Phase 1
N=18
Study With Candida Antigen for Treatment of Warts
Warts · HPV
Bottom Line
View on ClinicalTrials.gov: NCT00569231 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Jan 2011
Primary outcome: Primary: Number of Participants With Clinical Resolution of Injected Wart — 9; 1; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Candida Antigen (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Arkansas
- Primary completion
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Clinical Resolution of Injected Wart |
9; 1; 1 | — |
| SECONDARY Number of Participants With Clinical Resolution of 1st Anatomically Distant, Non-injected Wart |
6; 2 | — |
| SECONDARY Number of Participants With Clinical Resolution of 2nd Anatomically Distant, Non-injected Wart |
6 | — |
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, temperature >100.4° F, pulse rate 100 beats per minute, and respiratory rate >24 at time of enrollment.
Data sourced from ClinicalTrials.gov (NCT00569231). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.