been treated with other chemotherapy drugs - mostly anthracyclines and paclitaxel - and at least half of the patients had used trastuzumab in the adjuvant or metastatic setting as well. "They still got a response to these combination of two chemotherapies plus the biological agent, and that is encouraging," he says.
At the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO), researchers from the Mayo Clinic campus in Florida report that using a combination of capecitabine, vinorelbine, and trastuzumab offers a treatment option that is at least as beneficial as other current options - and doesn't cause hair loss in patients.
"This is a very well tolerated regimen. The combination is a good example of an excellent therapeutic ratio: good activity and low toxicity," says the study's senior investigator, Edith Perez, M.D., director of Mayo Clinic's Breast Center in Jacksonville.
The clinical trial is the first in the United States to study this particular combination of therapies in patients with HER2+ metastatic breast cancer, researchers say. The chemotherapy regimen was previously tested in Europe and demonstrated good anti-tumor activity and low toxicity, so Mayo researchers combined it with Herceptin, says the study's lead author, Winston Tan, M.D., a medical oncologist at Mayo Clinic.
Sixty-seven percent of the 45 patients in this trial responded to treatment, with their tumors decreasing in size by at least 30 percent. Historic response to conventional drug regimens (one chemotherapy drug with Herceptin) that are currently used to treat metastatic HER2+ breast cancer is about 50 percent, Dr. Tan noted.
"The results are encouraging, and would support a larger, randomized Phase III study," he says. "This is a Phase II study of this triple combination, so we would need to study this treatment against the standard best two-drug treatment in a randomized Phase III study to know if this triplet is more effective."
"This regimen seems to be a very reasonable choice, and it offers the added advantage that women who use it do not lose their hair," he says. The drug combination used most commonly for patients with HER2+ breast cancer that has spread - paclitaxel or docetaxel with trastuzumab - always causes hair loss, Dr. Tan says.
All of the agents are approved for use by the U.S. Food and Drug Administration for cancer, although vinorelbine has not been approved for this particular treatment regimen in the U.S., the researchers say.
Capecitabine chemotherapy is not usually paired with trastuzumab because some studies had suggested it does not offer a synergistic, or additive, benefit. However, Dr. Tan says that newer research has shown the combination is in fact promising.
Among the patients studied, 28 (58 percent) had a partial response, a reduction in the size of the metastatic tumor of more than 30 percent by computed tomography. Four patients had a complete response with no more evidence of metastasized tumors on diagnostic scans, the researchers say.
Average survival was improved when compared historically to traditional treatment, Dr. Tan says. "Normally, survival for metastatic breast cancer is two years," he says. "In this study, average survival was 27 months." He cautioned that these results should be validated in a Phase III study.
"The toxicity was tolerable, no more than is seen with a two-drug regimen," he says. The majority of patients (61 percent) experienced a low white blood count, but only about ten percent of patients had fatigue or other common side effects.
Tan stressed that this regimen does not offer curative treatment, but it offers patients an improved quality of life compared to other commonly used regimens.
"It is very difficult to treat cancer that has spread, but we believe that combining treatments together is important to help shrink tumors that are rapidly growing," he says.
He adds that 80 percent of the patients who showed benefit had been treated with other chemotherapy drugs - mostly anthracyclines and paclitaxel - and at least half of the patients had used trastuzumab in the adjuvant or metastatic setting as well. "They still got a response to these combination of two chemotherapies plus the biological agent, and that is encouraging," he says.
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