Back to resultsCandin Safety & Efficacy Study for the Treatment of Warts
Primary Purpose
Warts, Human Papilloma Virus
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Candida albicans Skin Test Antigen
Sponsored by
About this trial
This is an interventional treatment trial for Warts focused on measuring Treatment, common wart lesions, (verruca vulgaris)
Eligibility Criteria
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
Sites / Locations
- Johnson Dermatology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Candin® 0.3 mL
Arm Description
Monthly intralesional injections of Candin® 0.3 ml until lesion resolves or up to 6 injections.
Outcomes
Primary Outcome Measures
Number of Participants With Complete Resolution of Primary Injected Wart
Secondary Outcome Measures
Number of Participants With Complete Resolution of the Primary Injected Wart by Number of Injection Visits
Full Information
NCT ID
NCT01757392
First Posted
December 21, 2012
Last Updated
January 13, 2021
Sponsor
Nielsen BioSciences, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01757392
Brief Title
Candin Safety & Efficacy Study for the Treatment of Warts
Official Title
Study of the Safety and Effectiveness of Candin for the Treatment of Common Warts
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nielsen BioSciences, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Warts, Human Papilloma Virus
Keywords
Treatment, common wart lesions, (verruca vulgaris)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Candin® 0.3 mL
Arm Type
Experimental
Arm Description
Monthly intralesional injections of Candin® 0.3 ml until lesion resolves or up to 6 injections.
Intervention Type
Biological
Intervention Name(s)
Candida albicans Skin Test Antigen
Other Intervention Name(s)
Candin®
Intervention Description
0.3 ml injected intralesionally monthly. Number of injections: until wart lesion is resolved or up to 6 injections.
Primary Outcome Measure Information:
Title
Number of Participants With Complete Resolution of Primary Injected Wart
Time Frame
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 Measure Information:
Title
Number of Participants With Complete Resolution of the Primary Injected Wart by Number of Injection Visits
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandy M Johnson, MD
Organizational Affiliation
Johnson Dermatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johnson Dermatology
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72916
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Candin Safety & Efficacy Study for the Treatment of Warts
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