Candin for the Treatment of Common Warts

Last updated: February 4, 2025
Sponsor: Nielsen BioSciences, Inc.
Overall Status: Active - Not Recruiting

Phase

3

Condition

Warts

Treatment

Candin, Intradermal Solution

Placebo

Clinical Study ID

NCT05889845
CFW-3A
  • Ages > 12
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Systemic or localized diseases, conditions, or medications that could interfere withthe assessment of safety or efficacy or that compromise immune function

  • Candin delayed type hypersensitivity reaction test wheal sized < 5 mm or > 25 mm atthe Baseline Visit

  • History of keloid formation

  • Prior treatment of common warts with liquid nitrogen, carbon dioxide,electrodesiccation, laser, surgery, salicylic acid, etc., that, in theInvestigator'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, orpodophyllin within 12 weeks of the Baseline Visit or during the study

  • Prior treatment with Candida albicans within 12 weeks of the Baseline Visit orduring the study

  • Systemic treatment with an immunosuppressive drug during the study or in the 6months 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 tothe Baseline Visit or during the study

Study Design

Total Participants: 330
Treatment Group(s): 2
Primary Treatment: Candin, Intradermal Solution
Phase: 3
Study Start date:
March 05, 2024
Estimated Completion Date:
June 30, 2025

Study 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.

Connect with a study center

  • Cahaba Dermatology

    Birmingham, Alabama 35244
    United States

    Site Not Available

  • Arkansas Pediatric Clinic

    Bryant, Arkansas 72022
    United States

    Site Not Available

  • Johnson Dermatology

    Fort Smith, Arkansas 72916
    United States

    Site Not Available

  • Johnson Dermatology

    Ft. Smith, Arkansas 72916
    United States

    Site Not Available

  • Dermatology Clinic of Arkansas

    Hot Springs, Arkansas 71913
    United States

    Site Not Available

  • Velocity Clinical La Mesa

    La Mesa, California 91942
    United States

    Site Not Available

  • Long Beach Research

    Long Beach, California 90805
    United States

    Site Not Available

  • Integrative Skin Research

    Sacramento, California 95815
    United States

    Site Not Available

  • Velocity Clinical Englewood

    Englewood, Colorado 80110
    United States

    Site Not Available

  • Kaminska Dermatology

    Chicago, Illinois 60657
    United States

    Site Not Available

  • Integrated Dermatology of Newton-Brighton

    Brighton, Massachusetts 02135
    United States

    Site Not Available

  • Hamzavi Dermatology

    Fort Gratiot, Michigan 48059
    United States

    Site Not Available

  • Schlessinger MD

    Omaha, Nebraska 68144
    United States

    Site Not Available

  • Advocare Berlin Medical Associates

    Berlin, New Jersey 08009
    United States

    Site Not Available

  • Bryn Mawr Health Center

    Newtown Square, Pennsylvania 19073
    United States

    Site Not Available

  • Velocity Clinical Spartanburg

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • DermResearch

    Austin, Texas 78759
    United States

    Site Not Available

  • Austin Institute for Clinical Research

    Pflugerville, Texas 78660
    United States

    Site Not Available

  • Velocity Clinical Hampton

    Hampton, Virginia 23666
    United States

    Site Not Available

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