Candin Safety & Efficacy Study for the Treatment of Warts
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease, Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 3/13/2019 |
| Start Date: | September 2012 |
| End Date: | December 2014 |
Study of the Safety and Effectiveness of Candin for the Treatment of Common Warts
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).
Skin Test Antigen) at a 0.3 ml dose level at up to 6 monthly injections for treating common
warts (Verruca vulgaris).
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.
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.
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
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