An oral contraceptive containing ethinyl estradiol and drospirenone for the treatment of women with moderate acne vulgaris: a randomized, multicenter, placebo-controlled clinical trial

Objective To evaluate the efficacy and safety of an oral contraceptive containing ethinyl estradiol and drospirenone（YAZ）in the treatment of women with moderate acne vulgaris. Methods A multicenter, randomized, double-blind, placebo-controlled clinical trial was conducted. Totally, 179 female patients with moderate acne vulgaris were enrolled into this study from 7 research institutions in China, and randomly divided into YAZ group and placebo group by a random number table to be treated by oral YAZ and placebo respectively. In one cycle of treatment, patients administrated YAZ or placebo（one tablet once daily）from the 1st to 24th day of the menstrual cycle followed by a 4-day treatment with inactive tablets. All the patients received six cycles of treatment without a treatment-free interval. Efficacy and safety were evaluated according to the number of papules, pustules, nodules, open and closed comedones after 1, 3 and 6 cycels of treatment and within 8-15 days after the end of treatment. Results Finally, 173 patients were eligible for the full analysis set（FAS）, 146 completed the study, and 143 were eligible for the per protocol set（PPS）. After 6 cycles of treatment, the total number of lesions was meanly reduced by 66.8% and 37.3% in the YAZ group and placebo group respectively in the FAS, 72.6% and 55.6% respectively in the PPS. The number of inflammatory and noninflammatory lesions decreased by 75.5% and 69.3% in the YAZ group respectively after 6 cycles of treatment when compared to baseline, and by 60.9% and 50.2% in the placebo group respectively. The proportion of subjects rated as improved by investigators was 93.7%（74/79）in the YAZ group and 78.1%（57/73）in the placebo group. There were no serious adverse events in this study. The incidence rate of adverse reactions was 25.3%（22/87）in the YAZ group, and 4.7%（4/86）in the placebo group. Conclusion Six cycles of treatment with oral YAZ are effective and safe for female patients with moderate acne vulgaris. Trial registration number ClinicalTrials.gov Ref. No: NCT00818519. Key words: Acne vulgaris; Androgen antagonists; Randomized controlled trials; Ethinyl estradiol; Drospirenone; Contraceptive agents, female