NCT04253912
Unknown
Phase 2
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
ConditionsWarts
Overview
- Phase
- Phase 2
- Intervention
- VBP-245
- Conditions
- Warts
- Sponsor
- Veloce BioPharma LLC
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Decrease in wart diameter (mm)
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
VBP-245
Topical 2% Povidone-Iodine Gel
Intervention: VBP-245
Control
Placebo Gel (no Povidone-Iodine)
Intervention: Placebo Gel (no Povidone-Iodine)
Outcomes
Primary Outcomes
Decrease in wart diameter (mm)
Time Frame: 12 weeks
Secondary Outcomes
- Resolution of wart(12 weeks)
- Application Site Reaction Adverse Events(12 weeks)
Study Sites (1)
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