title: 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.
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.
authors.affiliation: Department of Dermatology, Tokyo Women's Medical University, Tokyo, Japan.
authors.forename: Makoto
authors.initials: M
authors.lastname: Kawashima
authors.affiliation: Department of Dermatology, Graduate School of Medicine and Faculty of Medicine, The University of Tokyo, Tokyo, Japan.
authors.forename: Shinichi
authors.initials: S
authors.lastname: Sato
authors.affiliation: Department of Dermatology, Wakayama Medical University, Wakayama, Japan.
authors.forename: Fukumi
authors.initials: F
authors.lastname: Furukawa
authors.affiliation: Departments of Integrative Medical Science for Allergic Disease, Fujita Health University School of Medicine, Aichi, Japan.
authors.forename: Kayoko
authors.initials: K
authors.lastname: Matsunaga
authors.affiliation: Department of Applied Cell and Regenerative Medicine, Fujita Health University School of Medicine, Aichi, Japan.
authors.forename: Hirohiko
authors.initials: H
authors.lastname: Akamatsu
authors.affiliation: Dermatology, NTT Medical Center Tokyo, Tokyo, Japan.
authors.forename: Atsuyuki
authors.initials: A
authors.lastname: Igarashi
authors.affiliation: Department of Dermatology, Tokyo Women's Medical University, Tokyo, Japan.
authors.forename: Yuichiro
authors.initials: Y
authors.lastname: Tsunemi
authors.affiliation: Department of Dermatology, Toranomon Hospital, Tokyo, Japan.
authors.forename: Nobukazu
authors.initials: N
authors.lastname: Hayashi
authors.affiliation: Department of Dermatology, Wakayama Medical University, Wakayama, Japan.
authors.forename: Yuki
authors.initials: Y
authors.lastname: Yamamoto
authors.affiliation: Medical Writing Group, Data Science Department, Maruho Co. Ltd, Kyoto, Japan.
authors.forename: Toshitaka
authors.initials: T
authors.lastname: Nagare
authors.affiliation: Medical Writing Group, Data Science Department, Maruho Co. Ltd, Kyoto, Japan.
authors.forename: Tsuneo
authors.initials: T
authors.lastname: Katsuramaki
mesh_terms: D000152:Acne Vulgaris / Q000188:drug therapy*; D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D001585:Benzoyl Peroxide / Q000494:pharmacology / Q000627:therapeutic use*; D003879:Dermatologic Agents / Q000494:pharmacology / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004890:Erythema / Q000139:chemically induced / Q000453:epidemiology; D005260:Female; D005782:Gels / Q000627:therapeutic use; D006801:Humans; D015994:Incidence; D007564:Japan; D008297:Male; D008875:Middle Aged; D010919:Placebos; D012867:Skin / Q000187:drug effects*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D003879:Dermatologic Agents; D005782:Gels; D010919:Placebos; D001585:Benzoyl Peroxide
keywords: acne vulgaris; benzoyl peroxide; comparative study; placebo-controlled; randomized