title: A randomized, parallel, vehicle-controlled comparison of two erythromycin/benzoyl peroxide preparations for acne vulgaris.
abstract: BACKGROUND
  Topical erythromycin/benzoyl peroxide (EBP), marketed for acne treatment, must be compounded by a pharmacist and requires subsequent refrigeration, warranting the development of alternate formulations.
  
  
  OBJECTIVE
  This trial compared the efficacy and tolerability of a single-use EBP combination package (EBP Pak) with those of its matching vehicle control (VC Pak) and the original, reconstituted formulation packaged in a jar (EBP Jar). The matching VC for the original formulation (VC Jar) was used to achieve study blinding.
  
  
  METHODS
  In this double-blind, parallel-group, multicenter study, patients were randomly assigned to the 4 treatment arms. The primary efficacy evaluations were lesion reductions from baseline and treatment success (as defined by a Physician's Global Acne Severity score of 0 [clear] or 0.5 [sparse comedones with few or no inflammatory lesions]). Secondary evaluations were Physician's Global Acne Severity scores, facial-oiliness scores, and end-point patient evaluations of global improvement and treatment acceptability. Tolerability was based on the incidence and severity of adverse events.
  
  
  RESULTS
  Three hundred twenty-seven patients (age range, 12-46 years) were randomly assigned to the 4 treatment groups (EBP Pak, 124; VC Pak, 42; EBP Jar. 121; VC Jar, 40). Mean percent reductions in total acne lesions, inflammatory acne lesions, and come-dones from baseline were significantly greater with EBP Pak than with VC Pak (P < or = 0.001 for the intent-to-treat patient population after 8 weeks). Statistical significance for all lesion parameters was demonstrated at week 2 (P < 0.05) and maintained throughout the study. At 8 weeks, a significantly greater proportion of patients demonstrated treatment success with the EBP Pak compared with VC Pak (28% vs 2%, respectively; P < 0.001). The EBP Pak was comparable to the EBP Jar in terms of reduction in acne lesions, Physician's Global Acne Severity scores, and end-of-treatment patient evaluations of global improvement. No serious drug-related adverse events were reported.
  
  
  CONCLUSIONS
  Results of this 8-week trial demonstrate that the single-use combination package of EBP is well tolerated, effective, and comparable to the original formulation for the treatment of acne vulgaris in this selected patient population.
authors.affiliation: Pennsylvania State University College of Medicine, Hershey, USA.
authors.forename: Diane
authors.initials: D
authors.lastname: Thiboutot
authors.forename: Michael
authors.initials: M
authors.lastname: Jarratt
authors.forename: Phoebe
authors.initials: P
authors.lastname: Rich
authors.forename: Toivo
authors.initials: T
authors.lastname: Rist
authors.forename: David
authors.initials: D
authors.lastname: Rodriguez
authors.forename: Sharon
authors.initials: S
authors.lastname: Levy
mesh_terms: D000152:Acne Vulgaris / Q000188:drug therapy*; D000293:Adolescent; D000328:Adult; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001585:Benzoyl Peroxide / Q000008:administration & dosage / Q000627:therapeutic use*; D002626:Chemistry, Pharmaceutical; D002648:Child; D004311:Double-Blind Method; D004338:Drug Combinations; D004917:Erythromycin / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D004338:Drug Combinations; D004917:Erythromycin; D001585:Benzoyl Peroxide