贝达霉素凝胶 10.3%对日本软疣患者的安全性和耐受性研究

JAAD International Pub Date : 2024-10-05 DOI:10.1016/j.jdin.2024.09.002

Makoto Kawashima MD, PhD , Yoshiyuki Kaneko BS , Manami Sawasaki BS , Kyohei Masubuchi BS , Hiroyuki Yasukawa BS , Saki Okada BS , Carolyn Enloe MPH , Carri Geer PhD , Martina Cartwright PhD , Tomoko Maeda-Chubachi MD, PhD , Takeshi Tani BS

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引用次数: 0

摘要

背景传染性软疣（MC）是一种传染性病毒性皮肤感染。方法SKN15B01 (JRCT2031230123)是一项2期、多中心、单组、开放标签研究，研究对象为年龄≥2岁、基线MC病变3-70个的日本患者。仅患有眼周 MC 和/或免疫抑制的患者被排除在外。SB206 12%每天一次涂抹于病变部位，持续12周。安全性终点包括不良事件和局部皮肤反应。探索性疗效终点包括皮损完全清除的患者比例和皮损计数与基线相比的百分比变化。结果20 名患者（12 名男性，8 名女性）的平均（范围）年龄为 5.2（3-13）岁，平均（范围）基线皮损计数为 22.5（8-44）。第12周时的完全清除率和基线变化率分别为60%和-89.2%。最常见的治疗相关不良反应是涂抹部位红斑（25%，5 例）、疼痛（25%，5 例）、尿道炎（25%，5 例）和皮炎（20%，4 例），严重程度均为轻度/中度。

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The safety and tolerability of berdazimer gel 10.3% in Japanese patients with molluscum contagiosum

Background

Molluscum contagiosum (MC) is a contagious viral skin infection. Berdazimer gel, 10.3% (SB206 12%) is approved in the United States as the first topical, at-home MC prescription medication.

Objective

To assess safety and tolerability of SB206 12% in Japanese patients with MC.

Methods

SKN15B01 (JRCT2031230123) was a phase 2, multicenter, single-group, open-label study in Japanese patients ≥2 years old with 3-70 baseline MC lesions. Patients with only periocular MC and/or immunosuppression were excluded. SB206 12% was applied once daily to lesions for 12 weeks. Safety endpoints included adverse events and local skin reactions. Exploratory efficacy endpoints included percentage of patients with complete lesion clearance and lesion count percent change from baseline.

Results

Twenty patients (12 males, 8 females) with mean (range) age of 5.2 (3-13) years and mean (range) baseline lesion counts of 22.5 (8-44). Complete clearance and percent change from baseline at week 12 were 60% and −89.2%, respectively. The most common treatment-related adverse events were application site-erythema (25%, n = 5), -pain (25%, n = 5), -pruritis (25%, n = 5), and -dermatitis (20%, n = 4), all mild/moderate in severity.