泽苏米（贝达齐默）外用凝胶。

Zelsuvmi (Berdazimer) Topical Gel.

作者信息

Gupta Aditya K, Mann Avantika, Vincent Kimberly, Abramovits William

机构信息

Division of Dermatology, Department of Medicine, University of Toronto School of Medicine, Toronto, Ontario, Canada.

Mediprobe Research Inc., London, Ontario, Canada;

出版信息

Skinmed. 2024 Dec 31;22(6):460-462. eCollection 2024.

PMID:39748580

Abstract

Zelsuvmi (berdazimer) topical gel has been approved recently for the treatment of molluscum contagiosum (MC) in patients aged ≥1 year. In three phase 3, randomized, double-blind, vehicle-controlled trials of similar design, berdazimer was investigated for the treatment of MC. Berdazimer or vehicle was applied once daily on MC lesions until complete lesion clearance was observed or for up to 12 weeks. Berdazimer demonstrated higher efficacy in achieving the primary outcome at week 12 (Trial 1, berdazimer: 32.4% [144/444] and vehicle: 19.7% [88/447]; Trial 2, berdazimer: 30% [71/237] and vehicle: 20.3% [24/118]; and Trial 3, berdazimer: 26% [61/236] and vehicle: 22% [28/126]), compared to vehicle. Common adverse events were the mild to moderate reactions, including application site pain, dermatitis, exfoliation, erythema, pruritus, and lesions.

摘要

Zelsuvmi（伯达齐默）外用凝胶最近已被批准用于治疗1岁及以上患者的传染性软疣（MC）。在三项设计相似的3期随机双盲、赋形剂对照试验中，对伯达齐默治疗MC进行了研究。伯达齐默或赋形剂每天在MC皮损上涂抹一次，直到观察到皮损完全清除或长达12周。与赋形剂相比，伯达齐默在第12周实现主要结局方面显示出更高的疗效（试验1，伯达齐默：32.4%[144/444]，赋形剂：19.7%[88/447]；试验2，伯达齐默：30%[71/237]，赋形剂：20.3%[24/118]；试验3，伯达齐默：26%[61/236]，赋形剂：22%[28/126]）。常见不良事件为轻至中度反应，包括用药部位疼痛、皮炎、脱屑、红斑、瘙痒和皮损。