Warts
Conditions
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.
Interventions
DRUGVBP-245
2% Povidone-Iodine Gel
DRUGPlacebo Gel (no Povidone-Iodine)
Placebo Gel (no Povidone-Iodine)
Sponsors
Veloce BioPharma LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decrease in wart diameter (mm) | 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resolution of wart | 12 weeks | Wart diameter = 0 mm |
| Application Site Reaction Adverse Events | 12 weeks | — |
Countries
United States
Outcome results
None listed