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Clinical Trial
. 2002 Sep;47(3):399-409.
doi: 10.1067/mjd.2002.122192.

Efficacy of a low-dose oral contraceptive containing 20 microg of ethinyl estradiol and 100 microg of levonorgestrel for the treatment of moderate acne: A randomized, placebo-controlled trial

James Leyden  1 , Alan Shalita, Maria Hordinsky, Leonard Swinyer, Frank Z Stanczyk, Margaret E Weber
Affiliations
Clinical Trial

Efficacy of a low-dose oral contraceptive containing 20 microg of ethinyl estradiol and 100 microg of levonorgestrel for the treatment of moderate acne: A randomized, placebo-controlled trial

James Leyden et al. J Am Acad Dermatol. 2002 Sep.

Abstract

Background: Acne is a multifactorial disease in which androgens appear to play an important role. A low-dose oral contraceptive containing 20 microg of ethinyl estradiol and 100 microg of levonorgestrel (EE/LNG) has been shown to improve biochemical markers of androgenicity. Lowering bioavailable androgens may improve acne.

Objective: The aim of this study was to evaluate the efficacy and safety of a low-dose oral contraceptive containing 20 microg of EE and 100 microg of LNG for the treatment of moderate acne.

Methods: In a randomized, double-blind, placebo-controlled clinical trial, healthy female subjects (n = 371; >/=14 years old) with regular menstrual cycles and moderate facial acne were randomly assigned to receive EE/LNG or placebo for 6 cycles of 28 days. Acne lesion counts and clinician global assessment were performed at the end of each cycle. Patient self-assessments were collected and biochemical markers of androgenicity were also measured.

Results: At the end of the study, the number of inflammatory and total lesions was significantly lower with EE/LNG compared with placebo (P <.05). Patients in the EE/LNG group also had significantly better scores for clinician global and patient self-assessments than those in the placebo group (P <.05). Biochemical markers of androgenicity improved during EE/LNG treatment compared with placebo and baseline values.

Conclusion: A low-dose oral contraceptive containing EE/LNG is effective and safe for the treatment of moderate acne.

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