February 22, 2006

SkinMedica has reported the results of two Phase III clinical trials evaluating Desonate (desonide) HydroGel 0.05 percent, a low-potency topical steroid formulated in a proprietary alcohol-free, aqueous gel delivery vehicle to treat atopic dermatitis.

The studies were conducted as a multicenter, randomized, double-blind, placebo-controlled comparison involving pediatric subjects with mild to moderate atopic dermatitis. These clinical trials included 582 patients from age 3 months to 18 years, and were designed to demonstrate superiority of Desonate HydroGel over vehicle (placebo) without desonide. Patients received either Desonate HydroGel or placebo twice daily for four weeks.

The results of these two studies demonstrated a consistently robust and highly statistically significant treatment effect for Desonate compared to placebo in both primary and secondary endpoints. These included the alleviation of signs and symptoms of atopic dermatitis, including erythema, induration/papulation, and scaling. The proportion of patients achieving treatment success using the IGSA primary end-point was 44 percent for Desonate HydroGel and 14 percent for the vehicle group in the first trial. In the second trial, treatment success rates were 28 percent for Desonate HydroGel and 6 percent for the vehicle group.