Back to resultsTopical 2% Povidone-Iodine Gel in Verruca Vulgaris
Primary Purpose
Warts
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
VBP-245
Placebo Gel (no Povidone-Iodine)
Sponsored by
About this trial
This is an interventional treatment trial for Warts
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.
Sites / Locations
- Veloce BioPharma Clinical Trial Site
- Veloce BioPharma Clinical Trial Site
- Veloce BioPharma Clinical Trial Site
- Veloce BioPharma Clinical Trial Site
- Veloce BioPharma Clinical Trial Site
- Veloce BioPharma Clinical Trial Site
- Veloce BioPharma Clinical Trial Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
VBP-245
Control
Arm Description
Topical 2% Povidone-Iodine Gel
Placebo Gel (no Povidone-Iodine)
Outcomes
Primary Outcome Measures
Decrease in wart diameter (mm)
Secondary Outcome Measures
Resolution of wart
Wart diameter = 0 mm
Application Site Reaction Adverse Events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04253912
Brief Title
Topical 2% Povidone-Iodine Gel in Verruca Vulgaris
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 12, 2020 (Actual)
Primary Completion Date
January 5, 2021 (Actual)
Study Completion Date
April 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Veloce BioPharma LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Warts
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VBP-245
Arm Type
Experimental
Arm Description
Topical 2% Povidone-Iodine Gel
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Placebo Gel (no Povidone-Iodine)
Intervention Type
Drug
Intervention Name(s)
VBP-245
Intervention Description
2% Povidone-Iodine Gel
Intervention Type
Drug
Intervention Name(s)
Placebo Gel (no Povidone-Iodine)
Intervention Description
Placebo Gel (no Povidone-Iodine)
Primary Outcome Measure Information:
Title
Decrease in wart diameter (mm)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Resolution of wart
Description
Wart diameter = 0 mm
Time Frame
12 weeks
Title
Application Site Reaction Adverse Events
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel Barone, MD
Organizational Affiliation
Veloce BioPharma LLC
Official's Role
Study Director
Facility Information:
Facility Name
Veloce BioPharma Clinical Trial Site
City
Hunt Valley
State/Province
Maryland
ZIP/Postal Code
21030
Country
United States
Facility Name
Veloce BioPharma Clinical Trial Site
City
Plymouth Meeting
State/Province
Pennsylvania
ZIP/Postal Code
19462
Country
United States
Facility Name
Veloce BioPharma Clinical Trial Site
City
Sugarloaf
State/Province
Pennsylvania
ZIP/Postal Code
18429
Country
United States
Facility Name
Veloce BioPharma Clinical Trial Site
City
Upper Saint Clair
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
Facility Name
Veloce BioPharma Clinical Trial Site
City
Fort Mill
State/Province
South Carolina
ZIP/Postal Code
29708
Country
United States
Facility Name
Veloce BioPharma Clinical Trial Site
City
Arlington
State/Province
Virginia
ZIP/Postal Code
22209
Country
United States
Facility Name
Veloce BioPharma Clinical Trial Site
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Aggregate data will be shared with study investigators.
Learn more about this trial
Topical 2% Povidone-Iodine Gel in Verruca Vulgaris
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