ZelsuvmiTM (Berdazimer) Topical Gel.

Skinmed Pub Date : 2024-12-31 eCollection Date: 2024-01-01
Aditya K Gupta, Avantika Mann, Kimberly Vincent, William Abramovits
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Abstract

ZelsuvmiTM (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.

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ZelsuvmiTM (berdazimer)外用凝胶最近被批准用于治疗年龄≥1岁的传染性软疣(MC)患者。在三个设计相似的3期随机、双盲、载体对照试验中,研究了berdazimer对MC的治疗作用。berdazimer或载体每天一次应用于MC病变,直到观察到病变完全清除或长达12周。在第12周,Berdazimer在实现主要结局方面表现出更高的疗效(试验1,Berdazimer: 32.4%[144/444],对照组:19.7% [88/447];试验2,剂:30%[71/237],剂:20.3% [24/118];试验3,berdazimer: 26% [61/236], vehicle: 22%[28/126])。常见的不良反应为轻度至中度反应,包括应用部位疼痛、皮炎、脱落、红斑、瘙痒和病变。
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