New Clinical Study on Women of Hispanic Descent Shows an Impressive 60% Improvement in the Appearance of Melasma
WESTLAKE VILLAGE, Calif., June 1, 2013 – Envy Medical, Inc., a leading developer and marketer of medical professional skincare devices and products, today announced the publication of a recently completed study on the efficacy of topically applied decapeptide-12, a Stanford University developed technology found exclusively in Lumixyl branded professional skincare, in combination with a buffered glycolic acid and a physical sunscreen (as formulated and dispensed under the Lumixyl Topical Brightening System brand).
The clinical study evaluating the efficacy of the Lumixyl Topical Brightening System, titled Open-Label Evaluation of a Novel Skin Brightening System Containing 0.01% Decapeptide-12 in Combination With 20% Buffered Glycolic Acid for the Treatment of Mild to Moderate Facial Melasma, was published in the June 2013 issue of the Journal of Drugs in Dermatology.
The study was led by Sandra P. Ramirez, MD, Academic Coordinator for the Scientific Association of Aesthetic Medicine in Colombia, along with a team of practicing dermatologists. It involved 33 healthy volunteer women of hispanic decent, over a 16 week evaluation period. Each volunteer was qualified as having mild to moderate melasma, a form of hyperpigmentation of the skin believed to occur due to hormonal and environmental factors. As the study notes, melasma is more common in women than men, and more common in women of Hispanic or Asian descent, although it can be found in individuals of every skin type.
The study showed significant improvement in the appearance of melasma in the volunteers,
according to an objective method of measuring hyperpigmentation severity. In fact, those measures revealed a 36% decrease in melasma in just the first four weeks alone. The visible presence of melasma continued to decrease about eight percent in each subsequent four-week measurement, resulting in an overall decrease in the appearance of melasma of 60% over the course of the 16 week study.
“One of the very impressive aspects of the study, is that it showed a constant rate of improvement for the population of patients throughout the course,” said Dr. Ramirez. “In other words, Lumixyl is shown to deliver consistent, significant improvements to overall skin tone, without rebounding, or resistance issues sometimes seen with traditional topical therapies.”
The published results build on the existing evidence that Lumixyl and it’s underlying peptide technology are safe and effective as an alternative to hydroquinone in addressing the varied forms of hyperpigmentation. Prior publications include a study lead by Dr. David Goldberg, MD, detailed in the Journal of Cosmetic and Laser Therapy, with 15 female volunteers of Asian and Caucasian descent, all with moderate to severe photodamage. That study also showed that 85 percent of the study volunteers achieved significantly or completely improved hyperpigmentation over 24 weeks, with standardized photos confirming the results.
Decapeptide-12 was developed by a team of dermatologists and researchers at Standford Universty, led by Basil Hantash, M.D. Ph.D. Their initial laboratory findings were published in the Journal of Investigative Dermatology, which showed that Decapaptide-12, part of a novel class of peptides in the study, was more potent in suppressing melanin production than hydroquinone, but at the same time, it was also shown to be completely non-cytotoxic. By comparison hydroquinone was shown to have a cytotoxic effect, interfering with the health of the individual melanin producing cells.
Dr. Ramirez’s study summary also informs the reader that, “Although HQ is one of the most effective and popular skin lightening compounds, it has been shown to cause irritant contact dermatitis (in up to 70% of patients), pregnancy-induced hypertension, hypopigmentation, and allergic contact dermatitis.”
And while hydroquinone is still widely sold and used, this latest study also notes that it is clear that there is a need for novel compounds that strike a balance between skin brightening efficacy and dermal/systemic toxicity.
The abstract of the study can be found at the JDD publication website by clicking here, along with instructions on purchasing the full report for personal review.
The Lumixyl Topical Brightening System is sold through the physician dispensed channel, and was first introduced commercially in 2010. It has since experienced steady growth in popularity as a front-line therapy for diminishing the appearance of hyperpigmentation, promoting healthy skin function and promoting an even skin-tone in over 30 countries worldwide. Based on its safety and efficacy, the peptide has also been formulated in a comprehensive under-eye dark circle correcter under the brand name Lumixyl Revitaleyes, and also more recently the company launched Lumixyl Topical Brightening Pads that provide the brightening peptide within a soothing non-woven pad for use with dry or irritated skin. For more information, visit www.envymedical.com
ABOUT ENVY MEDICAL — Envy Medical develops, markets and sells highly effective non-invasive skin rejuvenation therapies for patients suffering from either dermatologic or aesthetic conditions. The Company’s lead products include SilkPeel®, a breakthrough device combining exfoliation with Dermalinfusion® for deeper tissue delivery of active ingredients and better patient outcomes. Envy is also the exclusive licensor of skin brightening peptides including Lumixyl, developed at Stanford University. The Lumixyl peptide is now also available as a topical solution for SilkPeel procedures, addressing hyperpigmentation and photo-damage. More information can be found at www.envymedical.com.