Phase III Data Show Galderma's Topical Redness Reducer is Effective, Safe

Topical brimonidine tartrate gel 0.5% is safe and effective for the management of erythema of rosacea, with benefit evidence as early as 30 minutes after application, new data show. (JDD, 12(6):650-656) Data from two identically designed randomized, double-blind, vehicle controlled phase III trials showed that Galderma's investigational topical brimonidine gel applied once-daily was significantly more efficacious than vehicle gel throughout 12 hours on days 1, 15, and 29. The trials recruited subjects with moderate to severe erythema of rosacea, who were randomized 1:! to active treatment or vehicle control. Patients applied brimonidine 0.5% once-daily. Evaluations included the Clinician's Erythema Assessment and Patient's Self-Assessment. Adverse events were mostly dermatological, mild, and transient, with a slightly higher incidence of adverse events in the active treatment group. Brimonidine tartrate gel 0.5% is under FDA review.