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Topical 2% Povidone-Iodine Gel in Verruca Vulgaris

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04253912
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
Veloce BioPharma LLC

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.

Condition or disease Intervention/treatment Phase
Warts Drug: VBP-245 Drug: Placebo Gel (no Povidone-Iodine) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : February 12, 2020
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Warts

Arm Intervention/treatment
Experimental: VBP-245
Topical 2% Povidone-Iodine Gel
Drug: VBP-245
2% Povidone-Iodine Gel

Placebo Comparator: Control
Placebo Gel (no Povidone-Iodine)
Drug: Placebo Gel (no Povidone-Iodine)
Placebo Gel (no Povidone-Iodine)




Primary Outcome Measures :
  1. Decrease in wart diameter (mm) [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Resolution of wart [ Time Frame: 12 weeks ]
    Wart diameter = 0 mm

  2. Application Site Reaction Adverse Events [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   8 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04253912


Contacts
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Contact: Samuel Barone, MD 2023908590 sbarone@velocebiopharma.com

Locations
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United States, Maryland
Veloce BioPharma Clinical Trial Site Recruiting
Hunt Valley, Maryland, United States, 21030
Contact: Study Director         
United States, Pennsylvania
Veloce BioPharma Clinical Trial Site Recruiting
Plymouth Meeting, Pennsylvania, United States, 19462
Contact: Study Director         
Veloce BioPharma Clinical Trial Site Recruiting
Sugarloaf, Pennsylvania, United States, 18429
Contact: Study Director         
Veloce BioPharma Clinical Trial Site Recruiting
Upper Saint Clair, Pennsylvania, United States, 15241
Contact: Study Director         
United States, South Carolina
Veloce BioPharma Clinical Trial Site Recruiting
Fort Mill, South Carolina, United States, 29708
United States, Virginia
Veloce BioPharma Clinical Trial Site Recruiting
Arlington, Virginia, United States, 22209
Contact: Study Director         
Veloce BioPharma Clinical Trial Site Recruiting
Lynchburg, Virginia, United States, 24501
Contact: Study Director         
Sponsors and Collaborators
Veloce BioPharma LLC
Investigators
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Study Director: Samuel Barone, MD Veloce BioPharma LLC
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Responsible Party: Veloce BioPharma LLC
ClinicalTrials.gov Identifier: NCT04253912    
Other Study ID Numbers: VBP-245-WART2A
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Aggregate data will be shared with study investigators.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Warts
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases
Povidone-Iodine
Povidone
Plasma Substitutes
Blood Substitutes
Anti-Infective Agents, Local
Anti-Infective Agents