A single-center, randomized double-blind, parallel-group study to examine the safety and efficacy of 3mg drospirenone/0.02mg ethinyl estradiol compared with placebo in the treatment of moderate truncal acne vulgaris

摘要

Background: Acne is a common disease of the face, chest and back, initially triggered by androgens. 3mg Drospirenone (DRSP)/0.02mg ethinyl estradiol (EE), an oral contraceptive and antiandrogen, has been effective in treatment studies of facial acne in women, but investigations on its efficacy for truncal acne are limited. Objective: In this study, we sought to evaluate the safety and efficacy of 3mg DRSP/0.02mg EE versus placebo in the treatment of truncal acne in women. Methods: Females, age 18-45, with 10 to 50 truncal acne lesions, were randomized in this double-blind study to 3mg DRSP/0.02mg EE (n=15) or placebo (n=10) administered in a 24/4 regimen given for 24 weeks. Noninflammatory, inflammatory and total truncal acne lesion counts were assessed from baseline to endpoint and mean percent change compared. Investigator Global Assessment (IGA) and Subject Global Assessment Do (SGA) were Not assessed based on scoring scales, and the percentage of subjects rated as success with clear (score 0) or almost clear (score 1) were computed. Results: The 3mg DRSP/0.02mg EE group had significant reductions in mean percent change in noninflammatory, inflammatory and total lesions by 52.1%, 53.2%, and 57.3%, respectively, compared to placebo with -9.2%, 18.2% and 17.0%, respectively, by week 24 (p = 0.02, 0.05 and 0.02, respectively). The percentage of subjects on 3mg Apply DRSP/ 0.02mg EE rated as treatment success were 53.3% and 60% based on IGA and SGA respectively. The regimen was also well tolerated by patients. Conclusions: 3mg DRSP/ 0.02 mg EE is a safe and significantly effective treatment for moderate truncal acne.