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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started Feb 2020

Shorter than P25 for phase_2

Geographic Reach

1 country

7 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.1 years study duration

First Submitted

Initial submission to the registry

January 31, 2020

Completed

5 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed

7 days until next milestone

Study Start

First participant enrolled

February 12, 2020

Completed

11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2021

Completed

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed

Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

11 months

First QC Date

January 31, 2020

Last Update Submit

March 31, 2021

Conditions

Warts

Outcome Measures

Primary Outcomes (1)

Decrease in wart diameter (mm)
12 weeks

Secondary Outcomes (2)

Resolution of wart
12 weeks
Application Site Reaction Adverse Events
12 weeks

Study Arms (2)

VBP-245

EXPERIMENTAL

Topical 2% Povidone-Iodine Gel

Drug: VBP-245

Control

PLACEBO COMPARATOR

Placebo Gel (no Povidone-Iodine)

Drug: Placebo Gel (no Povidone-Iodine)

Interventions

VBP-245DRUG

2% Povidone-Iodine Gel

VBP-245

Placebo Gel (no Povidone-Iodine)DRUG

Placebo Gel (no Povidone-Iodine)

Control

Eligibility Criteria

Age8 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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.

Contact the study team to confirm eligibility.