Epiduo (adapalene 0.1%/BPO 2.5%) has been approved by the FDA to treat acne in children as young as 9 years of age.
Epiduo was first approved in 2009 for the treatment of acne in patients 12 years of age and older. The new indication for the treatment of acne in children as young as 9 years of age is based on the results of a recent clinical study in pediatric patients, according to Galderma. The 12-week, multi-center, randomized, vehicle-controlled, double-blind study evaluated the safety and efficacy of Epiduo Gel in 285 acne patients between the ages of 9 and 11. Epiduo was shown to be safe and effective in a population of patients known to have more sensitive skin. Nearly 70% of parents with children in the treatment group reported improvement in their child’s acne, compared with only 23% of parents with children who were taking placebo.
The side effects reported in this trial were similar to those reported in the trial for patients 12 years and older and included a burning sensation, skin irritation and discomfort, dryness and erythema.
According to information from Galderma, until now, pediatricians and dermatologists did not have access to a prescription product that was approved for acne in this age group.
“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,” said Dr. Lawrence Eichenfield, Chief of Pediatric and Adolescent Dermatology at Rady Children’s Hospital, San Diego and at the University of California, San Diego. “Given the nature of acne, and its direct relationship to puberty and hormones, the focus of acne treatment has been on teenagers, leaving the younger age group with limited FDA-approved treatment options. 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.”
