• J Drugs Dermatol · Sep 2009

    Randomized Controlled Trial

    A randomized controlled trial of a low-dose combined oral contraceptive containing 3 mg drospirenone plus 20 microg ethinylestradiol in the treatment of acne vulgaris: lesion counts, investigator ratings and subject self-assessment.

    • J Michael Maloney, Peter Dietze, David Watson, Minoo Niknian, Sooji Lee-Rugh, Carole Sampson-Landers, and Paul Korner.
    • Cherry Creek Research, Inc, Denver, CO 80209, USA. Drmaloney@cherrycreekdermatology.com
    • J Drugs Dermatol. 2009 Sep 1; 8 (9): 837-44.

    ObjectiveTo assess the efficacy of a combined oral contraceptive (COC) containing 3 mg drospirenone (drsp) plus 20 microg 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.MethodsHealthy females (14-45 years old) with moderate facial acne were randomized to 3 mg drsp/20 microg 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.ResultsThere were significantly greater reductions in individual lesion counts from baseline to endpoint in the 3 mg drsp/20 microg EE group than in the placebo group (P < 0.05 from parametric model).ConclusionThe 3 mg drsp/20 microg EE COC administered in a 24/4 regimen significantly reduced acne lesions.

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