Candin Safety & Efficacy Study for the Treatment of Warts

Study Overview
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Brief Summary
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The primary objective of this study is to determine the safety of Candin® (Candida albicans Skin Test Antigen) at a 0.3 ml dose level at up to 6 monthly injections for treating common warts (Verruca vulgaris).

Detailed Description
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The primary objective of this study is to determine the safety of Candin® (Candida albicans Skin Test Antigen) at either 0.3 mL dose levels at up to 6 monthly injections (a maximal, cumulative dose of 1.9 mL, including the delayed-type hypersensitivity (DTH) test) for treating common warts (Verruca vulgaris). A secondary objective is to understand the relative effectiveness of the 0.3 dose level for treating common warts, both those that were injected and those that were not injected as well as other types of warts that were not injected to allow a determination of appropriate dose levels to use in a future dose-ranging efficacy trial.

Official Title
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Study of the Safety and Effectiveness of Candin for the Treatment of Common Warts

Conditions
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Warts, Human Papilloma Virus

Intervention / Treatment
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* Biological: Candida albicans Skin Test Antigen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must have at least 3 and not more than 10 common warts not located on the palms or digits Positive DTH response to Candin® required Exclusion Criteria: No previous medical treatment for warts other than OTC No immunocompromising medical conditions or medicines allowed No preexisting inflammatory conditions at treatment site allowed

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Candin® 0.3 mL<br>Monthly intralesional injections of Candin® 0.3 ml until lesion resolves or up to 6 injections. | Biological: Candida albicans Skin Test Antigen<br>* 0.3 ml injected intralesionally monthly. Number of injections: until wart lesion is resolved or up to 6 injections.<br>* Other names: Candin®;|

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 Primary Injected Wart |  | Monthly evaluations during injection visit for up to 5 months, the follow up visits at 1 and 4 months after last dose for a total of approximately 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Complete Resolution of the Primary Injected Wart by Number of Injection Visits |  | Monthly evaluations during injection visit for up to 5 months, the follow up visits at 1 and 4 months after last dose for a total of approximately 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment, common wart lesions, (verruca vulgaris)