Common Warts (Verruca Vulgaris)
Conditions
Keywords
Common wart, Intralesional injection, Candida albicans, Immunotherapy
Brief summary
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: * does treatment with Candin result in better clearance of warts than placebo * how many injections are required to result in wart clearance Participants will * have one wart selected for injection every two weeks until clearance * return 12 weeks after wart clearance for assessment of durability of response
Detailed description
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.
Interventions
DRUGCandin, Intradermal Solution
Injection at the base of the selected wart
DRUGPlacebo
Injection at the base of the selected wart
Sponsors
Nielsen BioSciences, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Unblinded site staff will prepare syringes of study drug for administration by blinded study staff
Intervention model description
Randomized, Double-Blind, Placebo-Controlled Study
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 3, but not more than 20 common warts (Verruca vulgaris) * Willing to agree to use adequate contraception methods during the study
Exclusion criteria
* Systemic or localized diseases, conditions, or medications that could interfere with the assessment of safety or efficacy or that compromise immune function * Candin delayed type hypersensitivity reaction test wheal sized \< 5 mm or \> 25 mm at the Baseline Visit * History of keloid formation * Prior treatment of common warts with liquid nitrogen, carbon dioxide, electrodesiccation, laser, surgery, salicylic acid, etc., that, in the Investigator's opinion, does not exhibit complete healing from the treatment * Treatment with immunotherapy (e.g., diphenylcyclopropenone \[DPCP\], dinitrochlorobenzene \[DNCB\], or other), imiquimod, 5-fluorouracil, bleomycin, or podophyllin within 12 weeks of the Baseline Visit or during the study * Prior treatment with Candida albicans within 12 weeks of the Baseline Visit or during the study * Systemic treatment with an immunosuppressive drug during the study or in the 6 months or 5 half lives prior to the Baseline Visit or during the study (e.g., azathioprine, 6 mercaptopurine, methotrexate, infliximab, adalimumab, etanercept, systemic steroids \[topical or inhaled steroids are acceptable\]). * Use of cantharidin or an investigational agent or device within the 30 days prior to the Baseline Visit or during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with complete resolution of the treatment wart | Twelve weeks after last injection | Absence of visual or measurable wart maintained through the entire Observational Period for injected wart |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to wart clearance | Up to 27 weeks | Time from first injection to achieving clinical clearance of the treatment wart. Clinical clearance is no evidence of the wart by visual inspection. |
| Number of participants with clinical clearance of at least 50% of all measured warts | Up to 27 weeks | The injected wart and up to five other warts will be measured. Clinical clearance is no evidence of the wart by visual inspection. |
| Number of participants with clinical clearance of all measured warts | Up to 27 weeks | The injected wart and up to five other warts will be measured. Clinical clearance is no evidence of the wart by visual inspection. |
| Time to clinical clearance of all measured warts | Up to 27 weeks | The injected wart and up to five other warts will be measured. Clinical clearance is no evidence of the wart by visual inspection. |
Countries
United States
Outcome results
None listed