Worret, I.; Arp, W.; Zahradnik, H. P.; Andreas, J. O.; Binder, N. (2001): Acne resolution rates: Results of a single-blind, randomized, controlled, parallel phase III trial with EE/CMA (Belara (R)) and EE/LNG (Microgynon (R)). In: Dermatology, Nr. 1: S. 38-44




Background and Objective: Acne in women can often be successfully treated by the intake of oral contraceptives containing gestagens with anti-androgenic properties. This study aimed to evaluate the efficacy of the monophasic oral contraceptive ethinylestradiol/chlormadinone acetate (EE/CMA; Belara (R)) for the treatment of mild to moderate papulopustular acne of the face and acne-related disorders in comparison to EE/levonorgestrel (LNG; Microgynon (R)). Methods: 199 female acne patients were enrolled in a single-blind, randomized, multicentre phase III study and divided into two groups who received either EE/CMA or EE/LNG. The primary end point was fulfilled if the number of papules/pustules per half of the face present on admission had decreased by at least 50% in the 12th medication cycle. Results: 59.4% of the women under EE/CMA and 45.9% under EE/LNG were responders. The relative frequency of women with complete resolution was 16.5% under EE/CMA and 4.3% under EE/LNG at cycle 12. Conclusion: EE/CMA is an efficient treatment for women with mild and moderate papulopustular acne of the face and related disorders, reflecting the well-known anti-androgenic properties of the progestogen CMA. Copyright (C) 2001 S, Karger AG, Basel.