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Cantharidin Application in Molluscum Patients-1

NCT03377790 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 266

Last updated 2022-01-11

Study results available
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Summary

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.

Conditions

  • Molluscum Contagiosum

Interventions

COMBINATION_PRODUCT

VP-102 - Cantharidin, Topical Film Forming Solution

VP-102, a single-use drug device combination product containing (cantharidin) topical solution, 0.7% (w/v). Up to 4 applications of VP-102 will be administered to Molluscum lesions at 21-day intervals.

COMBINATION_PRODUCT

Placebo -Topical Film Forming Solution without VP-102

Placebo a single-use drug device combination product containing only the vehicle. Up to 4 applications of Placebo will be administered to Molluscum lesions at 21-day intervals.

Sponsors & Collaborators

  • Instat Consulting, Inc.

    collaborator OTHER

  • Paidion Research, Inc.

    collaborator INDUSTRY

  • Database Integrations, Inc.

    collaborator INDUSTRY

  • Verrica Pharmaceuticals Inc.

    lead INDUSTRY

Principal Investigators

  • Lawrence Eichenfield, MD · Rady Children's Hospital; San Diego, California

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-21
Primary Completion
2018-11-26
Completion
2018-11-26
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03377790 on ClinicalTrials.gov