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Brief Title: Candin for the Treatment of Common Warts
Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Candin for the Treatment of Common Warts (Verruca Vulgaris) in Adolescents and Adults
Study ID: NCT05889845
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.
Minimum Age: 12 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Cahaba Dermatology, Birmingham, Alabama, United States
Arkansas Pediatric Clinic, Bryant, Arkansas, United States
Johnson Dermatology, Fort Smith, Arkansas, United States
Dermatology Clinic of Arkansas, Hot Springs, Arkansas, United States
Velocity Clinical La Mesa, La Mesa, California, United States
Long Beach Research, Long Beach, California, United States
Integrative Skin Research, Sacramento, California, United States
Velocity Clinical Englewood, Englewood, Colorado, United States
Kaminska Dermatology, Chicago, Illinois, United States
Integrated Dermatology of Newton-Brighton, Brighton, Massachusetts, United States
Hamzavi Dermatology, Fort Gratiot, Michigan, United States
Schlessinger MD, Omaha, Nebraska, United States
Advocare Berlin Medical Associates, Berlin, New Jersey, United States
Bryn Mawr Health Center, Newtown Square, Pennsylvania, United States
Velocity Clinical Spartanburg, Spartanburg, South Carolina, United States
DermResearch, Austin, Texas, United States
Austin Institute for Clinical Research, Pflugerville, Texas, United States
Velocity Clinical Hampton, Hampton, Virginia, United States