Candin Safety & Efficacy Study for the Treatment of Warts

Phase 2

Completed

• Conditions: Warts; Human Papilloma Virus
• Interventions: Biological: Candida albicans Skin Test Antigen

• Registration Number: NCT01757392
• Lead Sponsor: Nielsen BioSciences, Inc.

Brief 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.

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-12-21
• Study First Submitted QC: 2012-12-27
• Study First Posted: 2012-12-28
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Disposition First Submitted: 2018-07-20
• Disposition First Submitted QC: 2019-03-06
• Disposition First Posted: 2019-03-11
• Results First Submitted: 2020-12-15
• Results First Submitted QC: 2020-12-15
• Status Verified: 2021-01
• Results First Posted: 2021-01-11
• Last Update Submitted: 2021-01-13
• Last Update Posted: 2021-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Candin® 0.3 mL	Candida albicans Skin Test Antigen	Monthly intralesional injections of Candin® 0.3 ml until lesion resolves or up to 6 injections.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Johnson Dermatology; 🇺🇸 Fort Smith, Arkansas, United States