title: A single-center, randomized double-blind, parallel-group study to examine the safety and efficacy of 3mg drospirenone/0.02 mg ethinyl estradiol compared with placebo in the treatment of moderate truncal acne vulgaris.
abstract: BACKGROUND
  Acne is a common disease of the face, chest and back, initially triggered by androgens. 3mg Drospirenone (DRSP)/0.02 mg 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.<BR>
  
  
  OBJECTIVE
  In this study, we sought to evaluate the safety and efficacy of 3mg DRSP/0.02 mg EE versus placebo in the treatment of truncal acne in women.<BR>
  
  
  METHODS
  Females, age 18-45, with 10 to 50 truncal acne lesions, were randomized in this double-blind study to 3mg DRSP/0.02 mg 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.<BR>
  
  
  RESULTS
  The 3mg DRSP/0.02 mg 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/ 0.02 mg EE rated as treatment success were 53.3% and 60% based on IGA and SGA respectively. The regimen was also well tolerated by patients.<BR>
  
  
  CONCLUSIONS
  3mg DRSP/ 0.02 mg EE is a safe and significantly effective treatment for moderate truncal acne.
authors.affiliation: Harvard Medical School and Department of Dermatology, Massachusetts General Hospital, Boston, MA, USA.
authors.forename: Ma Beatrice Alora
authors.initials: MB
authors.lastname: Palli
authors.forename: Claire Marie
authors.initials: CM
authors.lastname: Reyes-Habito
authors.forename: Xinaida T
authors.initials: XT
authors.lastname: Lima
authors.forename: Alexa B
authors.initials: AB
authors.lastname: Kimball
mesh_terms: D000152:Acne Vulgaris / Q000188:drug therapy* / Q000473:pathology; D000293:Adolescent; D000328:Adult; D000736:Androstenes / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003277:Contraceptives, Oral, Combined / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D004311:Double-Blind Method; D004997:Ethinyl Estradiol / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007249:Inflammation / Q000188:drug therapy / Q000473:pathology; D008875:Middle Aged; D012720:Severity of Illness Index; D060726:Torso; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000736:Androstenes; D003277:Contraceptives, Oral, Combined; C534342:drospirenone and ethinyl estradiol combination; D004997:Ethinyl Estradiol