A randomized, controlled trial of a low-dose contraceptive containing 20 μg of ethinyl estradiol and 100 μg of levonorgestrel for acne treatment

Diane Thiboutot, David F. Archer, André Lemay, Ken Washenik, Janet Roberts, Diane D. Harrison

Research output: Contribution to journalArticlepeer-review

91 Scopus citations

Abstract

Objective: To evaluate the efficacy of a low-dose oral contraceptive (OC) containing 100 μg of levonorgestrel (LNG) and 20 μg of ethinyl estradiol (EE) compared with placebo for the treatment of moderate acne. Design: Multicenter, randomized, double-blind, placebo-controlled clinical trial. Setting: Outpatient dermatology clinics.Patient(s): Women (≥14 years old; n = 350) with normal menstrual cycles and moderate acne were randomized to receive LNG/EE or placebo for six cycles. Intervention(s): Twenty μg of EE and 100 μg of LNG. Main Outcome Measure(s): Acne lesion counts and clinician global assessment were performed at baseline and at each cycle. Patient self-assessment was carried out at baseline and at cycles 4 and 6; blood pressure and weight were measured at baseline and at cycles 1, 3, and 6. Result(s): Inflammatory, noninflammatory, and total lesion counts at cycle 6 with LNG/EE were significantly lower compared to placebo. Patients in the LNG/EE group also had significantly better clinician global and patient self-assessment scores than those in the placebo group at cycle. Changes in weight from baseline were similar between patients in the LNG/EE and placebo groups at all measured time points. Conclusion(s): This double-blind, placebo-controlled study demonstrates that a low-dose OC containing 20 μg of EE and 100 μg of LNG is an effective and safe treatment for moderate acne.

Original languageEnglish (US)
Pages (from-to)461-468
Number of pages8
JournalFertility and sterility
Volume76
Issue number3
DOIs
StatePublished - 2001

All Science Journal Classification (ASJC) codes

  • Reproductive Medicine
  • Obstetrics and Gynecology

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