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Brief Title: Safety and Efficacy of Varying Regimens of CANDIN for Treatment of Common Warts (Verruca Vulgaris)
Official Title: A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Varying Regimens of CANDIN for Treatment of Common Warts (Verruca Vulgaris)
Study ID: NCT02393417
Brief Summary: This is a placebo-controlled, double-blind (subject, Investigator, and site staff with the exception of unblinded dedicated staff to handle study medication), phase 2a study with 3 dose cohorts, randomized (concealed) to CANDIN or placebo (3:1). Main study will be up to 20 weeks (10 doses administered every other week) or until a subject has complete resolution of all injectable common warts. Subjects who cannot tolerate dosing every 2 weeks due to a local tolerance issue may be injected at 3-week intervals for up to 10 doses, increasing the length of the study to 29 weeks. Subjects will be followed for 4 months after final injection(s) for evidence of new or reoccurring warts and for safety evaluation.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Johnson Dermatology, Fort Smith, Arkansas, United States
Northwest Arkansas Clinical Trials Center PLLC, Rogers, Arkansas, United States
California Dermatology and Clinical Research Institute, Encinitas, California, United States
Silverberg MD Inc., Newport Beach, California, United States
Metro Boston Clinical Partners, LLC, Needham, Massachusetts, United States
BayState Clinical Trials, Watertown, Massachusetts, United States
Hamzavi Dermatology Clinical Trials, Fort Gratiot, Michigan, United States
Minnesota Clinical Study Center, Fridley, Minnesota, United States
Dermatology Consulting Services, High Point, North Carolina, United States
Oregon Medical Research Center, Portland, Oregon, United States
Austin Institute for Clinical Research Inc., Austin, Texas, United States
DermResearch Inc., Austin, Texas, United States
Texas Dermatology and Laser Specialists, San Antonio, Texas, United States
Dermatology Research Center, Inc., Salt Lake City, Utah, United States
The Education and Research Foundation, Inc., Lynchburg, Virginia, United States
Name: Thomas Carpenter, DVM, PhD
Affiliation: Nielsen BioSciences, Inc.
Role: STUDY_DIRECTOR