A phase 3, multicenter, randomized, double‐blind, vehicle‐controlled, parallel‐group study of 5% sofpironium bromide (BBI‐4000) gel in Japanese patients with primary axillary hyperhidrosis. Issue 3 (7th January 2021)

• Record Type: Journal Article
• Authors: Yokozeki, Hiroo; Fujimoto, Tomoko; Abe, Yoichiro; Igarashi, Masaru; Ishikoh, Akiko; Omi, Tokuya; Kanda, Hiroki; Kitahara, Hiroto; Kinoshita, Miwako; Nakasu, Ichiro; Hattori, Naoko; Horiuchi, Yuki; Maruyama, Ryuji; Mizutani, Haruko; Murakami, Yoshiyuki; Watanabe, Chiharu; Kume, Akihiro; Hanafusa, Takaaki; Hamaguchi, Masamitsu; Yoshioka, Akira; Egami, Yuriko; Matsuo, Keizo; Matsuda, Tomoko; Akamatsu, Motoki; Yorozuya, Toshiyuki; Takayama, Shinichi
• Is Part Of: Journal of dermatology. Volume 48:Issue 3(2021)
• Page Start: 279
• Page End: 288
• Publication Date: 2021-01-07
• Subjects: BBI‐4000 -- Hyperhidrosis Disease Severity Score -- phase 3 study -- primary axillary hyperhidrosis -- sofpironium bromide gel; Dermatology -- Periodicals; Dermatology -- Japan -- Periodicals; Skin -- Diseases -- Periodicals; 616.5005
• DOI: 10.1111/1346-8138.15668
• Languages: English
• ISSNs: 0385-2407

Abstract

Abstract: A phase 3 study was conducted to verify the efficacy and safety of 5% sofpironium bromide (BBI‐4000) gel (hereinafter referred to as sofpironium) administrated for 6 weeks in Japanese patients with primary axillary hyperhidrosis. The primary efficacy end‐point was the proportion of patients who satisfied both criteria of a Hyperhidrosis Disease Severity Score (HDSS) of 1 or 2 at the end of 6‐week treatment and a 50% or more reduction in total gravimetric weight of sweat at the end of treatment relative to baseline. A total of 281 patients were randomized to receive 5% sofpironium (141 patients) or vehicle (140 patients), and all patients were included in the full analysis set (FAS). In the FAS, 70.1% of patients were female, and the median age was 35.0 years. The proportion of patients who achieved the primary efficacy end‐point was 53.9% in the sofpironium group and 36.4% in the vehicle group, with a statistically significant difference of 17.5% (95% confidence interval, 6.02–28.93) between these two groups ( P = 0.003). The incidence of adverse events was 44.0% in the sofpironium group and 30.7% in the vehicle group, and the incidence of adverse drug reactions was 16.3% in the sofpironium group and 5.0% in the vehicle group. Reported adverse events were generally mild or moderate in severity. In the sofpironium group, common events (incidence, ≥5%) were nasopharyngitis (14.2%) and dermatitis/erythema at the application site (8.5%/5.7%), with no serious adverse events reported. This study demonstrated the efficacy and safety of 5% sofpironium.