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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
243
Candida albicans Skin Test Antigen for Cellular Hypersensitivity
0.9% Sodium Chloride Injection USP (non-preserved)
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
...and 5 more locations
Number of Subjects With Complete Resolution of a Primary Injected Wart(s) at Any Treatment or Follow-up Visit
Complete resolution of a wart was defined as the absence of visible or measurable presence of the wart
Time frame: 45 weeks
Number of Subjects With a Complete Resolution of All Common Warts at Any Treatment or Follow-up Visit
Complete resolution of a wart was defined as the absence of visible or measurable presence of the wart
Time frame: 45 weeks
Number of Subjects With Complete Resolution of Primary Injected Wart(s) at the 4 Month Follow-up Visit
Complete resolution of a wart was defined as the absence of visible or measurable presence of the wart
Time frame: 4 month follow up visit at 45 weeks
Number of Injection Visits Needed to Obtain Complete Resolution of the Primary Injected Wart(s)
Complete resolution of a wart was defined as the absence of visible or measurable presence of the wart
Time frame: 45 weeks
Number of Injection Visits for >50% Reduction in Area of the Primary Injected Wart(s)
Time frame: 45 weeks
Number of Injection Visits to >50% Reduction in the Total Area of All Measured Warts
Time frame: 45 weeks
Number of Subjects With Scarring at the Site of Resolved Primary and Non-primary Injected Wart(s)
Scarring at any visit, many reports were transient being noted at only one or two visits and noted as resolving during the course of the study
Time frame: 45 weeks
Number of Subjects With Hypopigmentation at the Site of Resolved Primary and Non-primary Injected Wart(s)
Time frame: 45 weeks
Number of Subjects With Injection Site Reactions With Frequency Greater Than 5%
Time frame: 45 weeks
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