Galderma Laboratories announced that the FDA has approved Epiduo (adapalene and benzoyl peroxide) Gel for the treatment of acne in children as young as 9 years old. Epiduo, a retinoid and antibacterial/keratolytic combination, had been previously approved for patients >12 years old.

The FDA approval is based on data from a recently completed 12-week multicenter, randomized, vehicle-controlled, double-blind pediatric study that evaluated the safety and efficacy of Epiduo Gel in 285 patients aged 9–11 years. Results showed that nearly 70% of parents with children in the Epiduo treatment group saw improvement in their child’s acne vs. 23% of parents with children in the placebo group.

Epiduo Gel is available in a 45g tube and 45g pump.

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