Epiduo Approved For Patients as Young as 9-Years-Old

02/19/2013

Based on the results of a recent clinical study in pediatric patients, the FDA has approved Epiduo (adapalene 0.1%/BPO 2.5%, Galderma) Gel to treat acne in children as young as nine years old. In the 12-week multicenter, randomized, vehicle-controlled, double-blind study, investigators evaluated the safety and efficacy of Epiduo Gel in 285 acne sufferers aged nine to 11 years. Results indicated that nearly 70 percent of parents with children in the Epiduo Gel treatment group saw improvement in their child's acne, compared to only 23 percent of parents with children on placebo. Common reported side effects included skin burning sensation, skin irritation, skin discomfort, dry skin and erythema. In a press release, Dr. Lawrence Eichenfield, Chief of Pediatric and Asolescent Dermatology at Rady Children's Hospital in San Diego observed that this approval is key, particularly given the nature of acne and its relationship to puberty and hormons. “With Epiduo Gel's newly approved age indication starting at nine years old, pediatricians and dermatologists now have a safe and effective treatment for children with early acne," noted Dr. Eichenfield.

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