Ignite Creation Date:
2025-12-24 @ 3:27 PM
Ignite Modification Date:
2026-03-04 @ 8:23 PM
Study NCT ID:
NCT01757392
Status:
COMPLETED
Last Update Posted:
2021-02-04
First Post:
2012-12-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Candin Safety & Efficacy Study for the Treatment of Warts
Sponsor:
Nielsen BioSciences, Inc.
Organization:
Study Overview
Official Title:
Study of the Safety and Effectiveness of Candin for the Treatment of Common Warts
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: