title: Safety and efficacy of clindamycin phosphate 1.2%-benzoyl peroxide 3% fixed-dose combination gel for the treatment of acne vulgaris: a phase 3, multicenter, randomized, double-blind, active- and vehicle-controlled study.
abstract: BACKGROUND
  Topical fixed-combination therapy containing 1% clindamycin as 1.2% clindamycin phosphate (CLNP) and 3% benzoyl peroxide (BPO) is an effective treatment for acne vulgaris (acne).
  
  
  OBJECTIVE
  To demonstrate that the combination of 1.2% CLNP with lower strength BPO (CLNP 1.2%-BPO 3%) in a gel formulation is superior to each individual ingredient, CLNP 1.2% and BPO 3%, and vehicle gel.
  
  
  METHODS
  A total of 1,319 patients with acne, aged 12 years or older, were enrolled and randomized (1:1:1:1) to receive CLNP 1.2%-BPO 3%, CLNP 1.2% gel, BPO 3% gel, or vehicle gel once-daily in a 12-week, multicenter, double-blind, parallel-group, vehicle-controlled study. Subjects were evaluated at baseline, weeks 2, 4, 8, and 12 or early termination. Assessment of efficacy was evaluated using a six-point Investigator's Static Global Assessment (ISGA) and Subject's Global Assessment (SGA) of acne severity and lesion counts (inflammatory, non-inflammatory, and total). Safety assessments included skin tolerability and adverse events (AEs).
  
  
  RESULTS
  A greater proportion of subjects who used CLNP 1.2%-BPO 3% gel (39%) had a two grade improvement in ISGA from baseline to week 12 compared with CLNP 1.2% (25%; P<0.001), BPO 3% (30%; P=0.016), and vehicle (18%; P<0.001). CLNP 1.2%- BPO 3% was superior to CLNP 1.2% and vehicle alone in the absolute reduction from baseline to week 12 in all three lesion types (P<0.001 all pair-wise comparisons). CLNP 1.2%-BPO 3% was superior to BPO 3% alone in the absolute reduction from baseline to week 12 in inflammatory (P=0.015) and total (P=0.032) lesion counts. The incidence of product-related AEs was low and similar in all study groups (1% with CLNP 1.2%-BPO 3%, 2% with CLNP 1.2%, 2% with BPO 3%, and 2% with vehicle). Local tolerability assessments showed similar minimal changes from baseline to week 12 in all study groups.
  
  
  CONCLUSIONS
  CLNP 1.2%-BPO 3% gel provides superior efficacy to improve ISGA score and reduce inflammatory and total lesion counts compared with the individual active ingredients (CLNP 1.2% and BPO 3%) and vehicle, while maintaining a highly favorable safety and tolerability profile similar to BPO 3% alone.
authors: Rady Children's Hospital, San Diego, CA 92123-4204, USA. leichenfield@rchsd.org
authors: Lawrence F
authors: LF
authors: Eichenfield
authors: Alessandra B
authors: AB
authors: Alió Sáenz
mesh_terms: D000152:Acne Vulgaris / Q000188:drug therapy*; D000293:Adolescent; D000328:Adult; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001531:Belize; D001585:Benzoyl Peroxide / Q000009:adverse effects / Q000627:therapeutic use*; D002170:Canada; D002648:Child; D002981:Clindamycin / Q000009:adverse effects / Q000627:therapeutic use*; D003879:Dermatologic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005782:Gels; D006801:Humans; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D014481:United States; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D003879:Dermatologic Agents; D004338:Drug Combinations; D005782:Gels; C466951:clindamycin phosphate benzoyl peroxide combination; D002981:Clindamycin; D001585:Benzoyl Peroxide