Human Papilloma Virus, Warts
Conditions
Keywords
Treatment, common wart lesions, (verruca vulgaris)
Brief summary
The primary objective of this study is to determine the safety of Candin® (Candida albicans Skin Test Antigen) at a 0.3 ml dose level at up to 6 monthly injections for treating common warts (Verruca vulgaris).
Detailed description
The primary objective of this study is to determine the safety of Candin® (Candida albicans Skin Test Antigen) at either 0.3 mL dose levels at up to 6 monthly injections (a maximal, cumulative dose of 1.9 mL, including the delayed-type hypersensitivity (DTH) test) for treating common warts (Verruca vulgaris). A secondary objective is to understand the relative effectiveness of the 0.3 dose level for treating common warts, both those that were injected and those that were not injected as well as other types of warts that were not injected to allow a determination of appropriate dose levels to use in a future dose-ranging efficacy trial.
Interventions
BIOLOGICALCandida albicans Skin Test Antigen
0.3 ml injected intralesionally monthly. Number of injections: until wart lesion is resolved or up to 6 injections.
Sponsors
Nielsen BioSciences, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Must have at least 3 and not more than 10 common warts not located on the palms or digits * Positive DTH response to Candin® required
Exclusion criteria
* No previous medical treatment for warts other than OTC * No immunocompromising medical conditions or medicines allowed * No preexisting inflammatory conditions at treatment site allowed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Complete Resolution of Primary Injected Wart | Monthly evaluations during injection visit for up to 5 months, the follow up visits at 1 and 4 months after last dose for a total of approximately 9 months |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With Complete Resolution of the Primary Injected Wart by Number of Injection Visits | Monthly evaluations during injection visit for up to 5 months, the follow up visits at 1 and 4 months after last dose for a total of approximately 9 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Candin® 0.3 mL Monthly intralesional injections of Candida albicans Skin Test Antigen 0.3 ml into single wart until lesion resolves or up to 6 injections. | 35 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Screen Fail | 3 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Candin® 0.3 mL |
|---|---|
| Age, Continuous | 39.9 years STANDARD_DEVIATION 11.76 |
| Body Mass Index (BMI) | 28.66 kg/m^2 STANDARD_DEVIATION 5.6 |
| Height | 173.52 cm STANDARD_DEVIATION 10.982 |
| Race/Ethnicity, Customized Caucasian | 34 Participants |
| Race/Ethnicity, Customized Hispanic | 1 Participants |
| Region of Enrollment United States | 35 participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 18 Participants |
| Weight | 87.32 Kg STANDARD_DEVIATION 22.508 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 35 |
| other Total, other adverse events | 34 / 35 |
| serious Total, serious adverse events | 1 / 35 |
Outcome results
Primary
Number of Participants With Complete Resolution of Primary Injected Wart
Time frame: Monthly evaluations during injection visit for up to 5 months, the follow up visits at 1 and 4 months after last dose for a total of approximately 9 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Candin® 0.3 mL | Number of Participants With Complete Resolution of Primary Injected Wart | 19 Participants |
Secondary
Number of Participants With Complete Resolution of the Primary Injected Wart by Number of Injection Visits
Time frame: Monthly evaluations during injection visit for up to 5 months, the follow up visits at 1 and 4 months after last dose for a total of approximately 9 months
Population: Subjects experiencing complete resolution of the primary injected wart
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Candin® 0.3 mL | Number of Participants With Complete Resolution of the Primary Injected Wart by Number of Injection Visits | One Injection visit | 5 Participants |
| Candin® 0.3 mL | Number of Participants With Complete Resolution of the Primary Injected Wart by Number of Injection Visits | Two Injection visits | 4 Participants |
| Candin® 0.3 mL | Number of Participants With Complete Resolution of the Primary Injected Wart by Number of Injection Visits | Three Injection visits | 3 Participants |
| Candin® 0.3 mL | Number of Participants With Complete Resolution of the Primary Injected Wart by Number of Injection Visits | Four Injection visits | 4 Participants |
| Candin® 0.3 mL | Number of Participants With Complete Resolution of the Primary Injected Wart by Number of Injection Visits | Five Injection visits | 1 Participants |
| Candin® 0.3 mL | Number of Participants With Complete Resolution of the Primary Injected Wart by Number of Injection Visits | Six Injection visits | 2 Participants |
Post Hoc
Number of Participants With Complete Resolution of All Qualified Warts by Injection Visits
Time frame: Monthly evaluations during injection visit for up to 5 months, the follow up visits at 1 and 4 months after last dose for a total of approximately 9 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Candin® 0.3 mL | Number of Participants With Complete Resolution of All Qualified Warts by Injection Visits | One injection visit | 0 Participants |
| Candin® 0.3 mL | Number of Participants With Complete Resolution of All Qualified Warts by Injection Visits | Two injection visits | 0 Participants |
| Candin® 0.3 mL | Number of Participants With Complete Resolution of All Qualified Warts by Injection Visits | Three injection visits | 2 Participants |
| Candin® 0.3 mL | Number of Participants With Complete Resolution of All Qualified Warts by Injection Visits | Four injection visits | 4 Participants |
| Candin® 0.3 mL | Number of Participants With Complete Resolution of All Qualified Warts by Injection Visits | Five injection visits | 3 Participants |
| Candin® 0.3 mL | Number of Participants With Complete Resolution of All Qualified Warts by Injection Visits | Six injection visits | 3 Participants |
Post Hoc
Number of Participants With Complete Resolution of the First Non-injected Wart by Injection Visits
Time frame: Monthly evaluations during injection visit for up to 5 months, the follow up visits at 1 and 4 months after last dose for a total of approximately 9 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Candin® 0.3 mL | Number of Participants With Complete Resolution of the First Non-injected Wart by Injection Visits | Four Injection visits | 1 Participants |
| Candin® 0.3 mL | Number of Participants With Complete Resolution of the First Non-injected Wart by Injection Visits | One injection visit | 5 Participants |
| Candin® 0.3 mL | Number of Participants With Complete Resolution of the First Non-injected Wart by Injection Visits | Two injection visits | 2 Participants |
| Candin® 0.3 mL | Number of Participants With Complete Resolution of the First Non-injected Wart by Injection Visits | Three Injection visits | 5 Participants |
| Candin® 0.3 mL | Number of Participants With Complete Resolution of the First Non-injected Wart by Injection Visits | Five Injection visits | 0 Participants |
| Candin® 0.3 mL | Number of Participants With Complete Resolution of the First Non-injected Wart by Injection Visits | Six Injection visits | 5 Participants |
Post Hoc
Recurrence of Resolved Primary Wart at Follow up 2 Visit
Number of participants with recurrence of primary wart seen at the final follow up visit
Time frame: 4 months after last injection
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Candin® 0.3 mL | Recurrence of Resolved Primary Wart at Follow up 2 Visit | 4 Participants |