A Randomized, Double-Blind, Placebo-Controlled Study Demonstrates Superior Skin Lightening Results With elure(TM) Compared to 2% Hydroquinone Cream
Syneron Medical Ltd. (NASDAQ: ELOS), the leading global aesthetic device company, announced today the publication of results from a clinical study evaluating the skin lightening efficacy and safety of its elure™ Advanced Skin Lightening product (lignin peroxidase cream) compared with 2% hydroquinone cream. The study, which demonstrated significantly faster and superior skin lightening results with elure, was published in the December 2011 issue of the peer-reviewed Journal of Cosmetic Dermatology. The Journal of Cosmetic Dermatology is the official journal of The International Academy of Cosmetic Dermatology (IACD).
The publication, which is titled "A Randomized and Placebo-Controlled Study to Compare the Skin Lightening, Efficacy, and Safety of Lignin Peroxidase Cream Versus 2% Hydroquinone Cream," is currently available on the journal's online website. The single-center, randomized, double-blind, placebo-controlled study included 51 patients, all of which were Asian women. Patients were randomized to receive day and night applications of elure Advanced Skin Lightening products on one randomly selected side of their face, and either 2% hydroquinone cream or placebo on the other side of their face.
The results from the study demonstrated a statistically significant change from baseline in the melanin index (as measured with optical instrumentation) on skin treated with elure Advanced Skin Lightening products, with a mean reduction of 7.6% (p < 0.001) on Day 31. Melanin is the molecule that accumulates in the skin to cause a darkened, pigmented or uneven skin tone. This compares to 2% hydroquinone cream and placebo, both of which did not provide a statistically significant change from baseline in the melanin index on Day 31. In addition, dermatologist scoring demonstrated a significant improvement in overall fairness as early as Day 8 on skin treated with elure Advanced Skin Lightening products, which was not observed on skin treated with 2% hydroquinone cream or placebo in the same timeframe.
Tess Mauricio, MD, founder of Scripps Ranch Dermatology & Cosmetic Center in San Diego, CA, and lead author of the study, said, "The results from this study not only demonstrate that elure is safe and efficacious, but that it represents a significant breakthrough in skin lightening technology. elure achieved a statistically significant reduction in melanin after one month, while hydroquinone, which was previously the most effective treatment option, did not. elure was also shown to be safe and well tolerated by patients in the study, providing additional benefits compared to the known side-effects of hydroquinone. In addition, some patients in the study achieved significant skin lightening results in as little as 8 days, which is attributable to the fact that elure's mechanism of action is to directly decompose melanin in the skin."
Louis P. Scafuri, Chief Executive Officer of Syneron Medical, said, "This first peer reviewed publication on elure confirms the strong early clinical and commercial results that patients have achieved with the product and further highlights its potential to become the gold standard for skin lightening and pigmentation treatments. We expect elure's clinical efficacy will be further confirmed upon the publication of several ongoing studies with global key opinion leaders on a variety of pigmentation disorders. We look forward to leveraging the excellent data published in the Journal of Cosmetic Dermatology, combined with other future publications on elure, to broaden awareness of the elure Advanced Skin Lightening product line."
About Syneron Medical Ltd.
Syneron Medical Ltd. (NASDAQ: ELOS) is the leading global aesthetic device company with a comprehensive product portfolio and a global distribution footprint. The Company's technology enables physicians to provide advanced solutions for a broad range of medical-aesthetic applications including body contouring, hair removal, wrinkle reduction, rejuvenation of the skin's appearance through the treatment of superficial benign vascular and pigmented lesions, and the treatment of acne, leg veins and cellulite. The Company sells its products under two distinct brands, Syneron and Candela. Founded in 2000, the corporate, R&D, and manufacturing headquarters for Syneron Medical Ltd. are located in Israel. Syneron also has R&D and manufacturing operations in the US. The Company markets, services and supports its products in 90 countries. It has offices in North America, France, Germany, Italy, Portugal, Spain, UK, Australia, China, Japan, and Hong Kong and distributors worldwide.
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