OSCAR phase IV study of Epiduo Forte shows impact on moderate-to-severe acne.- Galderma.

Galderma has announced positive results from OSCAR, a phase IV trial, a multicenter, randomized, investigator-blinded, vehicle-controlled, intra-individual comparison study (right/left half-face) of Epiduo Forte (adapalene and benzoyl peroxide). The purpose of OSCAR was to evaluate the efficacy of Epiduo Forte (adapalene and benzoyl peroxide) Gel, 0.3%/2.5% in the treatment of moderate-to-severe acne and to understand if, by decreasing active acne lesions, Epiduo Forte Gel could thereby decrease the risk of atrophic (depressed) acne scars. The OSCAR results were published in the American Journal of Clinical Dermatology.

Results demonstrated 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, by rapidly and effectively treating acne, Epiduo Forte Gel also reduced the risk of atrophic acne scars in patients with moderate-to-severe acne. 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. 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).