Hormonal treatment of acne: review of current best evidence.

BACKGROUND

Recent controlled clinical trials have demonstrated the efficacy of various hormonal preparations, including oral contraceptives, in treatment of acne.

OBJECTIVE

The goal of this article is to evaluate the best current evidence on the efficacy of hormonal treatment of acne.

METHODS

English-language controlled clinical trials of systemic hormonal treatment of acne were sought by search of references of general dermatology texts, reviews on acne, drug product monographs, and computer-assisted search of MEDLINE, CINAHL, and COCHRANE databases between 1970 and 2003 using the key words hormonal, oral contraceptive, acne, spironolactone, cyproterone, flutamide, and therapy. For each agent, studies fulfilling the highest level of evidence were selected for further evaluation.

RESULTS

The literature search recovered two placebo-controlled random controlled trials (RCTs) each of ethinyl estradiol 0.035 mg and norgestimate and ethinyl estradiol 20 microg and leonorgestrel 100 microg, three active-comparator RCTs of ethinyl estradiol 0.035 mg and cyproterone acetate 2 mg, one active comparator RCT of ethinyl estradiol 30 mug and drosperinone 3 mg, three small placebo-controlled RCTs of spironolactone, and one active-comparator RCT of flutamide.

CONCLUSIONS

The efficacy of Tri-Cyclen and Alesse in acne is supported by high-quality RCTs (level A evidence). Evidence for the efficacy of Diane-35, spironolactone, and flutamide is derived from lower-quality RCTs (level B evidence). Results from a population-based epidemiological study suggests that Diane-35 is the most effective of these oral contraceptives in the treatment of acne (level B evidence; epidemiological study).