Topical 2% Povidone-Iodine Gel in Verruca Vulgaris

Sponsor

Veloce BioPharma LLC (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04253912

Collaborator

(none)

Enrollment

Locations

Arms

13.6

Anticipated Duration (Months)

12.9

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Warts	Drug: VBP-245 Drug: Placebo Gel (no Povidone-Iodine)	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 12, 2020

Actual Primary Completion Date :

Jan 5, 2021

Anticipated Study Completion Date :

Apr 1, 2021

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

Decrease in wart diameter (mm) [12 weeks]

Secondary Outcome Measures

Resolution of wart [12 weeks]
Wart diameter = 0 mm
Application Site Reaction Adverse Events [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Veloce BioPharma Clinical Trial Site	Hunt Valley	Maryland	United States	21030
2	Veloce BioPharma Clinical Trial Site	Plymouth Meeting	Pennsylvania	United States	19462
3	Veloce BioPharma Clinical Trial Site	Sugarloaf	Pennsylvania	United States	18429
4	Veloce BioPharma Clinical Trial Site	Upper Saint Clair	Pennsylvania	United States	15241
5	Veloce BioPharma Clinical Trial Site	Fort Mill	South Carolina	United States	29708
6	Veloce BioPharma Clinical Trial Site	Arlington	Virginia	United States	22209
7	Veloce BioPharma Clinical Trial Site	Lynchburg	Virginia	United States	24501

Sponsors and Collaborators

Veloce BioPharma LLC

Investigators

Study Director: Samuel Barone, MD, Veloce BioPharma LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Veloce BioPharma LLC

ClinicalTrials.gov Identifier:

NCT04253912

Other Study ID Numbers:

VBP-245-WART2A

First Posted:

Feb 5, 2020

Last Update Posted:

Apr 1, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Warts

Povidone-Iodine

Povidone

Study Results

No Results Posted as of Apr 1, 2021