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NCT04253912 Clinical Trial

Topical 2% Povidone-Iodine Gel in Verruca Vulgaris

Warts Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04253912
Other study ID # VBP-245-WART2A
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date February 12, 2020
Est. completion date April 2021

Study information
Verified date March 2021
Source Veloce BioPharma LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 90
Est. completion date April 2021
Est. primary completion date January 5, 2021
Accepts healthy volunteers No
Gender All
Age group 8 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• VBP-245
2% Povidone-Iodine Gel
• Placebo Gel (no Povidone-Iodine)
Placebo Gel (no Povidone-Iodine)

Locations
Country Name City State
United States Veloce BioPharma Clinical Trial Site Arlington Virginia
United States Veloce BioPharma Clinical Trial Site Fort Mill South Carolina
United States Veloce BioPharma Clinical Trial Site Hunt Valley Maryland
United States Veloce BioPharma Clinical Trial Site Lynchburg Virginia
United States Veloce BioPharma Clinical Trial Site Plymouth Meeting Pennsylvania
United States Veloce BioPharma Clinical Trial Site Sugarloaf Pennsylvania
United States Veloce BioPharma Clinical Trial Site Upper Saint Clair Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Veloce BioPharma LLC

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Decrease in wart diameter (mm) 12 weeks
Secondary Resolution of wart Wart diameter = 0 mm 12 weeks
Secondary Application Site Reaction Adverse Events 12 weeks
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