Sol-Gel gets go-ahead to initiate rosacea treatment studies

December 1, 2009

Washington - The Food and Drug Administration has acknowledged receipt of Sol-Gel’s Investigational New Drug Application (IND) for DER45-EV Gel for the topical treatment of rosacea, reports Medical News Today.

Washington

- The Food and Drug Administration has acknowledged receipt of Sol-Gel’s Investigational New Drug Application (IND) for DER45-EV Gel for the topical treatment of rosacea, reports Medical News Today.

The IND allows Sol-Gel, an Israel-based pharmaceutical firm, to initiate phase 2 studies with DER45-EV Gel in rosacea patients.

DER45-EV Gel is a topical product based on Sol-Gel’s patented drug-delivery system that is designed to enhance the efficacy, safety and stability of topical drugs. Sol-Gel’s technology does so by encapsulating the active ingredients in an inert, clear silica microcapsule shell that releases the ingredients in a time-controlled manner.

Rosacea is a common and chronic skin disorder. Affecting mainly fair-skinned, middle-aged and older adults, rosacea is characterized by transient or persistent erythema, papules and pustules. The condition affects more than 14 million Americans and can cause significant psychological, social and occupational problems if left untreated.

Medical News Today quotes Stanley Shapiro, M.D., Sol-Gel’s director of skincare science and technology, as saying, “Sol-Gel's microcapsulation forms a protective barrier between the drug and the skin, [and] we expect it to reduce irritation when applied to the relatively sensitive skin of rosacea patients.”