title: Comparative efficacy and tolerability of dapsone 5% gel in adult versus adolescent females with acne vulgaris.
abstract: OBJECTIVE
  To determine whether the response to dapsone 5% gel was similar in adolescent girls and adult women with facial acne vulgaris.
  
  
  METHODS
  Subgroup analysis of female subjects with acne vulgaris receiving active treatment enrolled in two randomized, double-blind Phase 3 clinical trials.
  
  
  METHODS
  Twice-daily applications of dapsone 5% gel over 12 weeks.
  
  
  METHODS
  Adolescent (12-17 years of age) and adult (≥18 years of age) females.
  
  
  METHODS
  At baseline and at Weeks 2,4,6,8, and 12, subjects were evaluated using the global acne assessment score and by counts of inflammatory, noninflammatory, and total acne vulgaris lesions. Adverse events were monitored.
  
  
  RESULTS
  A total of 347 adolescent and 434 adult women were included in the subgroup analysis. At Week 12, dapsone 5% gel significantly reduced mean global acne assessment score in both subgroups (p<0.001); however, the proportion of subjects with clinical success (no or minimal acne based on global acne assessment score) at Week 12 was greater in adult women (53.5%) versus adolescent females (45.3%, p=0.022). Significantly greater percentage reductions in both noninflammatory (p<0.0001) and total lesion counts (p=0.0008) were observed in the adult group as compared to the adolescent group. Percentage reductions from baseline in inflammatory lesions were similar in both groups. No major safety issues and no previously unrecognized safety signals were noted.
  
  
  CONCLUSIONS
  This subgroup analysis of female patients indicates that dapsone 5% gel twice daily is effective in reducing inflammatory and noninflammatory acne vulgaris lesions in both adolescent and adult women, and is safe in these subgroups. Overall, these data suggest that efficacy of dapsone 5% gel twice daily for facial acne vulgaris may be greater in the adult female population.
authors.affiliation: Touro University College of Osteopathic Medicine, Henderson, Nevada; Las Vegas Skin and Cancer Clinics/West Dermatology Group, Henderson, Nevada;
authors.forename: James Q
authors.initials: JQ
authors.lastname: Del Rosso
authors.affiliation: Mount Sinai Medical Center, New York, New York; Indiana University School of Medicine, Indianapolis, Indiana; Physicians Skin Care PLLC, Louisville, Kentucky;
authors.forename: Leon
authors.initials: L
authors.lastname: Kircik
authors.affiliation: Medical Affairs, Allergan, Inc., Irvine, California.
authors.forename: Conor J
authors.initials: CJ
authors.lastname: Gallagher