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Sponsors and Collaborators: |
University of Arkansas Allermed Laboratories, Inc. |
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Information provided by: | University of Arkansas |
ClinicalTrials.gov Identifier: | NCT00569231 |
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 by doing a test called an ELISPOT assay. This test is done with a blod sample and a sample of one of your warts. The results of this test may help us to determine how the candida antigen affects your wart.
Condition | Intervention | Phase |
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Warts HPV |
Drug: Candida Antigen |
Phase I |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase 1 Study to Evaluate the Immunologic Mechanisms Underlying Wart Resolution After Intralesional Immunotherapy With Candida Antigen |
Estimated Enrollment: | 50 |
Study Start Date: | February 2007 |
Estimated Study Completion Date: | February 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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One: Experimental |
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.
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Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects vital signs must be within the following parameters at time of enrollment:
Exclusion Criteria:
Contact: Joni Pharis, RN | 501- 603-1505 | PharisJoni@uams.edu |
United States, Arkansas | |
University of Arkansas for Medical Sciences | Recruiting |
Little Rock, Arkansas, United States, 72205 | |
Principal Investigator: Mayumi Nakagawa, MD, PhD |
Principal Investigator: | Mayumi Nakagawa, MD, PhD | University of Arkansas |
Responsible Party: | University of Arkansas for Medical Sciences ( L. D. Milne, PhD/Vice Chancellor for Research and Academic Affairs ) |
Study ID Numbers: | 46487 |
Study First Received: | December 6, 2007 |
Last Updated: | December 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00569231 |
Health Authority: | United States: Food and Drug Administration |
Warts Candida HPV Injections, Intralesional Immune System |
Virus Diseases Skin Diseases, Infectious Warts Skin Diseases |
DNA Virus Infections Papillomavirus Infections Torulopsis |
Skin Diseases, Viral Neoplasms Tumor Virus Infections |