title: Efficacy and Safety of Once-Daily Dapsone Gel, 7.5% for Treatment of Adolescents and Adults With Acne Vulgaris: Second of Two Identically Designed, Large, Multicenter, Randomized, Vehicle-Controlled Trials.
abstract: BACKGROUND
  Dapsone gel, 5% is administered twice daily for the treatment of acne vulgaris, and some patients may find adherence challenging.<BR />
  
  
  OBJECTIVE
  The study objective was to assess the efficacy and safety, compared with vehicle, of acne treatment with a recently FDA-approved, once-daily formulation of dapsone gel, 7.5%, with a 50% greater concentration of dapsone.<BR />
  
  
  METHODS
  This 12-week, randomized, double-blind, vehicle-controlled, multicenter clinical trial enrolled patients aged 12 years and older with 20-50 facial inflammatory lesions, 30-100 facial noninflammatory lesions, and an acne grade of 3 (moderate) on the Global Acne Assessment Score (GAAS). Patients were randomized (1:1 ratio) to topical dapsone gel, 7.5% or vehicle once daily for 12 weeks. Investigators assessed GAAS success rate (proportion of patients with a GAAS of 0 or 1) and percent change from baseline in inflammatory, noninflammatory, and total lesions.<BR />
  
  
  RESULTS
  The intent-to-treat population comprised 2238 patients (1118 in the dapsone gel, 7.5% group and 1120 in the vehicle group). The GAAS success rates were 29.8% for the dapsone gel, 7.5% group and 20.9% for the vehicle group (<em>P</em>&lt;0.001) at week 12. At week 12, mean inflammatory lesions decreased from baseline by 53.8% and 47.3%, noninflammatory lesions decreased by 45.9% and 40.4%, and total lesions decreased by 48.9% and 43.2% for the dapsone gel, 7.5% group and the vehicle group, respectively (all, <em>P</em>&lt;0.001). The incidence of treatment-emergent adverse events was similar for dapsone gel, 7.5% (17.6%) and vehicle (17.1%). Most adverse events were mild to moderate in severity. The most frequently reported increase in severity for all of the dermal tolerability scales was from "none" to "mild."<BR />
  
  
  CONCLUSIONS
  Dapsone gel, 7.5% applied topically once daily is an effective, safe, and well-tolerated treatment for acne vulgaris. Improvements in acne severity and lesions were observed over the 12-week course of treatment.<BR /><BR /> <em>J Drugs Dermatol</em>. 2016;15(8):962-969.
authors.forename: Lawrence F
authors.initials: LF
authors.lastname: Eichenfield
authors.forename: Ted
authors.initials: T
authors.lastname: Lain
authors.forename: Ellen H
authors.initials: EH
authors.lastname: Frankel
authors.forename: Terry M
authors.initials: TM
authors.lastname: Jones
authors.forename: Joan-En
authors.initials: JE
authors.lastname: Chang-Lin
authors.forename: David R
authors.initials: DR
authors.lastname: Berk
authors.forename: Shiling
authors.initials: S
authors.lastname: Ruan
authors.forename: Alexandre
authors.initials: A
authors.lastname: Kaoukhov
mesh_terms: D000152:Acne Vulgaris / Q000175:diagnosis* / Q000188:drug therapy*; D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D002648:Child; D003622:Dapsone / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004337:Drug Carriers / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D005782:Gels; D006261:Headache / Q000139:chemically induced; D006801:Humans; D008297:Male; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D004337:Drug Carriers; D005782:Gels; D003622:Dapsone