We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Candin Safety & Efficacy Study for the Treatment of Warts

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01757392
First Posted: December 28, 2012
Last Update Posted: October 5, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nielsen BioSciences, Inc.
  Purpose
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).

Condition Intervention Phase
Warts Human Papilloma Virus Biological: Candida albicans Skin Test Antigen Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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:


Further study details as provided by Nielsen BioSciences, Inc.:

Primary Outcome Measures:
  • Safety of Candin® (Candida albicans Skin Test Antigen) at 0.3 dose level at up to 6 monthly injections for treating common warts (Verruca vulgaris) [ Time Frame: Monthly evaluations for up to 5 months ]
    Symptoms will be evaluated daily for 7 days following each monthly treatment for safety


Secondary Outcome Measures:
  • Evaluation of the relative efficacy of the 0.3 mL dose levels of Candin® for up to 5 months [ Time Frame: Monthly evaluations for up to 5 months ]
    Presence or absence of wart lesions will be determined monthly


Enrollment: 39
Study Start Date: September 2012
Estimated Study Completion Date: December 2016
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Candin® 0.3 mL
Monthly intralesional injections of Candin® 0.3 ml until lesion resolves or up to 6 injections.
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.
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 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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
  • No preexisting inflammatory conditions at treatment site allowed
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01757392


Locations
United States, Arkansas
Johnson Dermatology
Fort Smith, Arkansas, United States, 72916
Sponsors and Collaborators
Nielsen BioSciences, Inc.
Investigators
Principal Investigator: Sandy M Johnson, MD Johnson Dermatology
  More Information

Responsible Party: Nielsen BioSciences, Inc.
ClinicalTrials.gov Identifier: NCT01757392     History of Changes
Other Study ID Numbers: Nieslen Protocol CFW-2c
First Submitted: December 21, 2012
First Posted: December 28, 2012
Last Update Posted: October 5, 2016
Last Verified: October 2016

Keywords provided by Nielsen BioSciences, 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