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Vol. 203, No. 1, 2001
Issue release date: 2001
Dermatology 2001;203:38–44

Acne Resolution Rates: Results of a Single-Blind, Randomized, Controlled, Parallel Phase III Trial with EE/CMA (Belara®) and EE/LNG (Microgynon®)

Worret I. · Arp W. · Zahradnik H.-P. · Andreas J.-O. · Binder N.
aDepartment of Dermatology, University Hospital Munich, bTreatment Centre for Gynaecology and Obstetrics, Kiel, cDepartment of Gynaecology and Obstetrics, University Hospital Freiburg, and dGrünenthal GmbH, Aachen, Germany

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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®) for the treatment of mild to moderate papulopustular acne of the face and acne-related disorders in comparison to EE/levonorgestrel (LNG; Microgynon®). 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/CMAis 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.

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Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in goverment regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
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