FDA approves first topical acne treatment in children aged 9 and up

February 19, 2013

FDA has approved the topical acne drug adapalene 0.1%/benzoyl peroxide 2.5% (Epiduo, Galderma) in children ages 9 and older, according to a news release.

FDA has approved the topical acne drug adapalene 0.1%/benzoyl peroxide 2.5% (Epiduo, Galderma) in children ages 9 and older, according to a news release.

 

Epiduo had already been approved for acne treatment in children aged 12 years and older. FDA’s more recent approval was based on data from a 12-week, multicenter, randomized, vehicle-controlled, double-blind study of pediatric patients aged 9 to 11 years. The topical treatment was found to be safe and effective, with nearly 70% of patients demonstrating improvement in acne, compared to 23% in patients treated with placebo.

Common side effects reported in the study included dry skin, erythema, skin irritation and discomfort, and a skin burning sensation.

Treating a younger population with acne could help to prevent acne scarring in the future, researchers noted.