Topical 2% Povidone-Iodine Gel in Verruca Vulgaris

March 31, 2021 updated by: Veloce BioPharma LLC

A Phase 2, Double-Blind, Randomized, Parallel Group, Placebo-Controlled, Study to Evaluate Topical 2% Povidone-Iodine Gel (VBP-245) in Subjects With Verruca Vulgaris

This is a multi-center, randomized, double-blind, placebo-controlled phase 2 study in subjects 8 years of age and older who present with verruca vulgaris (common warts) and desire treatment. Subjects may have up to a total of 6 common warts located on their trunk or extremities that will be treated with study medication and followed throughout the study protocol therapy. All warts will be treated two times per day (BID) for12 weeks. Approximately 90 subjects will be enrolled in this study.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Hunt Valley, Maryland, United States, 21030
        • Veloce BioPharma Clinical Trial Site
    • Pennsylvania
      • Plymouth Meeting, Pennsylvania, United States, 19462
        • Veloce BioPharma Clinical Trial Site
      • Sugarloaf, Pennsylvania, United States, 18429
        • Veloce BioPharma Clinical Trial Site
      • Upper Saint Clair, Pennsylvania, United States, 15241
        • Veloce BioPharma Clinical Trial Site
    • South Carolina
      • Fort Mill, South Carolina, United States, 29708
        • Veloce BioPharma Clinical Trial Site
    • Virginia
      • Arlington, Virginia, United States, 22209
        • Veloce BioPharma Clinical Trial Site
      • Lynchburg, Virginia, United States, 24501
        • Veloce BioPharma Clinical Trial Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject is able to comprehend and is willing to sign an informed consent/assent for participation in this study.
  • Male or female ≥ 8 years old.
  • Subject has a clinical diagnosis of verruca vulgaris (common warts).
  • Subject has up to 6 warts located on the trunk or extremities

Exclusion Criteria:

  • Subject has clinically atypical warts on the trunk or extremities.
  • Subject is immunocompromised (e.g., due to chemotherapy, systemic steroids, genetic immunodeficiency, transplant status, etc.)
  • Subject has periungual, subungual, genital, anal, mosaic, plantar, flat, or filiform wart identified as a wart for study treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VBP-245
Topical 2% Povidone-Iodine Gel
Drug: VBP-245
2% Povidone-Iodine Gel
Placebo Comparator: Control
Placebo Gel (no Povidone-Iodine)
Drug: Placebo Gel (no Povidone-Iodine)
Placebo Gel (no Povidone-Iodine)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Decrease in wart diameter (mm)
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resolution of wart
Time Frame: 12 weeks
Wart diameter = 0 mm
12 weeks
Application Site Reaction Adverse Events
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Veloce BioPharma LLC

Investigators

  • Study Director: Samuel Barone, MD, Veloce BioPharma LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2020

Primary Completion (Actual)

January 5, 2021

Study Completion (Anticipated)

April 1, 2021

Study Registration Dates

First Submitted

January 31, 2020

First Submitted That Met QC Criteria

January 31, 2020

First Posted (Actual)

February 5, 2020

Study Record Updates

Last Update Posted (Actual)

April 1, 2021

Last Update Submitted That Met QC Criteria

March 31, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VBP-245-WART2A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Aggregate data will be shared with study investigators.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Warts

Clinical Trials on VBP-245

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Costa Rica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe