The duration of response to norgestimate and ethinyl estradiol in the treatment of acne vulgaris

Objective-This was a postmarketing, retrospective, exploratory analysis to investigate the duration of response to a triphasic combination oral contra ceptive (OC) (Ortho Tri-Cyclen(R); Ortho-McNeil Pharmaceutical, Raritan, NJ ) [norgestimate-ethinyl estradiol]) in the treatment of moderate acne vulga ris. Procedures-Healthy women with moderate acne vulgaris were enrolled in two 6-month, multicenter, randomized, double-blind, placebo-controlled clin ical trials. Subjects received either 3 weeks of active OC treatment (i.e., 0.035 mg ethinyl estradiol plus increasing doses of norgestimate [0.180 mg , 0.215 mg, 0.250 mg]) and 1 week of inactive tablets, or 4 weeks of color- matched placebo tablets. Results-A total of 507 subjects were enrolled in t he study. Duration of response was analyzed in subjects with at least sligh t improvement in global progress of treatment from the earliest cycle showi ng response (n = 305) and in subjects with at least slight improvement at o r before cycle 3 (n = 276); the duration of response was statistically sign ificant in favor of the norgestimate-ethinyl estradiol group in both cases (P less than or equal to .001). The variability of mean percent change in l esions was also statistically significantly greater in the placebo group th an in the OC group for total lesions (P less than or equal to .001) and inf lammatory lesions (P less than or equal to .001). Conclusion-A triphasic co mbination of norgestimate and ethinyl estradiol lengthens the time interval to recurrence of acne lesions.