A Randomized Controlled Trial of a Low-Dose Combined Oral ContraceptiveContaining 3 mg Drospirenone Plus 20 μg Ethinylestradiol in the Treatment of AcneVulgaris: Lesion Counts, Investigator Ratings and Subject Self-Assessment

September 2009 | Volume 8 | Issue 9 | Original Article | 837 | Copyright © September 2009

J. Michael Maloney MD, Peter Dietze Jr. MD, David Watson MD, Minoo Niknian PhD,Sooji Lee-Rugh MD, Carole Sampson-Landers MD, Paul Korner MD MBA

Abstract
Objective: To assess the efficacy of a combined oral contraceptive (COC) containing 3 mg drospirenone (drsp) plus 20 μg ethinylestradiol (EE) administered in 24 days of active treatment followed by a four-day hormone-free interval (24/4 regimen) compared with placebo for the treatment of moderate acne vulgaris.

Methods: Healthy females (14–45 years old) with moderate facial acne were randomized to 3 mg drsp/20 μg EE 24/4 (n=270) or placebo (n=268) for six cycles. The secondary efficacy variables measured included change from baseline to endpoint (cycle 6) in individual lesion count for nodules, papules, pustules, open and closed comedones.

Results: There were significantly greater reductions in individual lesion counts from baseline to endpoint in the 3 mg drsp/20 μg EE group than in the placebo group (P<0.05 from parametric model).

Conclusion: The 3 mg drsp/20 μg EE COC administered in a 24/4 regimen significantly reduced acne lesions.