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New Horizons in Treating Disorders of Hyperpigmentation in Skin of Color
Sailesh Konda, MD, Aanand N. Geria, MD, and Rebat M. Halder, MD
Pigmentary abnormalities are among the most common reasons why patients with skin of color visit a dermatologist. Hydroquinone has been a cornerstone for the treatment of hyperpigmentation; however, concerns regarding adverse effects have prompted a search for alternative agents. Some promising topical treatments include soy, licorice, rucinol, mulberry, niacinamide, ellagic acid, resveratrol, and dioic acid. Oral agents, primarily used for the prevention of postprocedural hyperpigmentation, include procyanidins, tranexamic acid, and Polypodium leucotomos. Advances in Q-switched lasers, intense pulse light, fractional photothermolysis, and the advent of tretinoin peeling add to the clinician’s armamentarium for treating hyperpigmentation.
*For a PDF of the full article, click on the link to the left of this introduction.
Sailesh Konda, MD, Aanand N. Geria, MD, and Rebat M. Halder, MD
Pigmentary abnormalities are among the most common reasons why patients with skin of color visit a dermatologist. Hydroquinone has been a cornerstone for the treatment of hyperpigmentation; however, concerns regarding adverse effects have prompted a search for alternative agents. Some promising topical treatments include soy, licorice, rucinol, mulberry, niacinamide, ellagic acid, resveratrol, and dioic acid. Oral agents, primarily used for the prevention of postprocedural hyperpigmentation, include procyanidins, tranexamic acid, and Polypodium leucotomos. Advances in Q-switched lasers, intense pulse light, fractional photothermolysis, and the advent of tretinoin peeling add to the clinician’s armamentarium for treating hyperpigmentation.
*For a PDF of the full article, click on the link to the left of this introduction.
Sailesh Konda, MD, Aanand N. Geria, MD, and Rebat M. Halder, MD
Pigmentary abnormalities are among the most common reasons why patients with skin of color visit a dermatologist. Hydroquinone has been a cornerstone for the treatment of hyperpigmentation; however, concerns regarding adverse effects have prompted a search for alternative agents. Some promising topical treatments include soy, licorice, rucinol, mulberry, niacinamide, ellagic acid, resveratrol, and dioic acid. Oral agents, primarily used for the prevention of postprocedural hyperpigmentation, include procyanidins, tranexamic acid, and Polypodium leucotomos. Advances in Q-switched lasers, intense pulse light, fractional photothermolysis, and the advent of tretinoin peeling add to the clinician’s armamentarium for treating hyperpigmentation.
*For a PDF of the full article, click on the link to the left of this introduction.
Rejuvenation of the Lips and Lower Face [editorial]
Robotic-Assisted Follicular Unit Extraction for Hair Resotration: Case Reports
Duckless Lips: How to Rejuvenate the Older Lip Naturally and Appropriately
Technique for Facial Contour Correction With Autologous Fat Transfer
A 3-Tiered Approach for the Use of Calcium Hydroxylapatite Premixed with Lidocaine for Facial Applications
Soft Tissue Augmentation With Dermal Fillers, Part 1: Lips and Lower Face
Laser Treatment of Postprocedural Scars
U.S. Marshals Seize HybriSil Topical Steroid Gel
At the request of the Food and Drug Administration, U.S. Marshals seized an unapproved topical corticosteroid gel marketed by Crescendo Therapeutics.
The move was not entirely unexpected, as the FDA warned Crescendo in November 2011 that marketing of the drug, HybriSil (methylprednisolone acetate 1% in silicone gel), was illegal because it had never been approved and was being misbranded.
After the November warning, Crescendo responded to the FDA that it intended to file an investigational new drug (IND) application, according to the company president and CEO, Eric Glader. It made that filing in January 2012.
However, the FDA made a return inspection of Crescendo in late January and determined the company still was distributing the product for noninvestigational purposes. In early May, the FDA ordered Crescendo to discontinue manufacturing, and the company agreed.
The seizure was undertaken to ensure no more product would reach the market. The FDA said it has not received any reports of adverse reactions associated with HybriSil.
Mr. Glader said in an interview with Skin & Allergy News that Crescendo has begun clinical trials and intends to work with the agency to secure approval of a prescription HybriSil, and eventually, an over-the-counter version.
At the request of the Food and Drug Administration, U.S. Marshals seized an unapproved topical corticosteroid gel marketed by Crescendo Therapeutics.
The move was not entirely unexpected, as the FDA warned Crescendo in November 2011 that marketing of the drug, HybriSil (methylprednisolone acetate 1% in silicone gel), was illegal because it had never been approved and was being misbranded.
After the November warning, Crescendo responded to the FDA that it intended to file an investigational new drug (IND) application, according to the company president and CEO, Eric Glader. It made that filing in January 2012.
However, the FDA made a return inspection of Crescendo in late January and determined the company still was distributing the product for noninvestigational purposes. In early May, the FDA ordered Crescendo to discontinue manufacturing, and the company agreed.
The seizure was undertaken to ensure no more product would reach the market. The FDA said it has not received any reports of adverse reactions associated with HybriSil.
Mr. Glader said in an interview with Skin & Allergy News that Crescendo has begun clinical trials and intends to work with the agency to secure approval of a prescription HybriSil, and eventually, an over-the-counter version.
At the request of the Food and Drug Administration, U.S. Marshals seized an unapproved topical corticosteroid gel marketed by Crescendo Therapeutics.
The move was not entirely unexpected, as the FDA warned Crescendo in November 2011 that marketing of the drug, HybriSil (methylprednisolone acetate 1% in silicone gel), was illegal because it had never been approved and was being misbranded.
After the November warning, Crescendo responded to the FDA that it intended to file an investigational new drug (IND) application, according to the company president and CEO, Eric Glader. It made that filing in January 2012.
However, the FDA made a return inspection of Crescendo in late January and determined the company still was distributing the product for noninvestigational purposes. In early May, the FDA ordered Crescendo to discontinue manufacturing, and the company agreed.
The seizure was undertaken to ensure no more product would reach the market. The FDA said it has not received any reports of adverse reactions associated with HybriSil.
Mr. Glader said in an interview with Skin & Allergy News that Crescendo has begun clinical trials and intends to work with the agency to secure approval of a prescription HybriSil, and eventually, an over-the-counter version.
FDA Takes the Measure of Nanotechnology
The Food and Drug Administration is paying attention to the little things—the very little things. The FDA recently released guidelines for industry on the use of nanotechnology in food and cosmetics.
The draft guidelines have been issued for public comment, according to the FDA website.
The Nanodermatology Society issued a statement in response to the guidance for nanotechnology use in cosmetics—an issue that will continue to interest dermatologists as the technology evolves. The NDS stated its belief that the FDA has a responsibility to ensure the evaluation of nanomaterial use in cosmetics, including both over-the-counter and prescription products.
The guidelines must measure up to the science, however.
"The NDS believes that the guidelines should not be based on controversial evidence, weak evidence, or pure conjecture," according to the NDS statement.
To that end, the NDS pointed out a few areas of the guidelines where scientific evidence could be more complete. For example, with respect to titanium dioxide, the NDS notes that "TiO2 can accumulate in tissues such as kidneys, but can also be eliminated, for example, in the liver in some animal models." In addition, the NDS notes that a guideline proposing that penetration studies should be conducted on both intact and impaired skin might not be appropriate in cases where products are recommended for use on intact skin only.
In addition, the NDS recommended an expiration period for the final guidelines, due to the swift evolution of nanotechnology.
The draft guidance on the use of nanotechnology in cosmetic products is available on the FDA's website.
What's your take? Should the FDA monitor nanomaterials in cosmetic products?
–Heidi Splete (@hsplete on twitter)
The Food and Drug Administration is paying attention to the little things—the very little things. The FDA recently released guidelines for industry on the use of nanotechnology in food and cosmetics.
The draft guidelines have been issued for public comment, according to the FDA website.
The Nanodermatology Society issued a statement in response to the guidance for nanotechnology use in cosmetics—an issue that will continue to interest dermatologists as the technology evolves. The NDS stated its belief that the FDA has a responsibility to ensure the evaluation of nanomaterial use in cosmetics, including both over-the-counter and prescription products.
The guidelines must measure up to the science, however.
"The NDS believes that the guidelines should not be based on controversial evidence, weak evidence, or pure conjecture," according to the NDS statement.
To that end, the NDS pointed out a few areas of the guidelines where scientific evidence could be more complete. For example, with respect to titanium dioxide, the NDS notes that "TiO2 can accumulate in tissues such as kidneys, but can also be eliminated, for example, in the liver in some animal models." In addition, the NDS notes that a guideline proposing that penetration studies should be conducted on both intact and impaired skin might not be appropriate in cases where products are recommended for use on intact skin only.
In addition, the NDS recommended an expiration period for the final guidelines, due to the swift evolution of nanotechnology.
The draft guidance on the use of nanotechnology in cosmetic products is available on the FDA's website.
What's your take? Should the FDA monitor nanomaterials in cosmetic products?
–Heidi Splete (@hsplete on twitter)
The Food and Drug Administration is paying attention to the little things—the very little things. The FDA recently released guidelines for industry on the use of nanotechnology in food and cosmetics.
The draft guidelines have been issued for public comment, according to the FDA website.
The Nanodermatology Society issued a statement in response to the guidance for nanotechnology use in cosmetics—an issue that will continue to interest dermatologists as the technology evolves. The NDS stated its belief that the FDA has a responsibility to ensure the evaluation of nanomaterial use in cosmetics, including both over-the-counter and prescription products.
The guidelines must measure up to the science, however.
"The NDS believes that the guidelines should not be based on controversial evidence, weak evidence, or pure conjecture," according to the NDS statement.
To that end, the NDS pointed out a few areas of the guidelines where scientific evidence could be more complete. For example, with respect to titanium dioxide, the NDS notes that "TiO2 can accumulate in tissues such as kidneys, but can also be eliminated, for example, in the liver in some animal models." In addition, the NDS notes that a guideline proposing that penetration studies should be conducted on both intact and impaired skin might not be appropriate in cases where products are recommended for use on intact skin only.
In addition, the NDS recommended an expiration period for the final guidelines, due to the swift evolution of nanotechnology.
The draft guidance on the use of nanotechnology in cosmetic products is available on the FDA's website.
What's your take? Should the FDA monitor nanomaterials in cosmetic products?
–Heidi Splete (@hsplete on twitter)