NCT01757392

Candin Safety & Efficacy Study for the Treatment of Warts

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Nielsen BioSciences, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Warts
• Human Papilloma Virus

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-09-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2012-12-28
• Last updated: 2021-02-04
• Results posted: 2021-01-11

Locations

1 site across 1 country: United States