title: Efficacy and Safety of Once-Daily Dapsone Gel, 7.5% for Treatment of Adolescents and Adults With Acne Vulgaris: First of Two Identically Designed, Large, Multicenter, Randomized, Vehicle-controlled Trials.
abstract: BACKGROUND
  Treatment of acne vulgaris (acne) with dapsone gel, 5% requires twice-daily dosing, and some patients may not adhere to this regimen.<br />
  
  
  OBJECTIVE
  The objective of this study was to assess the efficacy and safety of a new, once-daily formulation of dapsone gel, 7.5%, with a 50% higher dapsone concentration, versus vehicle over 12 weeks in patients with acne.<br />
  
  
  METHODS
  This 12-week, randomized, double-blind, vehicle-controlled, multicenter clinical trial enrolled patients with moderate acne aged 12 years and older with 20 to 50 inflammatory lesions and 30 to 100 noninflammatory lesions on the face, and an acne grade of 3 (moderate) on the Global Acne Assessment Score (GAAS). Patients were randomized to receive topical dapsone gel, 7.5% or vehicle once daily for 12 weeks. Investigators assessed GAAS success rate (proportion of patients with GAAS of 0 or 1) and percent change from baseline in inflammatory, noninflammatory, and total lesions.<br />
  
  
  RESULTS
  The intent-to-treat population comprised 2102 patients, 1044 in the dapsone gel, 7.5% group and 1058 in the vehicle group. At week 12, 29.9% of patients in the dapsone gel, 7.5% group and 21.2% in the vehicle group (P<.001) had GAAS success. Mean inflammatory lesions decreased by 55.5% and 49.0%, noninflammatory lesions decreased by 44.4% and 38.4%, and total lesions decreased by 48.7% and 42.4% in the dapsone gel, 7.5% and vehicle groups (all P<.001), respectively, at week 12. The incidence of adverse events was similar in the dapsone gel, 7.5% (19.1%) and vehicle (20.6%) groups. Most events in both groups were mild or moderate in severity. Most patients receiving dapsone gel, 7.5% and vehicle had a severity rating of "none" for stinging/burning, dryness, scaling, and erythema scales at all time points.<br />
  
  
  CONCLUSIONS
  Dapsone gel, 7.5% applied topically once daily is an effective, safe, and well-tolerated treatment for acne.<br /><br /> <em>J Drugs Dermatol</em>. 2016;15(5):553-561.
authors.forename: Linda F
authors.initials: LF
authors.lastname: Stein Gold
authors.forename: Michael T
authors.initials: MT
authors.lastname: Jarratt
authors.forename: Alicia D
authors.initials: AD
authors.lastname: Bucko
authors.forename: Steven K
authors.initials: SK
authors.lastname: Grekin
authors.forename: Joshua M
authors.initials: JM
authors.lastname: Berlin
authors.forename: Michael
authors.initials: M
authors.lastname: Bukhalo
authors.forename: Jonathan S
authors.initials: JS
authors.lastname: Weiss
authors.forename: David R
authors.initials: DR
authors.lastname: Berk
authors.forename: Joan-En
authors.initials: JE
authors.lastname: Chang-Lin
authors.forename: Vince
authors.initials: V
authors.lastname: Lin
authors.forename: Alexandre
authors.initials: A
authors.lastname: Kaoukhov
mesh_terms: D000152:Acne Vulgaris / Q000175:diagnosis* / Q000188:drug therapy*; D000293:Adolescent; D000328:Adult; D000890:Anti-Infective Agents / Q000008:administration & dosage* / Q000737:chemistry; D002648:Child; D003622:Dapsone / Q000008:administration & dosage* / Q000737:chemistry; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004339:Drug Compounding; D005260:Female; D005782:Gels; D006801:Humans; D008297:Male; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000890:Anti-Infective Agents; D005782:Gels; D003622:Dapsone