Warts, HPV
Conditions
Keywords
Warts, Candida, HPV, Injections, Intralesional, Immune System
Brief 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.
Detailed description
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.
Interventions
DRUGCandida 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.
Sponsors
Allermed Laboratories, Inc.
University of Arkansas
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinical Resolution of Injected Wart | Initial visit to completion of protocol, which is up to 30 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinical Resolution of 1st Anatomically Distant, Non-injected Wart | Initial visit to completion of protocol, which is up to 30 weeks | 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. |
| Number of Participants With Clinical Resolution of 2nd Anatomically Distant, Non-injected Wart | Initial visit to completion of protocol, which is up to 30 weeks | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Immune Response to Human Papillomavirus Type 57 (HPV-57) L1-peptide | Initial visit to completion of protocol, which is up to 30 weeks | Immunologic responses from peripheral blood mononuclear cells collected prior to vaccination and post-vaccination were measured by ex vivo interferon-γ enzyme-linked immunospot (IFN-γ ELISPOT) assay to human papillomavirus type 57 L1-peptide. |
Countries
United States
Participant flow
Recruitment details
Patients for this study were recruited during the period between February 2007 and May 2009 from the outpatient Dermatology Clinic.
Participants by arm
| Arm | Count |
|---|---|
| Candida Antigen All patients enrolled into the study were treated with 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. | 18 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Airfare expense | 2 |
| Overall Study | Car accident injury | 1 |
| Overall Study | Non-compliance | 2 |
| Overall Study | Study unrelated surgery | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Candida Antigen |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants |
| Age Continuous | 29.8 years STANDARD_DEVIATION 9.1 |
| Region of Enrollment United States | 18 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 15 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
Primary
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
Population: The participants were analyzed if they completed the protocol by achieving complete resolution of the treated wart, receiving the maximum of 10 treatments, or by having less than 25% resolution of the treated wart after 5 treatments.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Candida Antigen | Number of Participants With Clinical Resolution of Injected Wart | Complete responder | 9 Participants |
| Candida Antigen | Number of Participants With Clinical Resolution of Injected Wart | Partial responder | 1 Participants |
| Candida Antigen | Number of Participants With Clinical Resolution of Injected Wart | Non-responder | 1 Participants |
Secondary
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
Population: Participants with 1st anatomically distant, non-injected wart were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Candida Antigen | Number of Participants With Clinical Resolution of 1st Anatomically Distant, Non-injected Wart | Complete resolution of 1st non-injected wart | 6 Participants |
| Candida Antigen | Number of Participants With Clinical Resolution of 1st Anatomically Distant, Non-injected Wart | Partial resolution of 1st non-injected wart | 2 Participants |
Secondary
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
Population: The participants with 2nd anatomically distant, non-injected wart were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Candida Antigen | Number of Participants With Clinical Resolution of 2nd Anatomically Distant, Non-injected Wart | 6 Participants |
Other Pre-specified
Number of Participants With Immune Response to Human Papillomavirus Type 57 (HPV-57) L1-peptide
Immunologic responses from peripheral blood mononuclear cells collected prior to vaccination and post-vaccination were measured by ex vivo interferon-γ enzyme-linked immunospot (IFN-γ ELISPOT) assay to human papillomavirus type 57 L1-peptide.
Time frame: Initial visit to completion of protocol, which is up to 30 weeks
Population: The interferon-γ enzyme-linked immunospot assay was performed on available samples from participants who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Candida Antigen | Number of Participants With Immune Response to Human Papillomavirus Type 57 (HPV-57) L1-peptide | 6 Participants |