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.
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
Allocation
NON_RANDOMIZED
Masking
NONE
Enrollment
18
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.
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Number of Participants With Clinical Resolution of Injected Wart
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.
Time frame: Initial visit to completion of protocol, which is up to 30 weeks
Number of Participants With Clinical Resolution of 1st Anatomically Distant, Non-injected Wart
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.
Time frame: 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
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.
Time frame: Initial visit to completion of protocol, which is up to 30 weeks
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