A randomized controlled trial of a low-dose combined oral contraceptive containing 3 mg drospirenone plus 20 [micro]g ethinylestradiol in the treatment of acne vulgaris: lesion counts, investigator Ratings and Subject Self-Assessment.

Journal of Drugs in DermatologyVol. 8 Nbr. 9, September 2009

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A randomized controlled trial of a low-dose combined oral contraceptive containing 3 mg drospirenone plus 20 [micro]g ethinylestradiol in the treatment of acne vulgaris: lesion counts, investigator Ratings and Subject Self-Assessment.

ABSTRACT

Objective: To assess the efficacy of a combined oral contraceptive (COC) containing 3 mg drospirenone (drsp) plus 20 [micro]g 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 [micro]g 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 [micro]g EE group than in the placebo group (P

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