Candin Safety & Efficacy Study for the Treatment of Warts

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Nielsen BioSciences, Inc.
ClinicalTrials.gov Identifier:
NCT01757392
First received: December 21, 2012
Last updated: October 28, 2013
Last verified: October 2013
  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: 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:


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 ] [ 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 0.3 mL 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


Enrollment: 39
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 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

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
  • No preexisting inflammatory conditions at treatment site allowed
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Nielsen BioSciences, Inc.
ClinicalTrials.gov Identifier: NCT01757392     History of Changes
Other Study ID Numbers: Nieslen Protocol CFW-2c
Study First Received: December 21, 2012
Last Updated: October 28, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 20, 2014