FDA Approves Topical Cream for Inflammatory Rosacea

The FDA approved benzoyl peroxide 5% cream (Epsolay) for adults with inflammatory lesions of rosacea. The medication uses silica-based microcapsules that create a barrier between the skin and active ingredient, and is designed to slowly release benzoyl peroxide over time to provide a favorable efficacy and safety profile.

The FDA approved benzoyl peroxide 5% cream based on data from two 12-week phase 3 trials with 733 adult participants with rosacea randomized to either benzoyl peroxide or a vehicle solution. Benzoyl peroxide–treated patients had a 70% reduction in inflammatory lesions from baseline after 12 weeks of treatment versus 38% to 46% for those who received vehicle without active ingredient.

Benzoyl peroxide 5% cream can cause photosensitivity, so patients should be advised to avoid sun while using this medication. Consult product labeling for important safety and prescribing information.

Benzoyl peroxide 5% cream is a product of Sol-Gel Technologies and will be marketed by Galderma.