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NCT01757392 Clinical Trial

Candin Safety & Efficacy Study for the Treatment of Warts

Human Papilloma Virus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01757392
Other study ID # Nieslen Protocol CFW-2c
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date September 2012
Est. completion date December 2014

Study information
Verified date January 2021
Source Nielsen BioSciences, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 39
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Candida albicans Skin Test Antigen
0.3 ml injected intralesionally monthly. Number of injections: until wart lesion is resolved or up to 6 injections.

Locations
Country Name City State
United States Johnson Dermatology Fort Smith Arkansas

Sponsors (1)
Lead Sponsor Collaborator
Nielsen BioSciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
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