Study With Candida Antigen for Treatment of Warts

December 29, 2010 updated by: University of Arkansas

A Phase 1 Study to Evaluate the Immunologic Mechanisms Underlying Wart Resolution After Intralesional Immunotherapy With Candida Antigen

The purpose of this study is to look at how people respond to the treatment of warts through use of the Candida antigen to get an immune response to rid the body of human papillomavirus (HPV). The immune system is the part of the body that fights infections like HPV which causes warts. This research study will examine the response of your wart when injected with a portion of a common yeast (candida) which is the study drug. Your immune system response will also be looked at by doing a test called an ELISPOT assay. This test is done on blood samples. The results of this test may help us to determine how the Candida antigen affects your wart.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The use of recall antigens for treating warts is not yet Food and Drug Administration (FDA) approved. The primary goal of this work was to assess the safety of Candin as an investigational new drug (IND) for the treatment of warts. In addition, clinical resolution of treated and untreated warts was evaluated and immunologic responses were examined using an ex vivo interferon-γ enzyme-linked immunospot (IFN-γ ELISPOT) assay in order to elucidate the immunologic mechanisms behind the successful regression of warts in patients undergoing Candin injection immunotherapy.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

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
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences

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

16 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects must be ages 18-50.
  • Female subjects of child-bearing potential must have a negative urine pregnancy test before each treatment.
  • Female subjects of child-bearing potential agree to use a reliable form of birth- control as the risks associated with candida antigens during pregnancy are not known.
  • Subjects must have two or more cutaneous, non-genital, non-facial warts.
  • Subjects must be able to provide written, informed consent.
  • Subjects must be willing to comply with the requirements of the protocol.

  • Subjects vital signs must be within the following parameters at time of enrollment:

    • Blood Pressure - <150/95 mmHg
    • Temperature - <100.4° F
    • Pulse Rate - 50 to 100 beats/minute
    • Respiratory Rate - <24 breaths/minute

Exclusion Criteria:

  • Subjects who have a history of disease or treatment that has caused the subject to be immunosuppressed to include, but not limited to, cancer, HIV, or organ transplantation. Immunosuppression will be determined only by medical history.
  • Subjects who are pregnant, lactating, or attempting to become pregnant, as the risks associated with candida antigens during pregnancy are not known.
  • Subjects who have only genital or facial warts.
  • Subjects who are unable to return for follow-up visits or comply with the protocol.
  • Subjects who have a known allergy to Thimerosol or the candida antigen.
  • Subjects who have a history of asthma as determined by a medical history or treatment for an asthmatic episode.
  • Subjects who have any type of diabetes.
  • Subjects who are currently using non-selective Beta Blockers.
  • Subjects who are currently using H2 antagonists (e.g., cimetidine). There will be a 24 hour washout period for any use of H2 antagonists prior to beginning treatment in the study.
  • Subjects who have a history of keloid formation.
  • Subjects who have a history of alcohol or illicit drug abuse, as determined only by medical history.
  • Subjects who have had previous treatment with candida antigens for their warts.
  • Subjects who are currently using any other treatments for their warts. This includes prescription or over-the-counter medications. Subjects must have a wash¬out period of 30 days for any previous treatments prior to beginning the study.
  • Subjects with a blood pressure >150/95, temperature >100.4° F, pulse rate <50 or >100 beats per minute, and respiratory rate >24 at time of enrollment.

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

  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Candida Antigen
Drug: Candida Antigen
Intralesional injection of 0.3ml candida antigen into largest wart at baseline visit and then every 3 weeks +/- 3 days for a maximum of 10 treatments.
Other Names:
  • Candin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Clinical Resolution of Injected Wart
Time Frame: Initial visit to completion of protocol, which is up to 30 weeks
When the participant completed the protocol, clinical resolution of the injected wart was determined by the overall percentage of resolution from the initial visit. Participants were classified as 'complete responders' if they had complete resolution of the injected wart, 'partial responders' if the injected wart regressed between 25% and 99%, and 'non-responders' if they had not achieved at least 25% regression of the injected wart.
Initial visit to completion of protocol, which is up to 30 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Clinical Resolution of 1st Anatomically Distant, Non-injected Wart
Time Frame: Initial visit to completion of protocol, which is up to 30 weeks
When the participant completed the protocol, clinical resolution of 1st anatomically distant, non-injected wart was determined by the overall percentage of resolution from the initial visit.
Initial visit to completion of protocol, which is up to 30 weeks
Number of Participants With Clinical Resolution of 2nd Anatomically Distant, Non-injected Wart
Time Frame: Initial visit to completion of protocol, which is up to 30 weeks
When the participant completed the protocol, clinical resolution of 2nd anatomically distant, non-injected wart was determined by the overall percentage of resolution from the initial visit.
Initial visit to completion of protocol, which is up to 30 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Immune Response to Human Papillomavirus Type 57 (HPV-57) L1-peptide
Time Frame: Initial visit to completion of protocol, which is up to 30 weeks
Immunologic responses from peripheral blood mononuclear cells collected prior to vaccination and post-vaccination were measured by ex vivo interferon-γ enzyme-linked immunospot (IFN-γ ELISPOT) assay to human papillomavirus type 57 L1-peptide.
Initial visit to completion of protocol, which is up to 30 weeks

Collaborators and Investigators

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

Sponsor

University of Arkansas

Collaborators

Allermed Laboratories, Inc.

Investigators

  • Principal Investigator: Mayumi Nakagawa, MD, PhD, University of Arkansas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2007

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

December 6, 2007

First Submitted That Met QC Criteria

December 6, 2007

First Posted (Estimate)

December 7, 2007

Study Record Updates

Last Update Posted (Estimate)

January 25, 2011

Last Update Submitted That Met QC Criteria

December 29, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 46487

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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