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The goal of this clinical trial is to compare outcome in healthy subjects 12 years of age and older with at least 3, but no more than 20, common warts (Verruca vulgaris) following treatment with Candin or placebo. The main questions it aims to answer are:
This study involves a comparison of an equal volume injection of Candin with an injection of placebo (unpreserved normal saline solution) in common warts. Subjects will be randomized 2:1 to receive Candin or placebo. During the Treatment Period, 1 dose (0.5 mL) of investigational product (IP) will be injected every 2 weeks into a single treatment wart until either clinical clearance of the treatment wart is achieved or a total of 10 injections have been administered.
Subjects achieving clinical clearance of the treatment wart will receive a final injection at the site of the cleared wart and then immediately enter the Observational Period for 12 weeks. Complete resolution is achieved when a subject demonstrates clinical clearance for 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Candin treatment | Experimental | Candida albicans Skin Test Antigen for Cellular Hypersensitivity will be administered as a 0.5 mL injection at the region of the interdigitated base of the treatment wart (epidermal/dermal junction) every 2 weeks for up to 10 injections |
|
| Placebo | Placebo Comparator | Matching placebo (sterile saline) will be administered as a 0.5 mL injection at the region of the interdigitated base of the treatment wart (epidermal/dermal junction) every 2 weeks for up to 10 injections |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Candin, Intradermal Solution | Drug | Injection at the base of the selected wart |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with complete resolution of the treatment wart | Absence of visual or measurable wart maintained through the entire Observational Period for injected wart | Twelve weeks after last injection |
| Measure | Description | Time Frame |
|---|---|---|
| Time to wart clearance | Time from first injection to achieving clinical clearance of the treatment wart. Clinical clearance is no evidence of the wart by visual inspection. | Up to 27 weeks |
| Number of participants with clinical clearance of at least 50% of all measured warts |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cahaba Dermatology | Birmingham | Alabama | 35244 | United States | ||
| Arkansas Pediatric Clinic |
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Randomized, Double-Blind, Placebo-Controlled Study
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Unblinded site staff will prepare syringes of study drug for administration by blinded study staff
| Placebo |
| Drug |
Injection at the base of the selected wart |
|
The injected wart and up to five other warts will be measured. Clinical clearance is no evidence of the wart by visual inspection. |
| Up to 27 weeks |
| Number of participants with clinical clearance of all measured warts | The injected wart and up to five other warts will be measured. Clinical clearance is no evidence of the wart by visual inspection. | Up to 27 weeks |
| Time to clinical clearance of all measured warts | The injected wart and up to five other warts will be measured. Clinical clearance is no evidence of the wart by visual inspection. | Up to 27 weeks |
| Bryant |
| Arkansas |
| 72022 |
| United States |
| Johnson Dermatology | Fort Smith | Arkansas | 72916 | United States |
| Dermatology Clinic of Arkansas | Hot Springs | Arkansas | 71913 | United States |
| Velocity Clinical La Mesa | La Mesa | California | 91942 | United States |
| Long Beach Research | Long Beach | California | 90805 | United States |
| Integrative Skin Research | Sacramento | California | 95815 | United States |
| Velocity Clinical Englewood | Englewood | Colorado | 80110 | United States |
| Kaminska Dermatology | Chicago | Illinois | 60657 | United States |
| Integrated Dermatology of Newton-Brighton | Brighton | Massachusetts | 02135 | United States |
| Hamzavi Dermatology | Fort Gratiot | Michigan | 48059 | United States |
| Schlessinger MD | Omaha | Nebraska | 68144 | United States |
| Advocare Berlin Medical Associates | Berlin | New Jersey | 08009 | United States |
| Bryn Mawr Health Center | Newtown Square | Pennsylvania | 19073 | United States |
| Velocity Clinical Spartanburg | Spartanburg | South Carolina | 29303 | United States |
| DermResearch | Austin | Texas | 78759 | United States |
| Austin Institute for Clinical Research | Pflugerville | Texas | 78660 | United States |
| Velocity Clinical Hampton | Hampton | Virginia | 23666 | United States |
| ID | Term |
|---|---|
| D014860 | Warts |
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D017193 | Skin Diseases, Viral |
| D014412 | Tumor Virus Infections |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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