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


Phase 1
18 Years
50 Years
Not Enrolling
Both
Warts, HPV

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Number of Participants With Clinical Resolution of Injected Wart

Outcome Description:

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.

Outcome Time Frame:

Initial visit to completion of protocol, which is up to 30 weeks

Safety Issue:

No

Principal Investigator

Mayumi Nakagawa, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Arkansas

Authority:

United States: Food and Drug Administration

Study ID:

46487

NCT ID:

NCT00569231

Start Date:

February 2007

Completion Date:

January 2010

Related Keywords:

  • Warts
  • HPV
  • Warts
  • Candida
  • HPV
  • Injections, Intralesional
  • Immune System
  • Warts

Name

Location

University of Arkansas for Medical Sciences Little Rock, Arkansas  72205