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Acne improvement in young women using a low-dose triphasic oral contraceptive containing gestodene and ethinylestradiol (Tri-Minulet ® ). Interim evaluation of an open non-controlled clinical study combined with objective biometrological methods

1996; Informa; Volume: 10; Issue: sup5 Linguagem: Inglês

10.3109/09513599609049610

1473-0766

Gérald Pierard, Nazli Nikkels‐Tassoudji, V. Goffin, U Gaspard, Patricia Slachmuylders, P. Lacante,

Hormonal and reproductive studies

The effects of gestodene in a triphasic combination with size of comedones. The investigators' and patients' global ethinylestradiol (Tri-Minulet®) on mild to moderate acne assessments of severity of acne both demonstrated improve- were studied in 25 healthy young women over six treatments after treatment cycles in an open-label, non-comparative, single- of sex hormone binding globulin were increased at all center study. A decrease in the mean total lesion count of 11.9 lesions (95% CI 5.4 to 18.5)from a mean baseline value of 26.1 lesions was observed at cycle 6, with the number of papules being the most reduced. The mean overall severity of acne grade was reduced by 0.8 points (95% CI 0.3 to 1.3). A trend towards reduction of sebum production was also observed. Cyanoacrylate skin surface strippings revealed a reduction in the number and size of comedones. The investigators' and patients' global assessments of severity of acne oboth demons demonstrated improvements after treatment (binomial test p < 0.001).Levels of sex homone binding globlin were increased at all visits, and levels of progesterone, androstenedione and androstanediol glucuronide were reduced after treatment. No patient was withdrawn from the study because of adverse events. It was concluded that treatment with gestodene and ethinylestradiol in a triphasic formulation for six treatment cycles was well tolerated and produced a trend to obvious improvement in mild to moderate acne.