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
June 2013 | Volume 12 | Issue 6 | Original Article | 633 | Copyright © 2013
Ma. Beatrice Alora Palli MD,a,b Claire Marie Reyes-Habito MD,b Xinaida T. Lima MD MPH,c and Alexa B. Kimball MD MPHa,b
aHarvard Medical School and Department of Dermatology, Massachusetts General Hospital, Boston, MA bClinical Unit for Research Trials and Outcomes in Skin (CURTIS), Massachusetts General Hospital, Boston, MA cDepartment of Dermatology, University of Campinas, Sao Paulo, Brazil
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 (SGA) were 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 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.
J Drugs Dermatol. 2013;12(6):633-637.
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Acne is a common skin disease characterized by comedones, papules, pustules, nodules and cysts usually on the face, chest, and back. Although most acne studies focus on facial acne, truncal acne may also affect a person’s self-esteem and body image. Acne is initially triggered by androgen hormones that drive changes in the sebocytes and follicular keratinocyte leading to excess sebum production and intrafollicular hypercornification and later comedone formation. The presence of Propionibacterium acnes and inflammation also further contributes to the pathogenesis of acne.1
Several topical medications may be used for acne such as retinoids, salicylic acid, clindamycin, erythromycin and benzoyl peroxide. Unfortunately, application of topical medications to the back may be difficult. Systemic treatments for acne, on the other hand, such as antibiotics of the tetracycline group and erythromycin may be used, but resistance to these antibiotics is becoming common. The use of isotretinoin, a systemic retinoid acne treatment, also tends to be more resistant in truncal acne. Energy based devices such as blue light, lasers, and photodynamic therapy may be used to target P. acnes and treat acne, but can be very costly.2
The use of hormonal treatment for acne, such as oral contraceptives and antiandrogens (eg spironolactone), counteract the effects of androgens on the sebaceous glands, which have been approved by the FDA for over ten years. Several randomized controlled trials have corroborated their efficacy and safety for acne in women of childbearing age. Most of these studies, however, focus on facial acne and ignore treatment outcomes in the chest and back.3-6
3mg Drospirenone/ 0.02mg ethinyl estradiol (Yaz® trademark of Bayer, USA) is a FDA approved oral contraceptive for treating acne vulgaris in women at least 14 years old who desire an oral contraceptive for birth control. Unlike other progestins, drospi-