Study With Candida Antigen for Treatment of Warts

This study has been completed.
Sponsor:
Collaborator:
Allermed Laboratories, Inc.
Information provided by:
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00569231
First received: December 6, 2007
Last updated: December 29, 2010
Last verified: December 2010
  Purpose

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.


Condition Intervention Phase
Warts
HPV
Drug: Candida Antigen
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Phase 1 Study to Evaluate the Immunologic Mechanisms Underlying Wart Resolution After Intralesional Immunotherapy With Candida Antigen

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • Number of Participants With Clinical Resolution of Injected Wart [ Time Frame: Initial visit to completion of protocol, which is up to 30 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 18
Study Start Date: February 2007
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Candin

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00569231

Locations
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Allermed Laboratories, Inc.
Investigators
Principal Investigator: Mayumi Nakagawa, MD, PhD University of Arkansas
  More Information

Publications:
Responsible Party: Mayumi Nakagawa, University of Arkansas for Medical Sciences
ClinicalTrials.gov Identifier: NCT00569231     History of Changes
Other Study ID Numbers: 46487
Study First Received: December 6, 2007
Results First Received: November 23, 2010
Last Updated: December 29, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Arkansas:
Warts
Candida
HPV
Injections, Intralesional
Immune System

Additional relevant MeSH terms:
Warts
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Tumor Virus Infections
Neoplasms
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on August 27, 2014