Candin for the Treatment of Common Warts

March 15, 2024 updated by: Nielsen BioSciences, Inc.

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Candin for the Treatment of Common Warts (Verruca Vulgaris) in Adolescents and Adults

The goal of this clinical trial is to compare outcome in healthy subjects 12 years of age and older with at least 3, but no more than 20, common warts (Verruca vulgaris) following treatment with Candin or placebo. The main questions it aims to answer are:

  • does treatment with Candin result in better clearance of warts than placebo
  • how many injections are required to result in wart clearance Participants will
  • have one wart selected for injection every two weeks until clearance
  • return 12 weeks after wart clearance for assessment of durability of response

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study involves a comparison of an equal volume injection of Candin with an injection of placebo (unpreserved normal saline solution) in common warts. Subjects will be randomized 2:1 to receive Candin or placebo. During the Treatment Period, 1 dose (0.5 mL) of investigational product (IP) will be injected every 2 weeks into a single treatment wart until either clinical clearance of the treatment wart is achieved or a total of 10 injections have been administered.

Subjects achieving clinical clearance of the treatment wart will receive a final injection at the site of the cleared wart and then immediately enter the Observational Period for 12 weeks. Complete resolution is achieved when a subject demonstrates clinical clearance for 12 weeks.

Study Type

Interventional

Enrollment (Estimated)

330

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35244
        • Recruiting
        • Cahaba Dermatology
        • Contact:
    • Arkansas
      • Bryant, Arkansas, United States, 72022
      • Fort Smith, Arkansas, United States, 72916
      • Hot Springs, Arkansas, United States, 71913
    • California
      • La Mesa, California, United States, 91942
      • Long Beach, California, United States, 90805
      • Sacramento, California, United States, 95815
    • Colorado
      • Englewood, Colorado, United States, 80110
    • Illinois
      • Chicago, Illinois, United States, 60657
    • Massachusetts
      • Brighton, Massachusetts, United States, 02135
        • Recruiting
        • Integrated Dermatology of Newton-Brighton
        • Contact:
    • Michigan
      • Fort Gratiot, Michigan, United States, 48059
        • Recruiting
        • Hamzavi Dermatology
        • Contact:
    • Nebraska
      • Omaha, Nebraska, United States, 68144
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Recruiting
        • Advocare Berlin Medical Associates
        • Contact:
    • Pennsylvania
      • Newtown Square, Pennsylvania, United States, 19073
    • South Carolina
      • Spartanburg, South Carolina, United States, 29303
    • Texas
      • Austin, Texas, United States, 78759
        • Recruiting
        • DermResearch
        • Contact:
        • Contact:
          • Candice Nkwo
      • Pflugerville, Texas, United States, 78660
        • Recruiting
        • Austin Institute for Clinical Research
        • Contact:
    • Virginia
      • Hampton, Virginia, United States, 23666

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • At least 3, but not more than 20 common warts (Verruca vulgaris)
  • Willing to agree to use adequate contraception methods during the study

Exclusion Criteria:

  • Systemic or localized diseases, conditions, or medications that could interfere with the assessment of safety or efficacy or that compromise immune function
  • Candin delayed type hypersensitivity reaction test wheal sized < 5 mm or > 25 mm at the Baseline Visit
  • History of keloid formation
  • Prior treatment of common warts with liquid nitrogen, carbon dioxide, electrodesiccation, laser, surgery, salicylic acid, etc., that, in the Investigator's opinion, does not exhibit complete healing from the treatment
  • Treatment with immunotherapy (e.g., diphenylcyclopropenone [DPCP], dinitrochlorobenzene [DNCB], or other), imiquimod, 5-fluorouracil, bleomycin, or podophyllin within 12 weeks of the Baseline Visit or during the study
  • Prior treatment with Candida albicans within 12 weeks of the Baseline Visit or during the study
  • Systemic treatment with an immunosuppressive drug during the study or in the 6 months or 5 half lives prior to the Baseline Visit or during the study (e.g., azathioprine, 6 mercaptopurine, methotrexate, infliximab, adalimumab, etanercept, systemic steroids [topical or inhaled steroids are acceptable]).
  • Use of cantharidin or an investigational agent or device within the 30 days prior to the Baseline Visit or during the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Candin treatment
Candida albicans Skin Test Antigen for Cellular Hypersensitivity will be administered as a 0.5 mL injection at the region of the interdigitated base of the treatment wart (epidermal/dermal junction) every 2 weeks for up to 10 injections
Drug: Candin, Intradermal Solution
Injection at the base of the selected wart
Placebo Comparator: Placebo
Matching placebo (sterile saline) will be administered as a 0.5 mL injection at the region of the interdigitated base of the treatment wart (epidermal/dermal junction) every 2 weeks for up to 10 injections
Drug: Placebo
Injection at the base of the selected wart

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with complete resolution of the treatment wart
Time Frame: Twelve weeks after last injection
Absence of visual or measurable wart maintained through the entire Observational Period for injected wart
Twelve weeks after last injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to wart clearance
Time Frame: Up to 27 weeks
Time from first injection to achieving clinical clearance of the treatment wart. Clinical clearance is no evidence of the wart by visual inspection.
Up to 27 weeks
Number of participants with clinical clearance of at least 50% of all measured warts
Time Frame: Up to 27 weeks
The injected wart and up to five other warts will be measured. Clinical clearance is no evidence of the wart by visual inspection.
Up to 27 weeks
Number of participants with clinical clearance of all measured warts
Time Frame: Up to 27 weeks
The injected wart and up to five other warts will be measured. Clinical clearance is no evidence of the wart by visual inspection.
Up to 27 weeks
Time to clinical clearance of all measured warts
Time Frame: Up to 27 weeks
The injected wart and up to five other warts will be measured. Clinical clearance is no evidence of the wart by visual inspection.
Up to 27 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nielsen BioSciences, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

May 2, 2023

First Submitted That Met QC Criteria

June 2, 2023

First Posted (Actual)

June 5, 2023

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 15, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CFW-3A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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