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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
330
Injection at the base of the selected wart
Injection at the base of the selected wart
Cahaba Dermatology
Birmingham, Alabama, United States
Arkansas Pediatric Clinic
Bryant, Arkansas, United States
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
Time frame: Twelve weeks after last injection
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.
Time frame: Up to 27 weeks
Number of participants with clinical clearance of at least 50% 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 27 weeks
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