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Candin for the Treatment of Common Warts

Primary Purpose

Common Warts (Verruca Vulgaris)

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Candin, Intradermal Solution
Placebo
Sponsored by
Nielsen BioSciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Common Warts (Verruca Vulgaris) focused on measuring Common wart, Intralesional injection, Candida albicans, Immunotherapy

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Candin treatment

    Placebo

    Arm Description

    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

    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

    Outcomes

    Primary Outcome Measures

    Number of participants with complete resolution of the treatment wart
    Absence of visual or measurable wart maintained through the entire Observational Period for injected wart

    Secondary Outcome Measures

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

    Full Information

    First Posted
    May 2, 2023
    Last Updated
    July 14, 2023
    Sponsor
    Nielsen BioSciences, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05889845
    Brief Title
    Candin for the Treatment of Common Warts
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    June 2025 (Anticipated)
    Study Completion Date
    June 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Nielsen BioSciences, Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Common Warts (Verruca Vulgaris)
    Keywords
    Common wart, Intralesional injection, Candida albicans, Immunotherapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized, Double-Blind, Placebo-Controlled Study
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    Unblinded site staff will prepare syringes of study drug for administration by blinded study staff
    Allocation
    Randomized
    Enrollment
    330 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Candin treatment
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    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
    Intervention Type
    Drug
    Intervention Name(s)
    Candin, Intradermal Solution
    Intervention Description
    Injection at the base of the selected wart
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Injection at the base of the selected wart
    Primary Outcome Measure Information:
    Title
    Number of participants with complete resolution of the treatment wart
    Description
    Absence of visual or measurable wart maintained through the entire Observational Period for injected wart
    Time Frame
    Twelve weeks after last injection
    Secondary Outcome Measure Information:
    Title
    Time to wart clearance
    Description
    Time from first injection to achieving clinical clearance of the treatment wart. Clinical clearance is no evidence of the wart by visual inspection.
    Time Frame
    Up to 27 weeks
    Title
    Number of participants with clinical clearance of at least 50% of all measured warts
    Description
    The injected wart and up to five other warts will be measured. Clinical clearance is no evidence of the wart by visual inspection.
    Time Frame
    Up to 27 weeks
    Title
    Number of participants with clinical clearance of all measured warts
    Description
    The injected wart and up to five other warts will be measured. Clinical clearance is no evidence of the wart by visual inspection.
    Time Frame
    Up to 27 weeks
    Title
    Time to clinical clearance of all measured warts
    Description
    The injected wart and up to five other warts will be measured. Clinical clearance is no evidence of the wart by visual inspection.
    Time Frame
    Up to 27 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nielsen Central Contact
    Phone
    858 571-2726
    Email
    medinfo@nielsenbio.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Candin for the Treatment of Common Warts

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