title: Customized Single-agent Therapy Management of Severe Inflammatory Acne: A Randomized, Double-blind, Parallel-group, Controlled Study of a New Treatment--Adapalene 0.3%-Benzoyl Peroxide 2.5% Gel.
abstract: BACKGROUND
  More effective therapies are needed in the specific treatment of severe inflammatory acne vulgaris.
  
  
  OBJECTIVE
  To demonstrate superior efficacy of adapalene 0.3%-benzoyl peroxide 2.5% gel (0.3% A/BPO) vs. vehicle, and to assess efficacy of 0.3% A/BPO vs. 0.1% A/BPO in subjects with severe inflammatory acne (Investigator's Global Assessment [IGA] of 4) in the context of a larger trial in a moderate and severe population.
  
  
  METHODS
  This was a multicenter, randomized, double-blind, parallel-group, 12-week study. Subjects were randomized to receive 0.3% A/BPO, 0.1% A/BPO (benchmark) or vehicle (comparator) once daily for 12 weeks. Co-primary efficacy endpoints were success rate at week 12 (percentage of subjects rated "clear" or "almost clear," ≥ 3-grade IGA improvement), and change in inflammatory (IN) and noninflammatory (NIN) lesion counts from baseline to week 12. Secondary efficacy endpoints were percent changes in IN and NIN lesion counts. Safety endpoints were incidence of adverse events (AEs) and local tolerability signs/symptoms.
  
  
  RESULTS
  In the severe inflammatory acne population, a total of 252 subjects were randomized with 106, 112 and 34 subjects in the 0.3% A/BPO, 0.1% A/BPO and vehicle groups, respectively, reaching a high rate of study completion (88.5%). At week 12, both 0.3% A/BPO and 0.1% A/BPO were superior to vehicle in terms of lesion count reduction. However for success rate, only 0.3% A/BPO achieved significantly greater efficacy over vehicle with a treatment difference of 20.1% (31.9% vs. 11.8%; 95% Confidence Interval (CI): [6.0%, 34.2%], P=.029), whereas 0.1% A/BPO did not (treatment difference vs. vehicle of 8.8%; P=.443). This translates to an 11% difference between active treatments in favor of 0.3% A/BPO. Also, 0.3% A/BPO was safe and well tolerated.
  
  
  CONCLUSIONS
  Availability of this new treatment option should allow clinicians to better customize severe inflammatory acne management, and the high-strength product provides a step-up treatment when needed.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Weiss
authors.forename: Linda
authors.initials: L
authors.lastname: Stein Gold
authors.forename: Matthew
authors.initials: M
authors.lastname: Leoni
authors.forename: Maria Jose
authors.initials: MJ
authors.lastname: Rueda
authors.forename: Hong
authors.initials: H
authors.lastname: Liu
authors.forename: Emil
authors.initials: E
authors.lastname: Tanghetti
mesh_terms: D000152:Acne Vulgaris / Q000188:drug therapy*; D000068816:Adapalene / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000328:Adult; D001585:Benzoyl Peroxide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002626:Chemistry, Pharmaceutical; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006801:Humans; D007249:Inflammation / Q000188:drug therapy; D007641:Keratolytic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D003879:Dermatologic Agents; D004338:Drug Combinations; D007641:Keratolytic Agents; D000068816:Adapalene; D001585:Benzoyl Peroxide