A randomized, parallel, vehicle-controlled comparison of two erythromycin/benzoyl peroxide preparations for acne vulgaris

Diane Thiboutot, Michael Jarratt, Phoebe Rich, Toivo Rist, David Rodriguez, Sharon Levy

Research output: Contribution to journalArticle

11 Citations (Scopus)

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 comedones from baseline were significantly greater with EBP Pak than with VC Pak (P ≤ 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.

Original languageEnglish (US)
Pages (from-to)773-785
Number of pages13
JournalClinical Therapeutics
Volume24
Issue number5
DOIs
StatePublished - Jan 1 2002
Externally publishedYes

Fingerprint

Acne Vulgaris
Therapeutics
Physicians
erythromycin drug combination benzoyl peroxide
Refrigeration
Drug-Related Side Effects and Adverse Reactions
Pharmacists
Double-Blind Method
Population
Multicenter Studies
Incidence

Keywords

  • Acne vulgaris
  • Benzoyl peroxide
  • Combination treatment
  • Erythromycin

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

Cite this

A randomized, parallel, vehicle-controlled comparison of two erythromycin/benzoyl peroxide preparations for acne vulgaris. / Thiboutot, Diane; Jarratt, Michael; Rich, Phoebe; Rist, Toivo; Rodriguez, David; Levy, Sharon.

In: Clinical Therapeutics, Vol. 24, No. 5, 01.01.2002, p. 773-785.

Research output: Contribution to journalArticle

Thiboutot, Diane ; Jarratt, Michael ; Rich, Phoebe ; Rist, Toivo ; Rodriguez, David ; Levy, Sharon. / A randomized, parallel, vehicle-controlled comparison of two erythromycin/benzoyl peroxide preparations for acne vulgaris. In: Clinical Therapeutics. 2002 ; Vol. 24, No. 5. pp. 773-785.
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T1 - A randomized, parallel, vehicle-controlled comparison of two erythromycin/benzoyl peroxide preparations for acne vulgaris

AU - Thiboutot, Diane

AU - Jarratt, Michael

AU - Rich, Phoebe

AU - Rist, Toivo

AU - Rodriguez, David

AU - Levy, Sharon

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N2 - 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 comedones from baseline were significantly greater with EBP Pak than with VC Pak (P ≤ 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.

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