Candin Safety & Efficacy Study for the Treatment of Warts

January 13, 2021 updated by: Nielsen BioSciences, Inc.

Study of the Safety and Effectiveness of Candin for the Treatment of Common Warts

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

39

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Fort Smith, Arkansas, United States, 72916
        • Johnson Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Candin®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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 Measures

Outcome Measure
Time Frame
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nielsen BioSciences, Inc.

Investigators

  • Principal Investigator: Sandy M Johnson, MD, Johnson Dermatology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

December 21, 2012

First Submitted That Met QC Criteria

December 27, 2012

First Posted (Estimate)

December 28, 2012

Study Record Updates

Last Update Posted (Actual)

February 4, 2021

Last Update Submitted That Met QC Criteria

January 13, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nieslen Protocol CFW-2c

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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