Candin for the Treatment of Common Warts

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Common Warts (Verruca Vulgaris)

Intervention / Treatment
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* Drug: Candin, Intradermal Solution
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, Double-Blind, Placebo-Controlled Study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Candin treatment<br>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<br>* Injection at the base of the selected wart<br>|
| Placebo Comparator: Placebo<br>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<br>* Injection at the base of the selected wart<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Twelve weeks after last injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 27 weeks | 
| 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. | Up to 27 weeks | 
| 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. | Up to 27 weeks | 
| 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. | Up to 27 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Common wart, Intralesional injection, Candida albicans, Immunotherapy