title: Sub-group Analyses from a Trial of a Fixed Combination of Clindamycin Phosphate 1.2% and Benzoyl Peroxide 3.75% Gel for the Treatment of Moderate-to-severe Acne Vulgaris.
abstract: BACKGROUND
  Acne vulgaris is commonplace and can be difficult to manage. Providing an effective and well-tolerated treatment may lead to improved adherence, increased patient satisfaction, and improved clinical outcomes.
  
  
  METHODS
  A review of efficacy, safety, and cutaneous tolerability of clindamycin phosphate 1.2%-benzoyl peroxide 3.75% gel in 498 patients with moderate-to-severe acne vulgaris enrolled in a multicenter Phase III study randomized to receive active or vehicle once daily for 12 weeks, including the most recent post-hoc analyses.
  
  
  RESULTS
  Significantly superior reductions in lesion counts were observed with clindamycin phosphate 1.2%-benzoyl peroxide 3.75% gel from Week 4, with median percent reductions in inflammatory and noninflammatory lesions from baseline of 68.4 and 57.9 percent, respectively (bothp<0.001 versus vehicle). More than half (55.1%) of the severe acne vulgaris patients treated with clindamycin phosphate 1.2%-benzoyl peroxide 3.75% gel achieved ≥2-grade improvement from baseline in their Evaluator's Global Severity Score, and almost a third of the adolescent acne vulgaris patients (32.4%) achieved at least a marked improvement in their acne vulgaris as early as Week 2. In adult female acne overall treatments success was achieved in 52.7 percent of patients treated with clindamycin phosphate 1.2%-benzoyl peroxide 3.75% gel. Overall, and in the specific subpopulations, clindamycin phosphate 1.2%-benzoyl peroxide 3.75% gel was well-tolerated with a similar adverse event profile to vehicle.
  
  
  CONCLUSIONS
  Post-hoc analyses from a single clinical trial with demographic imbalances that could potentially confound the results.
  
  
  CONCLUSIONS
  Clindamycin phosphate 1.2%-benzoyl peroxide 3.75% gel appears to be effective in treating acne across various clinically relevant sub-groups.
authors.affiliation: Gold Skin Care Center and Tennessee Clinical Research Center, Nashville, Tennessee;
authors.forename: Michael H
authors.initials: MH
authors.lastname: Gold
authors.affiliation: Valeant Pharmaceuticals North America LLC, Bridgewater, New Jersey.
authors.forename: Andrew
authors.initials: A
authors.lastname: Korotzer