This Phase 2 study has been designed to determine the safety and efficacy of repeated treatment sessions of VDMN-21 patch at two dose strengths as compared to a matched vehicle control patch in subjects with verruca vulgaris
Protocol 250-12951-201 is a planned Phase 2 study entitled "A Multi-Center, Randomized, Double-Blind, Vehicle-Controlled Study of the Safety and Efficacy of VDMN-21 in Subjects with Verruca Vulgaris". Eligible subjects will be randomized into one of the three treatment groups (high dose, low dose, vehicle).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
153
Microneedle patch containing 125 mcg of active drug
Microneedle patch containing 250 mcg of active drug
Placebo microneedle patch containing no active drug (i.e., placebo)
Site 07
Fort Smith, Arkansas, United States
Site 16
San Diego, California, United States
Site 02
Plainfield, Indiana, United States
Proportion of subjects with complete clinical resolution of the Target Lesion at end of treatment period
Complete clinical resolution is defined as the target lesion with area = 0.
Time frame: Baseline up to Day 134
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Site 13
Louisville, Kentucky, United States
Site 15
Baton Rouge, Louisiana, United States
Site 09
New Brighton, Minnesota, United States
Site 01
Anderson, South Carolina, United States
Site 06
Greenville, South Carolina, United States
Site 11
Knoxville, Tennessee, United States
Site 03
Arlington, Texas, United States
...and 6 more locations