A Placebo-Controlled Study Using VP-102 in the Treatment of External Genital Warts

Summary

This is a Phase 2, double-blind, placebo-controlled study to determine the dose regimen, safety, tolerability, and efficacy of VP-102 in subjects with External Genital Warts (EGW). This study is divided into two parts (Part A and Part B). Increasing durations of skin exposure to study drug (VP-102 or placebo) will be evaluated in three treatment groups prior to progressing to enrollment in Part B. Part A \& B will enroll a approximately 108 subjects completing 4 treatment applications every 21 days and continuing with follow-up assessments at Day 84, 112 and 147.

Conditions

• Condylomata Acuminata
• Papillomavirus Infections
• Skin Diseases, Viral
• Skin Diseases, Infectious
• Skin Diseases
• Sexually Transmitted Diseases, Viral
• Sexually Transmitted Diseases
• Warts

Interventions

COMBINATION_PRODUCT

VP-102 and applicator

In part A, VP-102 will be applied for either 2, 6 or 24 hours with each regimen compared to placebo. For part B, 2 of the regimens from part A will be chosen for Part B with each compared to Placebo. Only 4 arms are actually being studied.

COMBINATION_PRODUCT

Placebo

The placebo single-use applicator contains the same formulation as the VP-102 applicator but does not contain the active pharmaceutical ingredient cantharidin

Sponsors & Collaborators

• Instat Consulting, Inc.

  collaborator OTHER

• Paidion Research, Inc.

  collaborator INDUSTRY

• BioClinica, Inc.

  collaborator INDUSTRY

• Verrica Pharmaceuticals Inc.

  lead INDUSTRY

Principal Investigators

• Scott Guenthner, MD · The Indiana Clinical Trials Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-06-25

Primary Completion

2020-05-21

Completion

2020-07-08

FDA Drug

Yes

FDA Device

Yes

Countries

• United States

Study Locations