A Combined Oral Contraceptive Containing 3-mg Drospirenone/20-µg Ethinyl Estradiol in the Treatment of Acne Vulgaris: A Randomized, Double-blind, Placebo-Controlled Study Evaluating Lesion Counts and Participant Self-assessment

This study compared the efficacy of a low-dose combined oral contraceptive (COC) containing 3-mg drospirenone and 20-µg ethinyl estradiol (3-mg DRSP/20-µg EE) administered in a 24-day active pill/4-day inert pill (24/4) regimen and placebo in women with moderate acne vulgaris during 6 treatment cycles. A total of 534 participants were randomized and dispensed study medication (n=266 [3-mg DRSP/20-µg EE 24/4 regimen COC group]; n=268 [placebo group]). Women of reproductive age were eligible for inclusion in the study. Treatment with the 3-mg DRSP/20-µg EE 24/4 regimen COC was associated with a greater reduction from baseline to end point in individual lesion counts (papules, pustules, open and closed comedones) compared with placebo. The mean nodule count remained essentially constant throughout the study and was low in both treatment groups. There was a significantly higher probability that a participant had an improved assessment on the investigator's overall improvement rating scale (odds ratio [OR], 4.02; 95% CI [confidence interval], 2.29–7.31; P