title: An aqueous gel fixed combination of clindamycin phosphate 1.2% and benzoyl peroxide 3.75% for the once-daily treatment of moderate to severe acne vulgaris.
abstract: OBJECTIVE
  To evaluate efficacy, safety, and tolerability of a fixed combination clindamycin phosphate 1.2% and benzoyl peroxide 3.75% (clindamycin-BP 3.75%) aqueous gel in moderate to severe acne vulgaris.
  
  
  METHODS
  A total of 498 patients, 12-40 years of age, were randomized to receive clindamycin-BP 3.75% or vehicle in a double-blind, controlled 12-week, 2-arm study evaluating safety and efficacy using inflammatory and noninflammatory lesion counts, Evaluator Global Severity Scores (EGSS) and subject self-assessment (SSA). In addition, patients completed a patient satisfaction survey (PSS), acne-specific QoL questionnaire, and assessed their facial skin for shininess/oiliness.
  
  
  RESULTS
  Clindamycin-BP 3.75% demonstrated statistical superiority to vehicle in reducing both inflammatory and noninflammatory lesions and acne severity. Clindamycin-BP 3.75% showed greater efficacy relative to vehicle in assessments of skin oiliness, SSA and PSS. No substantive differences were seen in cutaneous tolerability among treatment groups and no patients discontinued treatment with Clindamycin-BP 3.75% because of adverse events.
  
  
  CONCLUSIONS
  Data from controlled studies may differ from clinical practice. It is not possible to determine the contributions from the individual active ingredients.
  
  
  CONCLUSIONS
  Clindamycin-BP 3.75% provides statistically significant greater efficacy than vehicle with a favorable safety and tolerability profile.
authors.forename: David M
authors.initials: DM
authors.lastname: Pariser
authors.forename: Phoebe
authors.initials: P
authors.lastname: Rich
authors.forename: Fran E
authors.initials: FE
authors.lastname: Cook-Bolden
authors.forename: Andrew
authors.initials: A
authors.lastname: Korotzer
mesh_terms: D000152:Acne Vulgaris / Q000175:diagnosis* / Q000188:drug therapy*; D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D001585:Benzoyl Peroxide / Q000008:administration & dosage*; D002626:Chemistry, Pharmaceutical; D002648:Child; D002981:Clindamycin / Q000008:administration & dosage / Q000031:analogs & derivatives*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D005782:Gels; D006801:Humans; D008297:Male; D017060:Patient Satisfaction; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014867:Water; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D004338:Drug Combinations; D005782:Gels; D014867:Water; D002981:Clindamycin; C007084:clindamycin phosphate; D001585:Benzoyl Peroxide