A randomized, parallel, vehicle-controlled comparison of two erythromycin/benzoyl peroxide preparations for acne vulgaris.
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.
Thiboutot
Diane
D
Pennsylvania State University College of Medicine, Hershey, USA.
Jarratt
Michael
M
Rich
Phoebe
P
Rist
Toivo
T
Rodriguez
David
D
Levy
Sharon
S
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
D000900:Anti-Bacterial Agents; D004338:Drug Combinations; D004917:Erythromycin; D001585:Benzoyl Peroxide