There has been a marked increase in the use of oral contraceptives (OC) to treat acne vulgaris recent years. There is evidence in the literature to support this practice, but none of the previously published studies has been a double-blind, randomized, placebo-controlled trial. A placebo-controlled design is especially valuable in the assessment of acne treatments because patients participating in acne medication trials are likely to practice better skin hygiene and make more frequent physician office visits, thereby producing an unusually large placebo effect among study participants.
In this study, the effectiveness of a triphasic combination of norgestimate and ethinyl estradiol was evaluated for the treatment of acne vulgaris in a multicenter randomized, double-blind, placebo-controlled clinical trial. Two hundred fifty women ages 15 to 49, all of whom had moderate acne vulgaris, were enrolled in the study. Participants were randomized to groups receiving 6 months of OC therapy or 6 months of a color-matched placebo. For the OC group, treatment consisted of 3 consecutive weeks of active OC followed by 1 week of inactive drug (a regimen repeated six times); the control group received the placebo every week for the duration of the trial. Outcomes were measured using facial lesion counts, global assessment by the investigators, and patient self-evaluations. Hormone levels were also assessed.
One hundred sixty-four women completed the study with no significant departures from protocol. Among this group, those receiving OC treatment showed significantly greater improvement than placebo for all primary outcomes measures: 51.4 versus 34.6 percent mean reduction in inflammatory lesions (P = .01); 46.4 versus 33.9 percent mean reduction in total lesions (P = .001); 83.3 versus 62.5 percent on the investigator’s global assessment (P = .001). In the OC group, sex hormone-binding globulin levels rose significantly, although free testosterone decreased significantly; levels of both hormones remained unchanged in the placebo group. These findings affirm that a combination of norgestimate and ethinyl estradiol, administered in a triphasic regimen, is an effective treatment for moderate acne vulgaris in women who are candidates for OC therapy.
Obstet Gynecol 1997;89:615–622
Foundation for Developmental Endocrinology, Inc., Cleveland, Ohio