Topical 2% Povidone-Iodine Gel in Verruca Vulgaris

NCT ID: NCT04253912

Last Updated: 2021-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-12

Study Completion Date

2021-04-30

Brief Summary

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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

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Conditions

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Warts

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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VBP-245

Topical 2% Povidone-Iodine Gel

Group Type EXPERIMENTAL

VBP-245

Intervention Type DRUG

2% Povidone-Iodine Gel

Control

Placebo Gel (no Povidone-Iodine)

Group Type PLACEBO_COMPARATOR

Placebo Gel (no Povidone-Iodine)

Intervention Type DRUG

Placebo Gel (no Povidone-Iodine)

Interventions

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VBP-245

2% Povidone-Iodine Gel

Intervention Type DRUG

Placebo Gel (no Povidone-Iodine)

Placebo Gel (no Povidone-Iodine)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Veloce BioPharma LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Samuel Barone, MD

Role: STUDY_DIRECTOR

Veloce BioPharma LLC

Locations

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Veloce BioPharma Clinical Trial Site

Hunt Valley, Maryland, United States

Site Status

Veloce BioPharma Clinical Trial Site

Plymouth Meeting, Pennsylvania, United States

Site Status

Veloce BioPharma Clinical Trial Site

Sugarloaf, Pennsylvania, United States

Site Status

Veloce BioPharma Clinical Trial Site

Upper Saint Clair, Pennsylvania, United States

Site Status

Veloce BioPharma Clinical Trial Site

Fort Mill, South Carolina, United States

Site Status

Veloce BioPharma Clinical Trial Site

Arlington, Virginia, United States

Site Status

Veloce BioPharma Clinical Trial Site

Lynchburg, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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VBP-245-WART2A

Identifier Type: -

Identifier Source: org_study_id

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