Clinical Trials Logo
  1. Home
  2. Warts
  3. NCT04253912
  4. Details
NCT04253912 Clinical Trial

Topical 2% Povidone-Iodine Gel in Verruca Vulgaris

Warts Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04253912
Other study ID # VBP-245-WART2A
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date February 12, 2020
Est. completion date April 2021

Study information
Verified date March 2021
Source Veloce BioPharma LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 90
Est. completion date April 2021
Est. primary completion date January 5, 2021
Accepts healthy volunteers No
Gender All
Age group 8 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• VBP-245
2% Povidone-Iodine Gel
• Placebo Gel (no Povidone-Iodine)
Placebo Gel (no Povidone-Iodine)

Locations
Country Name City State
United States Veloce BioPharma Clinical Trial Site Arlington Virginia
United States Veloce BioPharma Clinical Trial Site Fort Mill South Carolina
United States Veloce BioPharma Clinical Trial Site Hunt Valley Maryland
United States Veloce BioPharma Clinical Trial Site Lynchburg Virginia
United States Veloce BioPharma Clinical Trial Site Plymouth Meeting Pennsylvania
United States Veloce BioPharma Clinical Trial Site Sugarloaf Pennsylvania
United States Veloce BioPharma Clinical Trial Site Upper Saint Clair Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Veloce BioPharma LLC

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Decrease in wart diameter (mm) 12 weeks
Secondary Resolution of wart Wart diameter = 0 mm 12 weeks
Secondary Application Site Reaction Adverse Events 12 weeks
See also
  Status Clinical Trial Phase
Completed NCT01757392 - Candin Safety & Efficacy Study for the Treatment of Warts Phase 2
Completed NCT00973856 - Evaluation of the Effectiveness of an Alcohol Based Hand Gel for the Reduction of Warts on the Hands N/A
Completed NCT02902822 - Tele-dermatology of Skin Cancer in a Cohort of Local Health Authority Employees in the Province of Bergamo N/A
Withdrawn NCT00546611 - The Purpose of This Study is to Determine Whether Topical Application of PEP005 is Safe for the Treatment of Common Wart(s) Phase 1
Completed NCT00117871 - Study With a Topical Gel to Treat Common Warts in Adults Phase 2
Completed NCT04278573 - Intralesional Vitamin D Injection for Treatment of Common Warts Phase 2
Completed NCT02231879 - Plerixafor Versus G-CSF in the Treatment of People With WHIM Syndrome Phase 2/Phase 3
Completed NCT06309420 - Clinical Trial to Evaluate Efficacy and Safety of a Cryogenic Medical Device for Treatment of Common and Plantar Warts N/A
Not yet recruiting NCT05616078 - Laser Versus Cryotherapy for the Treatment of Recalcitrant Warts N/A
Not yet recruiting NCT05617950 - Salicylic Acid Versus Cryotherapy for the Treatment of HPV1-induced Plantar Warts N/A
Recruiting NCT01712295 - 17% Salicylate Versus 17% Salicylate-Ethyl Pyruvate for Plantar Foot Warts Phase 4
Active, not recruiting NCT00254280 - Treatment of Recalcitrant Hand and Foot Warts With Intense Pulsed Light - a Randomized Controlled Trial N/A
Completed NCT04781244 - Cost-effectiveness of EndWarts® FREEZE - an Alternative Home Cryotherapy Device for Wart Treatment N/A
Completed NCT01101750 - Does the HPV Vaccine Cause the Same Response in Adolescent Kidney and Liver Transplant Patients as in Healthy Controls? Phase 4
Completed NCT03487549 - Cantharidin and Occlusion in Verruca Epithelium Phase 2
Recruiting NCT05625633 - Human Papillomavirus (HPV) Vaccination vs. Placebo for the Treatment of Refractory Cutaneous Warts Phase 2/Phase 3
Completed NCT02393417 - Safety and Efficacy of Varying Regimens of CANDIN for Treatment of Common Warts (Verruca Vulgaris) Phase 2
Completed NCT01808443 - Efficacy of Laser Versus Cryotherapy in the Treatment of Warts N/A
Completed NCT00116675 - Four Week Safety and Efficacy Study With a Topical Gel to Treat Common Warts in Pediatric Subjects Phase 2
Completed NCT00116662 - An up to Twelve Week Safety and Efficacy Study With a Topical Gel to Treat Common Warts in Pediatric Subjects Phase 2