Candin Safety & Efficacy Study for the Treatment of Warts

Nielsen BioSciences

Status and phase: Completed; Phase 2

Conditions: Human Papilloma Virus; Warts

Treatments: Biological: Candida albicans Skin Test Antigen

Study type: Interventional

Funder types: Industry

Identifiers

NCT01757392

Nieslen Protocol CFW-2c

Details and patient eligibility

About

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).

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 1 patient group

Candin® 0.3 mL

Experimental group

Description:

Monthly intralesional injections of Candin® 0.3 ml until lesion resolves or up to 6 injections.

Treatment:

Biological: Candida albicans Skin Test Antigen