The approval was based on the positive results of a 12-week multicenter, randomized, vehicle-controlled, double-blind pediatric study, which enrolled 285 acne sufferers aged 9 to 11 years.
The study demonstrated that Epiduo is safe and effective in the younger population known to have more sensitive skin.
In addition, the study reported that the results demonstrated in the pediatric clinical study were similar to those observed in prior Phase 3 clinical studies which included patients 12 years of age and older.
The company said the pediatric study also reported similar common side effects, as demonstrated in prior Phase 3 clinical studies for patients 12 years and older, 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 pediatricians 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 9 years old, pediatricians and dermatologists now have a safe and effective treatment for children with early acne," Eichenfield added.
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."