Cyproterone Acetate Versus Levonorgestrel Combined with Ethinyl Estradiol in the Treatment of Acne: Results of a multicenter study

Abstract

In spite of an abundant literature on antiandrogen treatment with cyproterone acetate (CA) there have been no objectively measured results to prove statistically the possible superiority of CA over combined oral contraceptive pills in the treatment of acne vulgaris. A multicenter study was therefore done, in which two preparations containing CA in combination with ethinylestradiol (EE) were compared with a marketed combined oral contraceptive pill. The preparations studied were: 1) CA 2 mg + EE 50μg (Diane^R), 2) CA 2 mg + EE 35 μg (Diane^R mite), 3) Levonorgestrel 150 μg + EE 30 μg (Neovletta^R). A woman was eligible for the study if she was found by a dermatologist to have at least eight acne lesions (sum of papules, pustules, cysts and nodules) on her face, was otherwise healthy and without medication. After a primary assessment of the number of acne lesions by the dermatologist the woman was referred to a gynecologist and given one of the three test preparations double-blind and at random. The treatment was to continue for 6 months. 133 women were recruited at eight different centers. The groups thus constituted were of similar size and comparable with regard to age, degree of acne, and menstrual and contraceptive histories. As the number of acne lesions varied considerably between patients all data were converted into percentage change during treatment before they were processed in a computer. After only 4 months of treatment the patients on Diane^R and Diane^R mite had a significantly greater reduction in the number of acne lesions compared with those on Neovletta^R. This difference was more pronounced at the end of the sixth treatment cycle, where there was an average reduction of acne lesions by 70% in the Diane^R and Diane^R mite groups, compared with 35% in the Neovletta^R group. Furthermore, the data scatter was less for the two Diane^R groups. Among women taking Diane^R or Diane^R mite, only 4% were found to have deteriorated, as compared with 18% for Neovletta^R. The data support the previously unproven concept that regular oral contraceptive pills may improve acne in some women, whereas in others the condition was exacerbated. Bleeding patterns and contraceptive efficacy were excellent for all three preparations. Side effects were few and comparable to reports on other low-dose oral contraceptives. Diane^R mite had a tendency towards less pronounced “estrogenic” side effects and was equally effective in the treatment of acne as Diane^R. Diane^R mite is therefore suggested as the treatment of choice in women with acne who are otherwise willing to use an oral contraceptive.