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Cicatricial Alopecia
A great victory for our patients suffering from cicatricial alopecia—Dr. Pratima Karnik, assistant professor of dermatology at Cleveland’s Case Western Reserve University, received a $1.77 National Institutes of Health grant to fund a 5 year study on hair follicle, stem cell specific, PPAR-gamma deficiency in scarring alopecia.
Her research, published in the Journal of Investigative Dermatology, linked a defect in lipid processing and peroxisome biogenesis to cicatricial alopecia. As a result, it paved the way for a breakthrough finding in understanding the pathophysiology of the permanent hair loss disorder (J Invest Dermatol. 2009 May;129(5):1066-70).
Dr. Karnik and her colleagues found that unprocessed lipids are responsible for developing scarring hair loss. Their research suggests that processed lipids are necessary for hair growth and unprocessed lipids are toxic to hair. The bench-side research has led to clinical findings that treating patients with drugs that enhance lipid processing may relieve the clinical symptoms of the disorder.
Central centrifugal cicatricial alopecia, a scarring hair loss prevalent in African Americans, has no well-defined cause and has been difficult to and frustrating for patients.
Dr. Karnik’s research, and the work of the Cicatricial Alopecia Research Foundation (www.carfintl.org), is helping patients and physicians understand the biology, natural history, and treatment options for patients.
I personally attended a session with NIH Director Dr. Francis S. Collins, on behalf of CARF, where underrepresented and underfunded organizations had a chance to voice their opinions to the NIH and gain the well deserved attention they need.
Dr. Collins suggested that a new structure of communication was being established at the NIH, noting that any organization can send a brief summary of issues it would like to bring to the attention of the NIH. The e-mail address is nih-listens@nih.gov. He ensured us he would look at every e-mail and respond to each one.
Often, rare diseases are difficult to study given the lack of attention and funding. The work of Dr. Karnik and her collaborative team, and organizations like CARF, give hope to the thousands of people suffering from cicatricial alopecia.
A great victory for our patients suffering from cicatricial alopecia—Dr. Pratima Karnik, assistant professor of dermatology at Cleveland’s Case Western Reserve University, received a $1.77 National Institutes of Health grant to fund a 5 year study on hair follicle, stem cell specific, PPAR-gamma deficiency in scarring alopecia.
Her research, published in the Journal of Investigative Dermatology, linked a defect in lipid processing and peroxisome biogenesis to cicatricial alopecia. As a result, it paved the way for a breakthrough finding in understanding the pathophysiology of the permanent hair loss disorder (J Invest Dermatol. 2009 May;129(5):1066-70).
Dr. Karnik and her colleagues found that unprocessed lipids are responsible for developing scarring hair loss. Their research suggests that processed lipids are necessary for hair growth and unprocessed lipids are toxic to hair. The bench-side research has led to clinical findings that treating patients with drugs that enhance lipid processing may relieve the clinical symptoms of the disorder.
Central centrifugal cicatricial alopecia, a scarring hair loss prevalent in African Americans, has no well-defined cause and has been difficult to and frustrating for patients.
Dr. Karnik’s research, and the work of the Cicatricial Alopecia Research Foundation (www.carfintl.org), is helping patients and physicians understand the biology, natural history, and treatment options for patients.
I personally attended a session with NIH Director Dr. Francis S. Collins, on behalf of CARF, where underrepresented and underfunded organizations had a chance to voice their opinions to the NIH and gain the well deserved attention they need.
Dr. Collins suggested that a new structure of communication was being established at the NIH, noting that any organization can send a brief summary of issues it would like to bring to the attention of the NIH. The e-mail address is nih-listens@nih.gov. He ensured us he would look at every e-mail and respond to each one.
Often, rare diseases are difficult to study given the lack of attention and funding. The work of Dr. Karnik and her collaborative team, and organizations like CARF, give hope to the thousands of people suffering from cicatricial alopecia.
A great victory for our patients suffering from cicatricial alopecia—Dr. Pratima Karnik, assistant professor of dermatology at Cleveland’s Case Western Reserve University, received a $1.77 National Institutes of Health grant to fund a 5 year study on hair follicle, stem cell specific, PPAR-gamma deficiency in scarring alopecia.
Her research, published in the Journal of Investigative Dermatology, linked a defect in lipid processing and peroxisome biogenesis to cicatricial alopecia. As a result, it paved the way for a breakthrough finding in understanding the pathophysiology of the permanent hair loss disorder (J Invest Dermatol. 2009 May;129(5):1066-70).
Dr. Karnik and her colleagues found that unprocessed lipids are responsible for developing scarring hair loss. Their research suggests that processed lipids are necessary for hair growth and unprocessed lipids are toxic to hair. The bench-side research has led to clinical findings that treating patients with drugs that enhance lipid processing may relieve the clinical symptoms of the disorder.
Central centrifugal cicatricial alopecia, a scarring hair loss prevalent in African Americans, has no well-defined cause and has been difficult to and frustrating for patients.
Dr. Karnik’s research, and the work of the Cicatricial Alopecia Research Foundation (www.carfintl.org), is helping patients and physicians understand the biology, natural history, and treatment options for patients.
I personally attended a session with NIH Director Dr. Francis S. Collins, on behalf of CARF, where underrepresented and underfunded organizations had a chance to voice their opinions to the NIH and gain the well deserved attention they need.
Dr. Collins suggested that a new structure of communication was being established at the NIH, noting that any organization can send a brief summary of issues it would like to bring to the attention of the NIH. The e-mail address is nih-listens@nih.gov. He ensured us he would look at every e-mail and respond to each one.
Often, rare diseases are difficult to study given the lack of attention and funding. The work of Dr. Karnik and her collaborative team, and organizations like CARF, give hope to the thousands of people suffering from cicatricial alopecia.
FDA Sends Strong Lipodissolve Warning to Med Spas
The Food and Drug Administration announced April 7 that it sent warning letters to six medical spas and a Brazilian company asking them to cease and desist from making false and misleading claims about injectable lipodissolve products.
The companies cited by the FDA have made claims that their injectables are superior to other fat-dissolving or -removing procedures, and the injections can treat conditions such as gynecomastia and surgical deformities, said Kathleen Anderson, deputy director of the Division of New Drugs and Labeling Compliance at the FDA’s Center for Drug Evaluation and Research, in a briefing with reporters. The claims are illegal without clinical evidence or explicit FDA approval for the injectables, which generally contain phosphatidylcholine (PPC) and/or deoxycholate, and a variety of vitamins, minerals, and herbal extracts.
The letters were sent by overnight mail on April 5 to six American spas: Monarch Medspa, King of Prussia, Penn.; Spa 35, Boise, Idaho; Medical Cosmetic Enhancements, Chevy Chase, Md.; Innovative Directions in Health, Edina, Minn.; Pure Med Spa, Boca Raton, Fla.; and All About You Med Spa, Madison, Ind.
The Brazilian company cited by the FDA sells lipodissolve products through its two Web sites www.zipmed.net and www.mesoone.com. The agency has issued an import alert for the Web sites, which should prevent the importation and distribution of the products.
Ms. Anderson said the companies were singled out because they had made what were considered to be the most egregious claims among the sites the FDA has monitored.
The agency is hoping to warn consumers that if they purchase these services, they are receiving therapies that are not approved by the FDA, she said. In addition, the drug components—PPC and deoxycholate—are not specifically approved as injectables or for fat dissolution. They are approved for inhalation as a lung surfactant in acute respiratory distress syndrome, said Ms. Anderson.
A complete list of concerns about lipodissolve, also known as mesotherapy or injectable lipolysis, can be found on an updated page for consumers on the FDA Web site. Among the safety concerns are permanent scarring, skin deformation, and painful knots under the skin. The agency has received five reports of such adverse events, Ms. Anderson said.
The FDA also said that clinicians who are using lipodissolve products should submit an application for approval so the agency can evaluate safety and efficacy. The Aesthetic Surgery Education and Research Foundation is conducting a small, placebo-controlled study using sham injections, compared with injections of PPC and sodium deoxycholate. The FDA has approved the study.
But most professional societies, including the Physicians Coalition for Injectable Safety, the American Society for Aesthetic Plastic Surgery (ASAPS), and the American Society for Dermatologic Surgery, have warned against fat-dissolving injections until there is further proof of efficacy and safety.
The FDA, for its part, said it would be monitoring further use of lipodissolve, whether by unlicensed practitioners or physicians. “If there are clinics and medical practices that are going to be making false and misleading claims, then we will go after them as well,” said Sudha Shukla, Pharm. D., of the FDA’s Division of New Drugs and Labeling Compliance, during the briefing.
It is not clear how many lipodissolve procedures are done each year. The ASAPS reported that 18,000 were done in 2008, but that an insufficient number of clinicians responded to its annual survey in 2009 to give a reliable number.
The companies cited by the FDA have 15 days to respond to the agency’s warning. If sufficient steps are not taken, then the agency has the power to issue an injunction or seize products, said Ms. Anderson.
The Food and Drug Administration announced April 7 that it sent warning letters to six medical spas and a Brazilian company asking them to cease and desist from making false and misleading claims about injectable lipodissolve products.
The companies cited by the FDA have made claims that their injectables are superior to other fat-dissolving or -removing procedures, and the injections can treat conditions such as gynecomastia and surgical deformities, said Kathleen Anderson, deputy director of the Division of New Drugs and Labeling Compliance at the FDA’s Center for Drug Evaluation and Research, in a briefing with reporters. The claims are illegal without clinical evidence or explicit FDA approval for the injectables, which generally contain phosphatidylcholine (PPC) and/or deoxycholate, and a variety of vitamins, minerals, and herbal extracts.
The letters were sent by overnight mail on April 5 to six American spas: Monarch Medspa, King of Prussia, Penn.; Spa 35, Boise, Idaho; Medical Cosmetic Enhancements, Chevy Chase, Md.; Innovative Directions in Health, Edina, Minn.; Pure Med Spa, Boca Raton, Fla.; and All About You Med Spa, Madison, Ind.
The Brazilian company cited by the FDA sells lipodissolve products through its two Web sites www.zipmed.net and www.mesoone.com. The agency has issued an import alert for the Web sites, which should prevent the importation and distribution of the products.
Ms. Anderson said the companies were singled out because they had made what were considered to be the most egregious claims among the sites the FDA has monitored.
The agency is hoping to warn consumers that if they purchase these services, they are receiving therapies that are not approved by the FDA, she said. In addition, the drug components—PPC and deoxycholate—are not specifically approved as injectables or for fat dissolution. They are approved for inhalation as a lung surfactant in acute respiratory distress syndrome, said Ms. Anderson.
A complete list of concerns about lipodissolve, also known as mesotherapy or injectable lipolysis, can be found on an updated page for consumers on the FDA Web site. Among the safety concerns are permanent scarring, skin deformation, and painful knots under the skin. The agency has received five reports of such adverse events, Ms. Anderson said.
The FDA also said that clinicians who are using lipodissolve products should submit an application for approval so the agency can evaluate safety and efficacy. The Aesthetic Surgery Education and Research Foundation is conducting a small, placebo-controlled study using sham injections, compared with injections of PPC and sodium deoxycholate. The FDA has approved the study.
But most professional societies, including the Physicians Coalition for Injectable Safety, the American Society for Aesthetic Plastic Surgery (ASAPS), and the American Society for Dermatologic Surgery, have warned against fat-dissolving injections until there is further proof of efficacy and safety.
The FDA, for its part, said it would be monitoring further use of lipodissolve, whether by unlicensed practitioners or physicians. “If there are clinics and medical practices that are going to be making false and misleading claims, then we will go after them as well,” said Sudha Shukla, Pharm. D., of the FDA’s Division of New Drugs and Labeling Compliance, during the briefing.
It is not clear how many lipodissolve procedures are done each year. The ASAPS reported that 18,000 were done in 2008, but that an insufficient number of clinicians responded to its annual survey in 2009 to give a reliable number.
The companies cited by the FDA have 15 days to respond to the agency’s warning. If sufficient steps are not taken, then the agency has the power to issue an injunction or seize products, said Ms. Anderson.
The Food and Drug Administration announced April 7 that it sent warning letters to six medical spas and a Brazilian company asking them to cease and desist from making false and misleading claims about injectable lipodissolve products.
The companies cited by the FDA have made claims that their injectables are superior to other fat-dissolving or -removing procedures, and the injections can treat conditions such as gynecomastia and surgical deformities, said Kathleen Anderson, deputy director of the Division of New Drugs and Labeling Compliance at the FDA’s Center for Drug Evaluation and Research, in a briefing with reporters. The claims are illegal without clinical evidence or explicit FDA approval for the injectables, which generally contain phosphatidylcholine (PPC) and/or deoxycholate, and a variety of vitamins, minerals, and herbal extracts.
The letters were sent by overnight mail on April 5 to six American spas: Monarch Medspa, King of Prussia, Penn.; Spa 35, Boise, Idaho; Medical Cosmetic Enhancements, Chevy Chase, Md.; Innovative Directions in Health, Edina, Minn.; Pure Med Spa, Boca Raton, Fla.; and All About You Med Spa, Madison, Ind.
The Brazilian company cited by the FDA sells lipodissolve products through its two Web sites www.zipmed.net and www.mesoone.com. The agency has issued an import alert for the Web sites, which should prevent the importation and distribution of the products.
Ms. Anderson said the companies were singled out because they had made what were considered to be the most egregious claims among the sites the FDA has monitored.
The agency is hoping to warn consumers that if they purchase these services, they are receiving therapies that are not approved by the FDA, she said. In addition, the drug components—PPC and deoxycholate—are not specifically approved as injectables or for fat dissolution. They are approved for inhalation as a lung surfactant in acute respiratory distress syndrome, said Ms. Anderson.
A complete list of concerns about lipodissolve, also known as mesotherapy or injectable lipolysis, can be found on an updated page for consumers on the FDA Web site. Among the safety concerns are permanent scarring, skin deformation, and painful knots under the skin. The agency has received five reports of such adverse events, Ms. Anderson said.
The FDA also said that clinicians who are using lipodissolve products should submit an application for approval so the agency can evaluate safety and efficacy. The Aesthetic Surgery Education and Research Foundation is conducting a small, placebo-controlled study using sham injections, compared with injections of PPC and sodium deoxycholate. The FDA has approved the study.
But most professional societies, including the Physicians Coalition for Injectable Safety, the American Society for Aesthetic Plastic Surgery (ASAPS), and the American Society for Dermatologic Surgery, have warned against fat-dissolving injections until there is further proof of efficacy and safety.
The FDA, for its part, said it would be monitoring further use of lipodissolve, whether by unlicensed practitioners or physicians. “If there are clinics and medical practices that are going to be making false and misleading claims, then we will go after them as well,” said Sudha Shukla, Pharm. D., of the FDA’s Division of New Drugs and Labeling Compliance, during the briefing.
It is not clear how many lipodissolve procedures are done each year. The ASAPS reported that 18,000 were done in 2008, but that an insufficient number of clinicians responded to its annual survey in 2009 to give a reliable number.
The companies cited by the FDA have 15 days to respond to the agency’s warning. If sufficient steps are not taken, then the agency has the power to issue an injunction or seize products, said Ms. Anderson.
The Topical Nutritional Pyramid: A Method for Educating Patients on Skin-Rejuvenating Cosmeceuticals
Novel Synthetic Oligopeptide Formulation Offers Nonirritating Cosmetic Alternative for the Treatment of Melasma
Chemical Depressor Myectomy With Botulinum Toxin Type A for the Treatment of Transient Paralysis of the Marginal Mandibular Branch of the Facial Nerve Following Laser-Assisted Liposuction of the Neck
The Art of Eyelash Beautification
FDA Approves Polidocanol for Treating Small Varicose Veins
Polidocanol injection for treating varicose veins has been approved by the Food and Drug Administration, according to the agency.
Distributed by BioFarm Medical Inc. as Asclera, polidocanol is approved to treat small spider and reticular veins, specifically those ranging in size from less than 1 mm to up to 3 mm. The injectable agent improves the appearance of varicose veins by damaging the cell lining of the blood vessels, thus causing vessels to close and be replaced by less-visible types of tissue.
"Varicose veins are a common condition. Asclera is indicated for the treatment of small types of varicose veins when the aim of treatment is to improve appearance," said Dr. Norman Stockbridge, director of the division of cardiovascular and renal products at the FDA's Center for Drug Evaluation and Research, Silver Spring, Md.
It is estimated that as many as 55% of American women and 45% of American men have some form of vein problem, according to the U.S. Department of Health and Human Services. Varicose veins affect half of people age 50 years and older.
Asclera is manufactured by the German company Chemische Fabrik Kreussler & Co.
Common adverse reactions to polidocanol include leakage and collection of blood from damaged blood vessels at the injection site (hematoma), bruising, irritation, discoloration, and pain at the injection site, the FDA said.
Most commonly occurring in the legs, varicose veins are caused by a number of factors, including genetics, age, female gender, pregnancy, and obesity; prolonged periods of standing may increase the risk for varicose veins, according to the agency.
Polidocanol has been used to treat varicose veins in Europe for more than 40 years.
Polidocanol injection for treating varicose veins has been approved by the Food and Drug Administration, according to the agency.
Distributed by BioFarm Medical Inc. as Asclera, polidocanol is approved to treat small spider and reticular veins, specifically those ranging in size from less than 1 mm to up to 3 mm. The injectable agent improves the appearance of varicose veins by damaging the cell lining of the blood vessels, thus causing vessels to close and be replaced by less-visible types of tissue.
"Varicose veins are a common condition. Asclera is indicated for the treatment of small types of varicose veins when the aim of treatment is to improve appearance," said Dr. Norman Stockbridge, director of the division of cardiovascular and renal products at the FDA's Center for Drug Evaluation and Research, Silver Spring, Md.
It is estimated that as many as 55% of American women and 45% of American men have some form of vein problem, according to the U.S. Department of Health and Human Services. Varicose veins affect half of people age 50 years and older.
Asclera is manufactured by the German company Chemische Fabrik Kreussler & Co.
Common adverse reactions to polidocanol include leakage and collection of blood from damaged blood vessels at the injection site (hematoma), bruising, irritation, discoloration, and pain at the injection site, the FDA said.
Most commonly occurring in the legs, varicose veins are caused by a number of factors, including genetics, age, female gender, pregnancy, and obesity; prolonged periods of standing may increase the risk for varicose veins, according to the agency.
Polidocanol has been used to treat varicose veins in Europe for more than 40 years.
Polidocanol injection for treating varicose veins has been approved by the Food and Drug Administration, according to the agency.
Distributed by BioFarm Medical Inc. as Asclera, polidocanol is approved to treat small spider and reticular veins, specifically those ranging in size from less than 1 mm to up to 3 mm. The injectable agent improves the appearance of varicose veins by damaging the cell lining of the blood vessels, thus causing vessels to close and be replaced by less-visible types of tissue.
"Varicose veins are a common condition. Asclera is indicated for the treatment of small types of varicose veins when the aim of treatment is to improve appearance," said Dr. Norman Stockbridge, director of the division of cardiovascular and renal products at the FDA's Center for Drug Evaluation and Research, Silver Spring, Md.
It is estimated that as many as 55% of American women and 45% of American men have some form of vein problem, according to the U.S. Department of Health and Human Services. Varicose veins affect half of people age 50 years and older.
Asclera is manufactured by the German company Chemische Fabrik Kreussler & Co.
Common adverse reactions to polidocanol include leakage and collection of blood from damaged blood vessels at the injection site (hematoma), bruising, irritation, discoloration, and pain at the injection site, the FDA said.
Most commonly occurring in the legs, varicose veins are caused by a number of factors, including genetics, age, female gender, pregnancy, and obesity; prolonged periods of standing may increase the risk for varicose veins, according to the agency.
Polidocanol has been used to treat varicose veins in Europe for more than 40 years.
Medicare to Cover Facial Fillers for Lipoatrophy in HIV Patients
Medicare will now cover the use of facial fillers for beneficiaries whose facial lipoatrophy resulting from treatment for HIV infection has contributed significantly to depression, the Centers for Medicare and Medicaid Services announced yesterday.
The decision, which applies only to fillers specifically approved for use in facial lipoatrophy, became effective immediately, according to the agency's national coverage determination memo
Facial lipoatrophy, a side effect of highly active antiretroviral therapy (HAART), involves localized loss of fat from the face and thinning of the overlying skin, which causes an excessively thin and hollow appearance in the cheeks.
As the condition progresses, underlying facial muscles may appear more prominent, making the patient appear ill or prematurely aged. Fat lost from the face may redistribute to other parts of the body, such as the abdomen, neck, and breasts.
"Patients have reported feeling stigmatized by these changes, particularly if their HIV status has not been disclosed previously, and believe their relationships with others are adversely affected," the decision said.
About 13%-38% of HAART-treated patients suffer from facial lipoatrophy, leading some to discontinue their medications, according to the decision.
Two fillers, Radiesse (calcium hydroxylapatite) and Sculptra (poly-L-lactic acid), are approved by the Food and Drug Administration to correct facial fat loss in people with HIV. According to the CMS decision, the agency will only cover the procedure in patients whose gaunt appearance "is a significant contributor to their depression."
Studies have shown that use of facial fillers can improve patient self-image, relieve symptoms of depression, and may lead to improved compliance with antiretroviral treatment, CMS said in its decision.
Although HIV is rare in the over-65 Medicare population, HIV-infected individuals under age 65 years may qualify for Medicare based on disability.
Implants or injectable soft-tissue materials such as bovine or human collagen, silicone, or autologous fat also have been used to treat HIV-related facial LDS, according to CMS, but the agency did not address those in its decision.
Medicare will now cover the use of facial fillers for beneficiaries whose facial lipoatrophy resulting from treatment for HIV infection has contributed significantly to depression, the Centers for Medicare and Medicaid Services announced yesterday.
The decision, which applies only to fillers specifically approved for use in facial lipoatrophy, became effective immediately, according to the agency's national coverage determination memo
Facial lipoatrophy, a side effect of highly active antiretroviral therapy (HAART), involves localized loss of fat from the face and thinning of the overlying skin, which causes an excessively thin and hollow appearance in the cheeks.
As the condition progresses, underlying facial muscles may appear more prominent, making the patient appear ill or prematurely aged. Fat lost from the face may redistribute to other parts of the body, such as the abdomen, neck, and breasts.
"Patients have reported feeling stigmatized by these changes, particularly if their HIV status has not been disclosed previously, and believe their relationships with others are adversely affected," the decision said.
About 13%-38% of HAART-treated patients suffer from facial lipoatrophy, leading some to discontinue their medications, according to the decision.
Two fillers, Radiesse (calcium hydroxylapatite) and Sculptra (poly-L-lactic acid), are approved by the Food and Drug Administration to correct facial fat loss in people with HIV. According to the CMS decision, the agency will only cover the procedure in patients whose gaunt appearance "is a significant contributor to their depression."
Studies have shown that use of facial fillers can improve patient self-image, relieve symptoms of depression, and may lead to improved compliance with antiretroviral treatment, CMS said in its decision.
Although HIV is rare in the over-65 Medicare population, HIV-infected individuals under age 65 years may qualify for Medicare based on disability.
Implants or injectable soft-tissue materials such as bovine or human collagen, silicone, or autologous fat also have been used to treat HIV-related facial LDS, according to CMS, but the agency did not address those in its decision.
Medicare will now cover the use of facial fillers for beneficiaries whose facial lipoatrophy resulting from treatment for HIV infection has contributed significantly to depression, the Centers for Medicare and Medicaid Services announced yesterday.
The decision, which applies only to fillers specifically approved for use in facial lipoatrophy, became effective immediately, according to the agency's national coverage determination memo
Facial lipoatrophy, a side effect of highly active antiretroviral therapy (HAART), involves localized loss of fat from the face and thinning of the overlying skin, which causes an excessively thin and hollow appearance in the cheeks.
As the condition progresses, underlying facial muscles may appear more prominent, making the patient appear ill or prematurely aged. Fat lost from the face may redistribute to other parts of the body, such as the abdomen, neck, and breasts.
"Patients have reported feeling stigmatized by these changes, particularly if their HIV status has not been disclosed previously, and believe their relationships with others are adversely affected," the decision said.
About 13%-38% of HAART-treated patients suffer from facial lipoatrophy, leading some to discontinue their medications, according to the decision.
Two fillers, Radiesse (calcium hydroxylapatite) and Sculptra (poly-L-lactic acid), are approved by the Food and Drug Administration to correct facial fat loss in people with HIV. According to the CMS decision, the agency will only cover the procedure in patients whose gaunt appearance "is a significant contributor to their depression."
Studies have shown that use of facial fillers can improve patient self-image, relieve symptoms of depression, and may lead to improved compliance with antiretroviral treatment, CMS said in its decision.
Although HIV is rare in the over-65 Medicare population, HIV-infected individuals under age 65 years may qualify for Medicare based on disability.
Implants or injectable soft-tissue materials such as bovine or human collagen, silicone, or autologous fat also have been used to treat HIV-related facial LDS, according to CMS, but the agency did not address those in its decision.
Fractional Laser Resurfacing Suitable for Eyelids
ORLANDO - The fractional eCO2 laser appears to be an effective and safe tool for eyelid resurfacing, with quick re-epithelialization and resolution of erythema, according to a chart review of 28 patients.
Eyelid resurfacing with the Lutronic eCO2 laser holds several advantages over traditional CO2 laser resurfacing, said Dr. Woodward of Duke University Medical Center, Durham, N.C.
"Fractional eCO2 allows laser energy to heat tissue deep in the reticular dermis via microablative columns without removing all of the surface epithelium as traditional CO2 lasers did," she said in an interview. "The healing time is significantly reduced with fractional eCO2 in comparison to traditional resurfacing, which is an advantage for patients who want to return to work."
All of the 28 patients underwent eyelid resurfacing with the eCO2 laser. The study included patients with Fitzpatrick skin types I-IV, with the majority being II and III. Patients were randomly assigned to the 120-mcm spot size (17) or the 300-mcm spot size (11).
Twenty of the patients underwent a concurrent bilateral lower-lid transconjunctival blepharoplasty. They were instructed to use vinegar and Aquaphor for the first two postop days, followed by vinegar and a sunscreen with zinc until epithelialization.
Two physicians who were blinded to the clinic visits evaluated patient response by rating more than 260 photos, which were presented in random order from preoperative to 6 months postoperative. They rated erythema, rhytids, telangiectasias, and dyschromia. The study also included patient reports of overall satisfaction and dry eye.
Erythema was similar in both groups, peaking at 1 week (level of 2 on 4-point scale) and then decreasing sharply to 0.5 by 1 month and 0 by 6 months.
Patients in the 120-mcm group experienced epithelization in an average of 5.6 days; the 300-mcm group took 6.4 days.
Rhytids, rated on a 3-point scale, decreased from an average of 2.5 to 1 by 1 week, with no significant between-group difference. By 6 months, rhytids were an average of 1.7, with no difference between the groups.
Telangiectasias were low at baseline (0.25 on a 5-point scale) and remained unchanged by 6 months, with no between-group difference. There also was no difference in the occurrence of dry eye. Dyschromias improved from 1 to 0.5. Patient satisfaction was high in both groups, rising from 0 to 2.5 on a scale of 0-4 at 1 month and 3.5 at 6 months. Patient satisfaction for the eight patients who did not have blepharoplasty was very similar.
There was no ectropion, infection, herpetic outbreaks, or hypopigmentation. Two patients developed postinflammatory hyperpigmentation, which resolved with hydroquinone 4%.
"This is an exciting new treatment with high patient satisfaction that can be done in a single treatment under local anesthesia. Traditional CO2 resurfacing may tighten the skin and reduce more rhytids than fractional resurfacing, but with the eCO2 laser, a physician can use the 1-mm spot size to do a traditional resurfacing if indicated," Dr. Woodward said.
The laser used in the study is on loan from the manufacturer, Lutronic Inc. Neither Dr. Woodward nor any of her coinvestigators accept remuneration from the company.
ORLANDO - The fractional eCO2 laser appears to be an effective and safe tool for eyelid resurfacing, with quick re-epithelialization and resolution of erythema, according to a chart review of 28 patients.
Eyelid resurfacing with the Lutronic eCO2 laser holds several advantages over traditional CO2 laser resurfacing, said Dr. Woodward of Duke University Medical Center, Durham, N.C.
"Fractional eCO2 allows laser energy to heat tissue deep in the reticular dermis via microablative columns without removing all of the surface epithelium as traditional CO2 lasers did," she said in an interview. "The healing time is significantly reduced with fractional eCO2 in comparison to traditional resurfacing, which is an advantage for patients who want to return to work."
All of the 28 patients underwent eyelid resurfacing with the eCO2 laser. The study included patients with Fitzpatrick skin types I-IV, with the majority being II and III. Patients were randomly assigned to the 120-mcm spot size (17) or the 300-mcm spot size (11).
Twenty of the patients underwent a concurrent bilateral lower-lid transconjunctival blepharoplasty. They were instructed to use vinegar and Aquaphor for the first two postop days, followed by vinegar and a sunscreen with zinc until epithelialization.
Two physicians who were blinded to the clinic visits evaluated patient response by rating more than 260 photos, which were presented in random order from preoperative to 6 months postoperative. They rated erythema, rhytids, telangiectasias, and dyschromia. The study also included patient reports of overall satisfaction and dry eye.
Erythema was similar in both groups, peaking at 1 week (level of 2 on 4-point scale) and then decreasing sharply to 0.5 by 1 month and 0 by 6 months.
Patients in the 120-mcm group experienced epithelization in an average of 5.6 days; the 300-mcm group took 6.4 days.
Rhytids, rated on a 3-point scale, decreased from an average of 2.5 to 1 by 1 week, with no significant between-group difference. By 6 months, rhytids were an average of 1.7, with no difference between the groups.
Telangiectasias were low at baseline (0.25 on a 5-point scale) and remained unchanged by 6 months, with no between-group difference. There also was no difference in the occurrence of dry eye. Dyschromias improved from 1 to 0.5. Patient satisfaction was high in both groups, rising from 0 to 2.5 on a scale of 0-4 at 1 month and 3.5 at 6 months. Patient satisfaction for the eight patients who did not have blepharoplasty was very similar.
There was no ectropion, infection, herpetic outbreaks, or hypopigmentation. Two patients developed postinflammatory hyperpigmentation, which resolved with hydroquinone 4%.
"This is an exciting new treatment with high patient satisfaction that can be done in a single treatment under local anesthesia. Traditional CO2 resurfacing may tighten the skin and reduce more rhytids than fractional resurfacing, but with the eCO2 laser, a physician can use the 1-mm spot size to do a traditional resurfacing if indicated," Dr. Woodward said.
The laser used in the study is on loan from the manufacturer, Lutronic Inc. Neither Dr. Woodward nor any of her coinvestigators accept remuneration from the company.
ORLANDO - The fractional eCO2 laser appears to be an effective and safe tool for eyelid resurfacing, with quick re-epithelialization and resolution of erythema, according to a chart review of 28 patients.
Eyelid resurfacing with the Lutronic eCO2 laser holds several advantages over traditional CO2 laser resurfacing, said Dr. Woodward of Duke University Medical Center, Durham, N.C.
"Fractional eCO2 allows laser energy to heat tissue deep in the reticular dermis via microablative columns without removing all of the surface epithelium as traditional CO2 lasers did," she said in an interview. "The healing time is significantly reduced with fractional eCO2 in comparison to traditional resurfacing, which is an advantage for patients who want to return to work."
All of the 28 patients underwent eyelid resurfacing with the eCO2 laser. The study included patients with Fitzpatrick skin types I-IV, with the majority being II and III. Patients were randomly assigned to the 120-mcm spot size (17) or the 300-mcm spot size (11).
Twenty of the patients underwent a concurrent bilateral lower-lid transconjunctival blepharoplasty. They were instructed to use vinegar and Aquaphor for the first two postop days, followed by vinegar and a sunscreen with zinc until epithelialization.
Two physicians who were blinded to the clinic visits evaluated patient response by rating more than 260 photos, which were presented in random order from preoperative to 6 months postoperative. They rated erythema, rhytids, telangiectasias, and dyschromia. The study also included patient reports of overall satisfaction and dry eye.
Erythema was similar in both groups, peaking at 1 week (level of 2 on 4-point scale) and then decreasing sharply to 0.5 by 1 month and 0 by 6 months.
Patients in the 120-mcm group experienced epithelization in an average of 5.6 days; the 300-mcm group took 6.4 days.
Rhytids, rated on a 3-point scale, decreased from an average of 2.5 to 1 by 1 week, with no significant between-group difference. By 6 months, rhytids were an average of 1.7, with no difference between the groups.
Telangiectasias were low at baseline (0.25 on a 5-point scale) and remained unchanged by 6 months, with no between-group difference. There also was no difference in the occurrence of dry eye. Dyschromias improved from 1 to 0.5. Patient satisfaction was high in both groups, rising from 0 to 2.5 on a scale of 0-4 at 1 month and 3.5 at 6 months. Patient satisfaction for the eight patients who did not have blepharoplasty was very similar.
There was no ectropion, infection, herpetic outbreaks, or hypopigmentation. Two patients developed postinflammatory hyperpigmentation, which resolved with hydroquinone 4%.
"This is an exciting new treatment with high patient satisfaction that can be done in a single treatment under local anesthesia. Traditional CO2 resurfacing may tighten the skin and reduce more rhytids than fractional resurfacing, but with the eCO2 laser, a physician can use the 1-mm spot size to do a traditional resurfacing if indicated," Dr. Woodward said.
The laser used in the study is on loan from the manufacturer, Lutronic Inc. Neither Dr. Woodward nor any of her coinvestigators accept remuneration from the company.
The Ceramic Flatiron: A Damage Causing Device
In a commentary in the January issue of the Journal of the American Academy of Dermatology, Dr. Paradi Mirmirani discussed the use of ceramic flatirons in Hispanic and African American women and acquired distal trichorrhexis nodosa sustained from repeated thermal injury (J. Am. Acad. Derm. 2010;62:145-7).
Trichorrhexis nodosa is an inherited or acquired hair shaft defect in which the hair is fragile and easily broken; on microscopic examination, filaments of the hair shaft are frayed like a broomstick.
Hot combs have been used for decades to straighten curly hair. Newer flatirons also provide temporary hair straightening, and are widely popular among women of every ethnic background. The uniform temperature distribution among the hair iron tongs allows the heat to temporarily break and reform the hydrogen bonds within the hair shaft.
In the process, the heat causes damage to the hair cuticle resulting in breakage and trichorrhexis nodosa.
Dr. Mirmirani, a dermatologist in Vallejo, Calif., noted that the ceramic coating of the metal in flatirons known as “thermal barrier coating,” decreases the impact of heat on the underlying metal (Annu. Rev. Materials Res. 2003;33:383–417), resulting in better heat distribution, retention, and transfer thought to result in “safer” heating of the hair.
However Dr. Mirmirani commented that although the ceramic-coated flatirons may be more efficient than metal ones, they result in more damage with improper use. Hair becomes dry, brittle, breaks easily and looks more untamed, leading to increased flatiron use to tame uneven hair.
Ceramic flatirons reach temperatures of up to 210° C which damages most hair, particularly chemically or color treated hair. African American hair which is extremely fragile and is often chemically relaxed, sustains significant damage with these high temperatures, and breakage occurs with repeated use of flatirons. Dr. Mirmirani counsels patients with trichorrhexis nodosa to avoid any heat or chemicals, to cut off the damaged hair, and to practice gentle hair care in order to minimize friction that can result in breakage.
Image courtesy Flickr user strangelibrarian (Creative Commons)
In a commentary in the January issue of the Journal of the American Academy of Dermatology, Dr. Paradi Mirmirani discussed the use of ceramic flatirons in Hispanic and African American women and acquired distal trichorrhexis nodosa sustained from repeated thermal injury (J. Am. Acad. Derm. 2010;62:145-7).
Trichorrhexis nodosa is an inherited or acquired hair shaft defect in which the hair is fragile and easily broken; on microscopic examination, filaments of the hair shaft are frayed like a broomstick.
Hot combs have been used for decades to straighten curly hair. Newer flatirons also provide temporary hair straightening, and are widely popular among women of every ethnic background. The uniform temperature distribution among the hair iron tongs allows the heat to temporarily break and reform the hydrogen bonds within the hair shaft.
In the process, the heat causes damage to the hair cuticle resulting in breakage and trichorrhexis nodosa.
Dr. Mirmirani, a dermatologist in Vallejo, Calif., noted that the ceramic coating of the metal in flatirons known as “thermal barrier coating,” decreases the impact of heat on the underlying metal (Annu. Rev. Materials Res. 2003;33:383–417), resulting in better heat distribution, retention, and transfer thought to result in “safer” heating of the hair.
However Dr. Mirmirani commented that although the ceramic-coated flatirons may be more efficient than metal ones, they result in more damage with improper use. Hair becomes dry, brittle, breaks easily and looks more untamed, leading to increased flatiron use to tame uneven hair.
Ceramic flatirons reach temperatures of up to 210° C which damages most hair, particularly chemically or color treated hair. African American hair which is extremely fragile and is often chemically relaxed, sustains significant damage with these high temperatures, and breakage occurs with repeated use of flatirons. Dr. Mirmirani counsels patients with trichorrhexis nodosa to avoid any heat or chemicals, to cut off the damaged hair, and to practice gentle hair care in order to minimize friction that can result in breakage.
Image courtesy Flickr user strangelibrarian (Creative Commons)
In a commentary in the January issue of the Journal of the American Academy of Dermatology, Dr. Paradi Mirmirani discussed the use of ceramic flatirons in Hispanic and African American women and acquired distal trichorrhexis nodosa sustained from repeated thermal injury (J. Am. Acad. Derm. 2010;62:145-7).
Trichorrhexis nodosa is an inherited or acquired hair shaft defect in which the hair is fragile and easily broken; on microscopic examination, filaments of the hair shaft are frayed like a broomstick.
Hot combs have been used for decades to straighten curly hair. Newer flatirons also provide temporary hair straightening, and are widely popular among women of every ethnic background. The uniform temperature distribution among the hair iron tongs allows the heat to temporarily break and reform the hydrogen bonds within the hair shaft.
In the process, the heat causes damage to the hair cuticle resulting in breakage and trichorrhexis nodosa.
Dr. Mirmirani, a dermatologist in Vallejo, Calif., noted that the ceramic coating of the metal in flatirons known as “thermal barrier coating,” decreases the impact of heat on the underlying metal (Annu. Rev. Materials Res. 2003;33:383–417), resulting in better heat distribution, retention, and transfer thought to result in “safer” heating of the hair.
However Dr. Mirmirani commented that although the ceramic-coated flatirons may be more efficient than metal ones, they result in more damage with improper use. Hair becomes dry, brittle, breaks easily and looks more untamed, leading to increased flatiron use to tame uneven hair.
Ceramic flatirons reach temperatures of up to 210° C which damages most hair, particularly chemically or color treated hair. African American hair which is extremely fragile and is often chemically relaxed, sustains significant damage with these high temperatures, and breakage occurs with repeated use of flatirons. Dr. Mirmirani counsels patients with trichorrhexis nodosa to avoid any heat or chemicals, to cut off the damaged hair, and to practice gentle hair care in order to minimize friction that can result in breakage.
Image courtesy Flickr user strangelibrarian (Creative Commons)