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Oral contraceptive regimen effective in improving moderate acne, data suggest

Thursday, October 30 2008 | Comments

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What's This? Acne in girls and women can be treated successfully with combined oral contraceptive pills (OCPs) containing 3 mg drospirenone and 20 mcg ethinyl estradiol, suggests a new study.

Funded by Bayer Schering Pharma AG, the double-blind, randomized, controlled trial included healthy females aged 14-45 years with moderate acne vulgaris. Participants in the treatment group (n=270) took a pill containing 3 mg drospirenone and 20 mcg ethinyl estradiol daily for 24 days, followed by 4 days of hormone-free pills, repeating this regimen for 6 cycles of 28 days. Participants in the placebo group (n=268) took a placebo pill daily for 6 cycles of 28 days.

In addition to assessments at baseline and upon randomization, the researchers evaluated participants at intervals, on approximately day 15 of cycles 1, 3, and 6, as well as at follow-up, 8-15 days after the last pill was taken. At treatment cycles 1, 3 and 6, they assessed acne lesion counts, Investigator Static Global Assessment (ISGA), compliance, adverse events, concomitant medications, and vital sign measurements.

The primary endpoints were percentage change from baseline in the number of inflammatory and noninflammatory lesion counts and percentage of participants classified as clear (ISGA score of 0) or "almost clear" (ISGA score of 1); an ISGA score of 5 was defined as having numerous inflammatory and noninflammatory acne lesions.

The OCP regimen tested in this study was recently approved by the Food and Drug Administration for the treatment of moderate acne vulgaris. The authors note that inclusion criterion for the full analysis set (used for the primary efficacy analysis) was amended according to FDA requirements to change the indication from mild to moderate acne to moderate acne. That change resulted in 218 participants in the treatment group and 213 in the placebo group. Of these, 86.2% of the treatment group (n=188) and 84.5% of the placebo group (n=180) were at least 80% compliant.

At baseline, the mean lesion count was similar in the combined OCP and placebo groups (31.7 and 31.8 for inflammatory lesions, 43.9 and 43.9 for noninflammatory lesions, and 75.7 and 75.7 for total lesions, respectively).

The percentage reduction from baseline to endpoint for total lesions was 46.3% for 3 mg drospirenone and 20 mcg ethinyl estradiol and 30.6% for the placebo group (P<.001). From baseline to cycle 3, the percentage reduction was statistically significant in inflammatory and total lesion counts in the OCP group compared with the placebo group (P<.05). Over the course of the study, there was also a significantly higher probability that the percentage of participants who had an ISGA score indicating "clear" or "almost clear" skin was greater in the combined OCP group than the placebo group (proportion = 21.1% in the OCP group and 8.9% in the placebo group). The resulting odds ratio indicated a 3-fold odds of achieving "clear" or "almost clear" skin for the OCP group (OR, 3.13; 95% CI, 1.69-5.81; P=.001).

The authors report that the treatment was generally well-tolerated, and its safety profile was comparable with that of other low-dose combined OCPs. (Jaloney JM, et al. Obstet Gynecol 2008;112:773-781.)

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