NCT03186378

Evaluation of Systemic Exposure to VP-102 in Subjects With Molluscum Contagiosum.

A Phase 2, Open-Label Study to Evaluate the Safety, Efficacy and Systemic Exposure of VP-102 Topical Film Forming Solution [0.7% (w/v) Cantharidin] in Subjects (2 Years and Older) With Molluscum Contagiosum

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Verrica Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Accepted

Summary

The primary objective of the study is to determine the presence or absence of systemic cantharidin exposure from a single 24-hour dermal application of VP-102 topical film-forming solution \[0.7% (w/v) cantharidin\] (VP-102) when applied to molluscum contagiosum (molluscum) lesions on pediatric subjects 2 years old and older. Treatment will continue over the course of 3 additional 21 day intervals allowing for further evaluation of safety, efficacy and impact on quality of life.

Detailed description

This is a Phase 2, Open-Label Study to Evaluate the Safety, Efficacy and Systemic Exposure of VP-102 Topical Film Forming Solution \[0.7% (w/v) cantharidin\] in subjects 2 years and older with Molluscum Contagiosum. Up to 40 subjects will be enrolled in the study with the goal of 16 meeting criteria for, and completing all scheduled blood draws outlined in the exposure portion of the trial. Subjects that do not have enough molluscum lesions to participate in the exposure study but do meet all other criteria to participate in the study will be enrolled in the standard treatment group. No more than 16 subjects will complete exposure group activities; up to 16 subjects will be enrolled in the standard treatment group. The additional 8 subjects may be used for replacement patients. At least 3 patients in the exposure group will be from 2-5 years of age. All subjects will receive VP-102 containing 0.7% cantharidin to molluscum lesions every 21 days for a maximum of 4 sessions or until complete clearance. In the exposure group, blood samples for systemic exposure evaluation will be collected on Day 1, prior to the drug application, and 2 (± 30 minutes), 6 (± 1 hour) and 24 (±3 hours) hours post-application. A dermatological examination will be performed by a qualified investigator quantifying molluscum lesion counts at every study visit.

Conditions

• Molluscum Contagiosum

Interventions

Type	Name	Description
COMBINATION_PRODUCT	VP-102 with applicator	Subjects will receive treatment to their molluscum contagiosum with VP-102.

Timeline

• Start date: 2017-06-08
• Primary completion: 2018-06-25
• Completion: 2018-06-25
• First posted: 2017-06-14
• Last updated: 2021-08-11
• Results posted: 2021-08-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study