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Candin Safety & Efficacy Study for the Treatment of Warts

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.
 
ClinicalTrials.gov Identifier: NCT01757392
Recruitment Status : Completed
First Posted : December 28, 2012
Last Update Posted : March 11, 2019
Sponsor:
Information provided by (Responsible Party):
Nielsen BioSciences, Inc.

Tracking Information
First Submitted Date  ICMJE December 21, 2012
First Posted Date  ICMJE December 28, 2012
Last Update Posted Date March 11, 2019
Study Start Date  ICMJE September 2012
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 18, 2013)
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
Original Primary Outcome Measures  ICMJE
 (submitted: December 27, 2012)
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 ]
Symptoms will be evaluated daily for 7 days following each monthly treatment for safety
Change History Complete list of historical versions of study NCT01757392 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2013)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: December 27, 2012)
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 ]
Presence or absence of wart lesions will be determined monthly
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Candin Safety & Efficacy Study for the Treatment of Warts
Official Title  ICMJE Study of the Safety and Effectiveness of Candin for the Treatment of Common Warts
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Warts
  • Human Papilloma Virus
Intervention  ICMJE 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®
Study Arms  ICMJE Experimental: Candin® 0.3 mL
Monthly intralesional injections of Candin® 0.3 ml until lesion resolves or up to 6 injections.
Intervention: Biological: Candida albicans Skin Test Antigen
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 18, 2013)
39
Original Estimated Enrollment  ICMJE
 (submitted: December 27, 2012)
66
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01757392
Other Study ID Numbers  ICMJE Nieslen Protocol CFW-2c
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nielsen BioSciences, Inc.
Study Sponsor  ICMJE Nielsen BioSciences, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sandy M Johnson, MD Johnson Dermatology
PRS Account Nielsen BioSciences, Inc.
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP