Cited by 96Acne and Rosacea Treatments and EffectsReproductive Health and ContraceptionOvarian function and disorders

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

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Thiboutot, Diane, Archer, David F, Lemay, André, Washenik, Ken, Roberts, Janet, Harrison, Diane D·2001·Fertility and Sterility

Abstract

Objective To evaluate the efficacy of a low-dose oral contraceptive (OC) containing 100 microg of levonorgestrel (LNG) and 20 microg 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 (> or =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 microg of EE and 100 microg 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 microg of EE and 100 microg of LNG is an effective and safe treatment for moderate acne.

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  • In three randomized trials, a larger percentage of patients receiving combined oral contraceptives than vehicle achieved Investigator's Global Assessment success at the end of cycle 6 (RR 1.45, 95% CI 1.06-1.97).

    “Compared to vehicle at the end of cycle 6, a greater proportion of patients treated with COCs achieved IGA success in 3 RCTs (RR, 1.45 [1.06, 1.97]).”

    From Guidelines of care for the management of acne vulgaris (2024) · cites this paper as [131]

    The Clinician Global and Patient Self-Assessments section reports that, at cycle 6, clinicians rated 57.9% of the contraceptive group and 46.7% of the placebo group clear or almost clear; Statistical Analyses defines that rating as treatment success. The paper reports one trial, not a three-trial result, and does not report the stated RR of 1.45 or its confidence interval. Page numbers were not available in our copy. (LLM, conf=0.88)

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  • In nine randomized trials, combined oral contraceptives produced greater reductions in inflammatory lesion counts than vehicle at the end of cycle 6 (mean difference in percentage change from baseline -15.81%, 95% CI -20.44% to -11.17%).

    “Greater reductions in both inflammatory (MD in the percentage change from baseline, À15.81% [À20.44%,À11.17%])”

    From Guidelines of care for the management of acne vulgaris (2024) · cites this paper as [131]

    The Lesion Counts section and Table 3 report a greater reduction in inflammatory lesions with LNG/EE than with placebo at cycle 6. But this paper reports one trial, not nine; its reported mean percentage changes are −46.8% and −32.6%, not the claimed pooled mean difference of −15.81% with a 95% CI. (LLM, conf=0.88)

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Research works printed but not linked: 1

  1. [4]4. Centers for Disease Control and Prevention, National Center for Health Statistics. Number of selected reported chronic conditions per 1,000 persons, by age, United States, 1995. Vital Health Stat 10 1995;199: 77-8.

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Authors
Thiboutot, D., Archer, D. F., Lemay, A., Washenik, K., Roberts, J., & Harrison, D. D.
Affiliations
  • Pennsylvania State University (US)
  • Centre hospitalier universitaire de Québec (CA)
  • NYU Langone Health (US)
Corresponding author
Harrison, Diane D
Venue
Fertility and Sterility
Publisher
Elsevier BV
Published
2001-09
Volume
76
Issue
3
Pages
461-468
ISSN
0015-0282 (ISSN-L)
OpenAlex
W2150038365
Cited by
96
References
21
Citations by year
2025: 2 · 2024: 3 · 2022: 1 · 2021: 1 · 2020: 1 · 2019: 1 · 2018: 1 · 2017: 3 · 2016: 3 · 2015: 4 · 2014: 4 · 2013: 5 · 2012: 5
FWCI
6.29
Type
journal article
Language
en
Open access
Locations
  • Fertility and Sterility (publishedVersion)
  • PubMed (publishedVersion)
Funders
Baylor University
Topics
  • Health Sciences › Medicine › Dermatology › Acne and Rosacea Treatments and Effects
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Reproductive Health and Contraception
  • Health Sciences › Medicine › Reproductive Medicine › Ovarian function and disorders
Keywords
acne, low-dose oral contraceptives, ethinyl estradiol, levonorgestrel, acne treatment, acne lesion count, patient self-assessment, weight change, blood pressure, women
MeSH terms
Acne Vulgaris, Adolescent, Adult, Blood Pressure, Body Weight, Contraceptives, Oral, Combined, Double-Blind Method, Ethinyl Estradiol, Female, Humans, Middle Aged, Placebos, Surveys and Questionnaires, Levonorgestrel

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