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Clinical Trials/NCT04253912
NCT04253912UnknownPhase 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

Veloce BioPharma LLC1 site in 1 country90 target enrollmentStarted: February 12, 2020Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Enrollment
90
Locations
1
Primary Endpoint
Decrease in wart diameter (mm)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
8 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts 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.

Arms & Interventions

VBP-245

Experimental

Topical 2% Povidone-Iodine Gel

Intervention: VBP-245 (Drug)

Control

Placebo Comparator

Placebo Gel (no Povidone-Iodine)

Intervention: Placebo Gel (no Povidone-Iodine) (Drug)

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)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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