EFFECTIVENESS OF NORGESTIMATE AND ETHINYL ESTRADIOL IN TREATING MODERATE ACNE-VULGARIS

Background: An excess of androgen is believed to contribute to develop ment of acne in some patients. Because oral contraceptives (OCs) may r educe the active androgen level, hormonal therapy with OCs has been us ed successfully to treat patients with acne, although this treatment h as previously not been studied in placebo-controlled trials. Objective : Our purpose was to evaluate the efficacy of a triphasic, combination OC (ORTHO TRI-CYCLEN [Ortho-McNeil Pharmaceutical, Raritan, N.J.], no rgestimate/ ethinyl estradiol) compared with placebo in the treatment of moderate acne vulgaris. Methods: Two hundred fifty-seven healthy fe male subjects, 15 to 49 years of age with moderate acne vulgaris, were enrolled in a multicenter, randomized, double-blind, placebo-controll ed clinical trial. Each month for 6 months, subjects received either 3 consecutive weeks of the OC (i.e., tablets containing a fixed dose of ethinyl estradiol [0.035 mg] and increasing doses of norgestimate [0. 180 mg, 0.215 mg, 0.250 mg]) followed by 7 days of inactive drug or pl acebo (color-matched tablets). Efficacy was assessed by facial acne le sion counts, an investigator's global assessment, a subject's self-ass essment, and an analysis of within-cycle variation (cycle 6) in lesion counts. Results: Of the 160 subjects in whom efficacy could be evalua ted, the OC group showed a statistically significantly greater improve ment than the placebo group for all primary efficacy measures. The mea n decrease in inflammatory lesion count from baseline to cycle 6 was 1 1.8 (62.0%) versus 7.6 (38.6%) (p = 0.0001), and the mean decrease in total lesion count was 29.1 (53.1%) versus 14.1 (26.8%) (p = 0.0001) i n the OC and placebo groups, respectively. In the investigator's globa l assessment, 93.7% of the active treatment group versus 65.4% of the placebo group were rated as improved at the end of the study (p < 0.00 1). Six of the seven secondary efficacy measures (total comedones, ope n comedones, closed comedones, papules, pustules, and the subject's se lf-assessment of study treatment) were also significantly more favorab le in the OC group compared with the placebo group. Conclusion: An OC containing 0.035 mg of ethinyl estradiol combined with the triphasic r egimen of norgestimate is a safe and effective treatment of moderate a cne vulgaris in women with no known contraindication to OC therapy.