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 © June 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.
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 personâ€™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 (YazÂ® 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-