Efficacy and safety of 3 mg drospirenone/20 mcg ethinylestradiol oral contraceptive administered in 24/4 regimen in the treatment of acne vulgaris: a randomized, double-blind, placebo-controlled trial

William Koltun, Anne W. Lucky, Diane Thiboutot, Minoo Niknian, Carole Sampson-Landers, Paul Korner, Joachim Marr

Research output: Contribution to journalArticle

67 Scopus citations

Abstract

Background: A randomized, double-blind, parallel-group study to investigate the efficacy and safety of the 3 mg drospirenone (drsp)/20 mcg ethinylestradiol (EE) combined oral contraceptive (COC) administered in a 24/4 regimen (24 active tablets and 4 inert tablets per cycle) for the treatment of moderate acne vulgaris. Study Design: Healthy females (aged 14-45 years old) with moderate facial acne were randomized to 3 mg drsp/20 mcg (n=266) or placebo (n=268) for six cycles of 28 days. Results: Women who received the 3 mg drsp/20 mcg EE 24/4 COC had greater reductions from baseline in inflammatory, noninflammatory and total lesion counts. The odds of women in the 3 mg drsp/20 mcg EE 24/4 regimen COC group having 'clear' or 'almost clear' skin as rated by the investigators at end point was about fourfold greater than that in the placebo group (odds ratio 4.31; 95% CI: 2.11-9.60; p=.001). The 3 mg drsp/20 mcg EE 24/4 regimen COC was well tolerated and had a safety profile consistent with low-dose COC use. Conclusion: The 3 mg drsp/20 mcg EE 24/4 regimen COC was significantly more effective than placebo in treating moderate acne vulgaris.

Original languageEnglish (US)
Pages (from-to)249-256
Number of pages8
JournalContraception
Volume77
Issue number4
DOIs
StatePublished - Apr 1 2008

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All Science Journal Classification (ASJC) codes

  • Reproductive Medicine
  • Obstetrics and Gynecology

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