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J Dermatol. 2017 Jul;44(7):774-782. doi: 10.1111/1346-8138.13798. Epub 2017 Mar 11.

Twelve-week, multicenter, placebo-controlled, randomized, double-blind, parallel-group, comparative phase II/III study of benzoyl peroxide gel in patients with acne vulgaris: A secondary publication.

Author information

1
Department of Dermatology, Tokyo Women's Medical University, Tokyo, Japan.
2
Department of Dermatology, Graduate School of Medicine and Faculty of Medicine, The University of Tokyo, Tokyo, Japan.
3
Department of Dermatology, Wakayama Medical University, Wakayama, Japan.
4
Departments of Integrative Medical Science for Allergic Disease, Fujita Health University School of Medicine, Aichi, Japan.
5
Department of Applied Cell and Regenerative Medicine, Fujita Health University School of Medicine, Aichi, Japan.
6
Dermatology, NTT Medical Center Tokyo, Tokyo, Japan.
7
Department of Dermatology, Toranomon Hospital, Tokyo, Japan.
8
Medical Writing Group, Data Science Department, Maruho Co. Ltd, Kyoto, Japan.

Abstract

A placebo-controlled, randomized, double-blind, parallel-group, comparative, multicenter study was conducted to investigate the efficacy and safety of benzoyl peroxide (BPO) gel, administrated once daily for 12 weeks to Japanese patients with acne vulgaris. Efficacy was evaluated by counting all inflammatory and non-inflammatory lesions. Safety was evaluated based on adverse events, local skin tolerability scores and laboratory test values. All 609 subjects were randomly assigned to receive the study products (2.5% and 5% BPO and placebo), and 607 subjects were included in the full analysis set, 544 in the per protocol set and 609 in the safety analyses. The median rates of reduction from baseline to the last evaluation of the inflammatory lesion counts, the primary end-point, in the 2.5% and 5% BPO groups were 72.7% and 75.0%, respectively, and were significantly higher than that in the placebo group (41.7%). No deaths or other serious adverse events were observed. The incidences of adverse events in the 2.5% and 5% BPO groups were 56.4% and 58.8%, respectively; a higher incidence than in the placebo group, but there was no obvious difference between the 2.5% and 5% BPO groups. All adverse events were mild or moderate in severity. Most adverse events did not lead to study product discontinuation. The results suggested that both 2.5% and 5% BPO are useful for the treatment of acne vulgaris.

KEYWORDS:

acne vulgaris; benzoyl peroxide; comparative study; placebo-controlled; randomized

PMID:
28295516
PMCID:
PMC5516201
DOI:
10.1111/1346-8138.13798
[Indexed for MEDLINE]
Free PMC Article

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