Molluscum Contagiosum Clinical Trial
Official title:
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Pivotal Study to Evaluate the Safety and Efficacy of VP-102 Topical Film-Forming Solution [0.7% (w/v) Cantharidin] in Subjects (2 Years and Older) With Molluscum Contagiosum
This study is a Phase 3, randomized, double-blind, placebo-controlled, pivotal study to evaluate the safety and efficacy of VP-102 topical film-forming solution in subjects with Molluscum Contagiosum. VP-102 will be applied once every 21 days for up to 4 applications, to treatable molluscum contagiosum (molluscum) lesions on subjects 2 years and older. Efficacy will be assessed as the proportion of subjects achieving complete clearance of all treatable molluscum lesions (baseline and new) on the Day 84 visit.
This is a Phase 3, multi-center, randomized, double-blind, placebo (vehicle)-controlled, pivotal study that will be conducted in the United States to determine the efficacy and safety of VP-102 following treatment of molluscum lesions for up to 4 treatments, every 21 days, with VP-102/placebo in 250 subjects. Subjects will receive active VP-102 or placebo in a 3:2 ratio. Study drug (VP-102 or placebo) will be supplied in single-use applicators. The film-forming Study drug solution will be applied and left on the lesions for 24 hours before the subject and/or parents/guardian washes the lesions. Study drug may be removed prior to the 24-hour time point in the event treatment-emergent AEs are experienced. Molluscum lesions will be treated without occlusion in all anatomic areas including the face, trunk, back, arms, legs, hands, feet, anogenital region and buttocks. ;
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