Efficacy of an oral contraceptive containing 0.030mg ethinylestradiol and 2mg dienogest (EE/DNG) for the treatment of acne – Comparison with placebo and with 0.035mg ethinylestradiol / 2mg cyproterone acetate (EE/CPA)

TR Gräser, Ernesta Palombo‐Kinne, Ilka Schellschmidt
In: Geburtshilfe und Frauenheilkunde · 2008 · vol. 68(S 01) · doi:10.1055/s-0028-1089030 · W2320529667
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This study compared the efficacy of an oral contraceptive containing ethinylestradiol and dienogest against placebo and against ethinylestradiol and cyproterone acetate for treating acne.

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This multicenter, double-blind, double-dummy randomized clinical trial evaluated whether an oral contraceptive containing ethinylestradiol/dienogest (EE/DNG) is non-inferior to ethinylestradiol/cyproterone acetate (EE/CPA) and superior to placebo for treating mild to moderate papulopustular acne in healthy women aged 16–45 over 6 cycles (28 days each). Primary outcomes were percent change in inflammatory and total lesion counts and the proportion of patients with facial acne improvement by investigator global assessment (IGA). EE/DNG showed significant superiority versus placebo and non-inferiority versus EE/CPA, with inflammatory lesion reductions of about 65.6% (EE/DNG) vs 64.6% (EE/CPA) vs 49.4% (placebo) and facial acne improvement rates of 91.9% (EE/DNG) vs 90.2% (EE/CPA) vs 76.2% (placebo). The study’s caveat is that it was conducted in a specific population with mild to moderate acne. The paper does not explicitly discuss endometriosis or adenomyosis; it was included in the corpus via a keyword match in the upstream search index.

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Abstract

Introduction: Papulopustular acne is a common skin disease characterized, beside other factors, by androgenic stimulation of sebaceous glands. Combined oral contraceptives (COC) containing progestins with anti-androgenic properties (including e.g. dienogest [DNG]) are therefore suitable for the treatment of acne. The aim of this study was to show the non-inferiority of EE/DNG compared to EE/CPA (a well-established hormonal anti-acne treatment), and the superiority of EE/DNG compared to placebo.
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Introduction

Papulopustular acne is a common skin disease characterized, beside other factors, by androgenic stimulation of sebaceous glands. Combined oral contraceptives (COC) containing progestins with anti-androgenic properties (including e.g. dienogest [DNG]) are therefore suitable for the treatment of acne. The aim of this study was to show the non-inferiority of EE/DNG compared to EE/CPA (a well-established hormonal anti-acne treatment), and the superiority of EE/DNG compared to placebo.

Methods

In a multicenter, double-blind, double-dummy, randomized clinical trial, healthy women between 16 and 45 years of age and with mild to moderate papulopustular acne were randomly assigned to receive EE/DNG (n=525), EE/CPA (n=537), or placebo (n=264) for 6 cycles of 28 days. The primary efficacy variables consisted of percent change (baseline to cycle 6) in inflammatory and total lesion counts, and percent of patients with improvement in facial acne according to the investigator global assessment (IGA).

Results

In the intent-to-treat population, all primary efficacy analyses proved the superiority of EE/DNG compared to placebo and the non-inferiority of EE/DNG compared to EE/CPA (p<0.05). For inflammatory lesions, the reduction was 65.6±29.9% (SD) for EE/DNG, –64.6±31.2% for EE/CPA, and –49.4±41.0% for placebo. For total lesions, the reduction was 54.7±26.3% for EE/DNG, 53.6±27.5% for EE/CPA, and 39.4±33.6% for placebo. The proportion of patients with improvement of facial acne (IGA) was 91.9% for EE/DNG, 90.2% for EE/CPA, and 76.2% for placebo. Thus, EE/DNG was as effective in the treatment of mild to moderate papulopustular acne as EE/CPA, known to be effective also in more severe acne. Acne - Skin - Oral contraceptives - Dienogest - Cyproterone acetate - Valette - Diane 35 - Randomized clinical trial

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