The US Food and Drug Administration (FDA) has approved Galderma Laboratories’ Epiduo (adapalene 0.1% / BPO 2.5%) gel for the treatment of acne in children as young as nine.
The approval was based on the positive results of a 12-week multicentre, randomised, vehicle-controlled, double-blind paediatric study, which enrolled 285 acne sufferers aged nine to 11 years.
The study demonstrated that Epiduo is safe and effective in the younger population, which has more sensitive skin.
Nearly 70% of parents with children in the Epiduo gel treatment group saw improvement in their child’s acne compared to 23% of parents with children on placebo, according to the company
The study also reported that the results demonstrated in the paediatric clinical study were similar to those observed in prior Phase III clinical studies, which included patients aged 12 and over.
The paediatric study reported similar common side effects to previous studies, including skin burning sensation, skin irritation, skin discomfort, dry skin and erythema.
Rady Children’s Hospital pediatric and adolescent dermatology chief Dr Lawrence Eichenfield said paediatricians and dermatologists are seeing a steady increase in children reaching puberty at an earlier age and, consequently, many children are dealing with acne sooner than traditionally observed.
"With Epiduo gel’s newly approved age indication starting at nine years old, paediatricians and dermatologists now have a safe and effective treatment for children with early acne," Eichenfield said.
Galderma Laboratories president Francois Fournier said; "Galderma has always been dedicated to providing physicians with innovative acne solutions, and the new label for Epiduo gel underscores our dedication to the dermatology community."