New Phase 4 Data: Epiduo Forte Gel Decreased Acne Lesions, Reduced Risk of Scars

Results from OSCAR, a Phase 4, multicenter, randomized, investigator-blinded, vehicle-controlled, intra-individual comparison study (right/left half-face), revealed that Epiduo Forte (adapalene and benzoyl peroxide) Gel 0.3%/2.5% not only decreased acne lesions, as measured over a period of 24 weeks, but also reduced the risk of atrophic acne scars in patients with moderate-to-severe acne.  The OSCAR results were published in the American Journal of Clinical Dermatology.

Results demonstrated Galderma's Epiduo Forte Gel significantly decreased acne lesions, as measured over a period of 24 weeks vs. vehicle, with acne lesion reduction as early as week one. At week 24, a significantly larger percentage of subjects were Investigator's Global Assessment (IGA) clear/almost clear with Epiduo Forte Gel treatment (64.2 percent vs. 19.4 percent vehicle). Furthermore, through the effective reduction of acne lesions, the overall Scar Global Assessment (SGA) also improved by week 24 in the portion of the face treated with Epiduo Forte Gel (32.9 percent clear/almost clear vs. 16.4 percent vehicle). According to a patient satisfaction survey, overall, 90.1 percent were satisfied to very satisfied with Epiduo Forte Gel vs. 59 percent with vehicle.

"Acne scarring impacts approximately 40 percent of people who currently have acne.While significant advances have been made in treating acne, there is an unmet need to understand how we can best reduce the risk of acne scarring," says Jerry Tan, MD, fellowship certified specialist in dermatology and adjunct professor, Schulich School of Medicine and Dentistry, Department of Medicine, University of Western Ontario, principal investigator of the OSCAR trial, and paid Galderma consultant. "Results from the OSCAR study show that treating acne lesions early and effectively with Epiduo Forte Gel can reduce the risk of atrophic acne scars."

"We are pleased to share these positive findings that underscore the efficacy and tolerability of Epiduo Forte Gel in the treatment of acne," says Chris Chapman, Vice President and General Manager of Galderma's U.S. Prescription Business. "We hope that the learnings from the OSCAR study will help empower clinicians to view scar risk reduction as a key consideration within the acne treatment paradigm.^"

In the study, Epiduo Forte Gel was safe and well tolerated with the most common treatment-related adverse event (AE) being mild to moderate skin irritation (15 percent vs. six percent, vehicle). There were no serious or severe AEs in the study, and the vast majority of related AEs were mild in intensity.