Topical 2% Povidone-Iodine Gel in Verruca Vulgaris
- Registration Number
- NCT04253912
- Lead Sponsor
- Veloce BioPharma LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 90
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description VBP-245 VBP-245 Topical 2% Povidone-Iodine Gel Control Placebo Gel (no Povidone-Iodine) Placebo Gel (no Povidone-Iodine)
- Primary Outcome Measures
Name Time Method Decrease in wart diameter (mm) 12 weeks
- Secondary Outcome Measures
Name Time Method Resolution of wart 12 weeks Wart diameter = 0 mm
Application Site Reaction Adverse Events 12 weeks
Trial Locations
- Locations (1)
Veloce BioPharma Clinical Trial Site
🇺🇸Lynchburg, Virginia, United States