Candin Safety & Efficacy Study for the Treatment of Warts
This study is currently recruiting participants.
Verified December 2012 by Allermed Laboratories, Inc.
Sponsor:
Allermed Laboratories, Inc.
Information provided by (Responsible Party):
Allermed Laboratories, Inc.
ClinicalTrials.gov Identifier:
NCT01757392
First received: December 21, 2012
Last updated: December 27, 2012
Last verified: December 2012
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Purpose
The primary objective of this study is to determine the safety of Candin® (Candida albicans Skin Test Antigen) at 0.3 and 0.5 ml dose levels at up to 6 monthly injections for treating common warts (Verruca vulgaris).
| Condition | Intervention | Phase |
|---|---|---|
|
Warts Human Papilloma Virus |
Biological: Candida albicans Skin Test Antigen |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Study of the Safety and Effectiveness of Candin for the Treatment of Common Warts |
Resource links provided by NLM:
MedlinePlus related topics:
Warts
Drug Information available for:
Candida albicans
U.S. FDA Resources
Further study details as provided by Allermed Laboratories, Inc.:
Primary Outcome Measures:
- Safety of Candin® (Candida albicans Skin Test Antigen) at 0.3 and 0.5 ml dose levels at up to 6 monthly injections for treating common warts (Verruca vulgaris) [ Time Frame: Monthly evaluations for up to 5 months ] [ Designated as safety issue: Yes ]Symptoms will be evaluated daily for 7 days following each monthly treatment for safety
Secondary Outcome Measures:
- Evaluation of the relative efficacy of the two dose levels of Candin® for up to 5 months [ Time Frame: Monthly evaluations for up to 5 months ] [ Designated as safety issue: No ]Presence or absence of wart lesions will be determined monthly
| Estimated Enrollment: | 66 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Candin® 0.3 mL
Monthly injections of Candin® 0.3 ml until lesion resolves up to 6 injections.
|
Biological: Candida albicans Skin Test Antigen
0.3 ml or 0.5 ml intralesionally monthly. Number of injections: until wart lesion is resolved up to 6 injections.
Other Name: Candin®
|
|
Experimental: Candin® 0.5 mL
Monthly injections of Candin® 0.5 ml until lesion resolves up to 6 injections
|
Biological: Candida albicans Skin Test Antigen
0.3 ml or 0.5 ml intralesionally monthly. Number of injections: until wart lesion is resolved up to 6 injections.
Other Name: Candin®
|
Detailed Description:
The primary objective of this study is to determine the safety of Candin® (Candida albicans Skin Test Antigen) at either 0.3 or 0.5 mL dose levels at up to 6 monthly injections (a maximal, cumulative dose of 1.9 or 3.1 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 and 0.5 mL dose levels 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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01757392
Contacts
| Contact: Marty C Johnson, MS | 828-759-7497 | mjohnson@greerlabs.com |
| Contact: Terrance Coyne, MD | 828-759-7495 | tcoynemd@greerlabs.com |
Locations
| United States, Arkansas | |
| Johnson Dermatology | Recruiting |
| Fort Smith, Arkansas, United States, 72916 | |
| Contact: Sandra M Johnson, MD 479-649-3376 drsandy@johnsondermatology.com | |
| Principal Investigator: Sandra M Johnson, MD | |
Sponsors and Collaborators
Allermed Laboratories, Inc.
Investigators
| Principal Investigator: | Sandy M Johnson, MD | Johnson Dermatology |
More Information
No publications provided
| Responsible Party: | Allermed Laboratories, Inc. |
| ClinicalTrials.gov Identifier: | NCT01757392 History of Changes |
| Other Study ID Numbers: | Allermed Protocol CFW-2c |
| Study First Received: | December 21, 2012 |
| Last Updated: | December 27, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Allermed Laboratories, Inc.:
|
Treatment common wart lesions (verruca vulgaris) |
Additional relevant MeSH terms:
|
Papilloma Warts Neoplasms, Squamous Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Papillomavirus Infections |
DNA Virus Infections Virus Diseases Skin Diseases, Viral Tumor Virus Infections Skin Diseases, Infectious Skin Diseases |
ClinicalTrials.gov processed this record on May 23, 2013