Epiduo Receives New Indication for Patients 9-Years-Old and Older, Launches Adherence Program for Those 13+


March 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 statement, Lawrence Eichenfield, MD, 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 hormones. “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.

Galderma also recently announced its new Epiduo TAP (Treatment, Adherence, and Performance) Program, an online and mobile patient platform that educates acne patients ages 13 and older about the proper application of Epiduo gel (adapalene 0.1% and benzoyl peroxide 2.5%) and encourages acne patients to stay adherent to treatment through an interactive and integrated performance-based platform. Through the program’s incentive-based system, patients are coached to follow their daily skincare regimen via text and email reminders. These reminders may help patients stay more compliant with their treatment, which could improve treatment outcomes, and help prevent future breakouts. For more information about Epiduo and the TAP Program, visit www.epiduo.com.

The Epiduo TAP program is intended for patients 13 and older.



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Practical Dermatology is the monthly publication that provides coverage of medical care, cosmetic advancements, and practice management for clinicians in the field. With straight-forward, how-to advice from experts in various fields, we strive to enhance quality of care and improve the daily operation of dermatology practices.