Efficacy of a combined oral contraceptive containing 0.030 mg ethinylestradiol/2 mg dienogest for the treatment of papulopustular acne in comparison with placebo and 0.035 mg ethinylestradiol/2 mg cyproterone acetate

Palombo-Kinne, Ernesta; Schellschmidt, Ilka; Schumacher, Ulrike; Gräser, Thomas

doi:10.1016/j.contraception.2008.10.010

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Volume 79, Issue 4 , Pages 282-289, April 2009

Efficacy of a combined oral contraceptive containing 0.030 mg ethinylestradiol/2 mg dienogest for the treatment of papulopustular acne in comparison with placebo and 0.035 mg ethinylestradiol/2 mg cyproterone acetate☆

Received 30 April 2008; received in revised form 20 October 2008; accepted 20 October 2008. published online 17 December 2008.

Abstract

Background

Acne is a multifactorial disease characterized by androgenic stimulation of sebaceous glands. Therefore, combined oral contraceptives (COCs) containing anti-androgenic progestogens are suitable candidates for acne treatment. This study aimed to show that a COC containing the anti-androgen dienogest (DNG) is superior to placebo and not inferior to a COC containing the potent anti-androgen cyproterone acetate (CPA) in improving mild to moderate acne.

Study Design

Healthy women between 16 and 45 years old with mild to moderate facial acne were randomly assigned to receive ethinylestradiol (EE)/DNG (n=525), EE/CPA (n=537) or placebo (n=264) for six cycles in a multinational, multicenter, three-arm, double-blind and randomized trial. The primary efficacy variables were the percentages of change (from baseline to cycle 6) in inflammatory and total lesion count and the percentage of patients with acne improvement according to the Investigator Global Assessment.

Results

All primary analyses proved that EE/DNG was superior to placebo and non-inferior to EE/CPA (p<.05). For inflammatory lesions, the reduction (±SD) rates were −65.6±29.9% for EE/DNG, −64.6±31.2% for EE/CPA and −49.4±41.0% for placebo. For total lesions, the reduction rates were −54.7±26.3% for EE/DNG, −53.6±27.5% for EE/CPA and −39.4±33.6% for placebo. The percentages of patients with improvement of facial acne were 91.9% for EE/DNG, 90.2% for EE/CPA and 76.2% for placebo.

Conclusion

EE/DNG was superior to placebo, in spite of the prominent placebo effects, and as effective as EE/CPA in the treatment of mild to moderate acne, thus proving a valid option for the treatment of acne in women seeking oral contraception.

Keywords: Acne, Skin, Oral contraceptives, Dienogest, Cyproterone acetate, Valette, Diane 35, Randomized clinical trial