FDA Accepts Application for Innovative Rosacea Treatment Gel

Rosacea is a common skin disorder in the United States and is identified by excessive redness of the skin, along with transient papules and pustules. This chronic skin condition affects about 14 million Americans and cause significant psychological and self-esteem problems if it is left untreated. Current rosacea treatments include Intense Pulsed Light therapy (IPL) and topical ointments. However, the FDA is currently reviewing a new drug by Sol-Gel Technologies that may offer multiple benefits for rosacea patients.

Sol-Gel has developed the DER45-EV Gel, a topical solution designed to enhance the efficacy and stability of topical drugs by creating a protective barrier between the drug and the skin. According to Dr. Stanley Shapiro, Sol-Gel’s Head of Skin Care Science and Technology, “As Sol-Gel’s microcapsulation forms a protective barrier between the drug and the skin, we expect it to reduce irritation when applied to the relatively sensitive skin of rosacea patients.”

The FDA has acknowledged receipt of this drug as an Investigational New Drug Application (IND) for the topical treatment of rosacea. People who were eligible for this study had to be 18 years of older, have facial rosacea with 15 or more inflammatory lesions, have moderate or severe ratings (a 3 or 4) of rosacea on the IGA, and could not have any allergies or sensitivities to ingredients in the test product. The gel was applied topically once per day to the facial area only for a course of 12 weeks. Women who were pregnant, breast feeding or planning pregnancy, and those with other dermatological conditions of the face were excluded from the trial.

The Sol-Gel study was first received on July 14, 2009 and is currently under review by the U.S. Food and Drug Administration. More information about the latest rosacea treatments and dermatologic solutions for patients with rosacea can be found here.

Further Reading