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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
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.
Initial visit to completion of protocol, which is up to 30 weeks
Mayumi Nakagawa, MD, PhD
University of Arkansas
United States: Food and Drug Administration
|University of Arkansas for Medical Sciences||Little Rock, Arkansas 72205|