Study With Candida Antigen for Treatment of Warts
Condition: Warts; HPV
MeSH terms: Warts
Intervention: Candida Antigen
Intervention description: 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.
Phase: Phase 1
Study type: Interventional
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Warts; Candida; HPV; Injections, Intralesional; Immune System

Summary:

      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.
    

Eligibility 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.