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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Candin® 0.3 mL | Experimental | Monthly intralesional injections of Candin® 0.3 ml until lesion resolves or up to 6 injections. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Candida albicans Skin Test Antigen | Biological | 0.3 ml injected intralesionally monthly. Number of injections: until wart lesion is resolved or up to 6 injections. |
|
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sandy M Johnson, MD | Johnson Dermatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johnson Dermatology | Fort Smith | Arkansas | 72916 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Candin® 0.3 mL | Monthly intralesional injections of Candida albicans Skin Test Antigen 0.3 ml into single wart until lesions resolve or up to 6 injections. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
ITT population/ Safety Population
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Complete Resolution of Primary Injected Wart | Posted | Count of Participants | Participants | 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 |
|
|
All Post Dose visits over approximately 9 months, including treatment phase (5 months) and follow up period (4 months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Candin® 0.3 mL | Monthly intralesional injections of Candida albicans Skin Test Antigen 0.3 ml until lesion resolves or up to 6 injections. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholecystitis | Hepatobiliary disorders | MedDRA V17.0 | Non-systematic Assessment | cholecystitis followed by cholecystectomy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site erythema | General disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Burney | Nielsen Biosciences, Inc | 858-571-2726 | david@nielsenbio.com |
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| ID | Term |
|---|---|
| D014860 | Warts |
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | Kg |
|
| Height | Mean | Standard Deviation | cm |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
|
| Secondary | Number of Participants With Complete Resolution of the Primary Injected Wart by Number of Injection Visits | Subjects experiencing complete resolution of the primary injected wart | Posted | Count of Participants | Participants | 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 |
|
|
|
| Post-Hoc | Number of Participants With Complete Resolution of the First Non-injected Wart by Injection Visits | Posted | Count of Participants | Participants | 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 |
|
|
|
| Post-Hoc | Number of Participants With Complete Resolution of All Qualified Warts by Injection Visits | Posted | Count of Participants | Participants | 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 |
|
|
|
| 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 | Posted | Count of Participants | Participants | 4 months after last injection |
|
|
|
| 0 |
| 35 |
| 1 |
| 35 |
| 34 |
| 35 |
|
| Injection site Pain | General disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Injection site exfoliation | General disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Injection site vesicles | General disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Alanine aminotranferase increased | Investigations | MedDRA (17.0) | Non-systematic Assessment |
|
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| D017193 |
| Skin Diseases, Viral |
| D014412 | Tumor Virus Infections |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| Four Injection visits |
|
| Five Injection visits |
|
| Six Injection visits |
|
| Four Injection visits |
|
| Five Injection visits |
|
| Six Injection visits |
|
| Four injection visits |
|
| Five injection visits |
|
| Six injection visits |
|