Epiduo approved for children ages 9 and up

February 19, 2013

The Food and Drug Administration has approved the topical acne drug Epiduo (adapalene 01. percent/benzoyl peroxide 2.5 percent, Galderma) in children ages 9 and older, according to a news release.

 

The Food and Drug Administration has approved the topical acne drug Epiduo (adapalene 01. percent/benzoyl peroxide 2.5 percent, Galderma) in children ages 9 and older, according to a news release.

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