This is a Phase 2, open label study (Study number VP-102-105; referred to as COVE-1 \[Cantharidin and Occlusion in Verruca Epithelium\]) to evaluate the efficacy, safety and tolerability of VP-102 treatment in subjects with common warts. This study has two Cohorts.
The first Cohort (Cohort 1) utilizes a treatment interval of at least 14 days between treatments with longer treatment intervals being allowed depending on a specific patient's clinical response.Twenty Subjects (2 years and older) are targeted completing End of Study (EOS) visit in Cohort 1. The second Cohort (Cohort 2) utilizes a treatment interval of 21 days between treatments. Paring of lesions is allowed. Approximately 35 subjects (12 years and older) will be enrolled in Cohort 2. Up to 4 sites will participate in the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
56
VP-102, a single-use drug device combination product containing (cantharidin) topical solution, 0.7% (w/v). Treatment interval of at least 14 days between treatments.
VP-102, a single-use drug device combination product containing (cantharidin) topical solution, 0.7% (w/v). Treatment interval of at least 21 days between treatments.
Cohort 2: Applied Research Center of Arkansas
Little Rock, Arkansas, United States
Cohort 2: Solutions Through Advanced Research
Jacksonville, Florida, United States
Cohort 2: The Indiana Clinical Trials Center
Plainfield, Indiana, United States
Cohort 2: Clarkston Skin Research
Clarkston, Michigan, United States
Cohort 1-Wake Research Associates
Raleigh, North Carolina, United States
Cohort 1: Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at the EOS Visit (Day 84)
Cohort 1: Proportion of subjects exhibiting complete clearance of all treatable warts (baseline and new) at the EOS Visit (Day 84).
Time frame: Treatment Visit Day 1 (Baseline) compared to Day 84 (EOS) Visit.
Cohort 2: Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at the EOT Visit (Day 84)
Cohort 2: Proportion of subjects exhibiting complete clearance of all treatable warts (baseline and new) at the EOT Visit (Day 84).
Time frame: Compare Treatment Visit 1 (Baseline) to EOT Visit (Day 84)
Cohort 1: Change From Baseline in the Number of Treatable Warts (Baseline and New) at the EOS Visit (Day 84)
Cohort 1: Change from baseline in the number of treatable warts (baseline and new) at the EOS Visit (Day 84).
Time frame: Change in the number of warts compared at Baseline (Visit 1) to the End of Study Visit (Day 84).
Cohort 1: Percent Change From Baseline in the Number of Treatable Warts (Baseline and New) at the EOT Visit (Day 84).
Cohort 1: Assessing the percent change from Baseline in the number of treatable warts (Baseline and new) at the EOT visit (Day 84).
Time frame: Baseline (Visit 1) to End of Treatment Visit (Day 84).
Cohort 1: Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at Visit 2, Visit 3, Visit 4 and Over the Duration of the Study
Cohort 1: Proportion of subjects exhibiting complete clearance of all treatable warts (baseline and new) at Visit 2, Visit 3, Visit 4 and over the duration of the study.
Time frame: Baseline, Day 14, 28, 42 and 84 (EOS)
Cohort 2: Change From Baseline in the Number of Treatable Warts (Baseline and New) at the EOT Visit Day 84)
Cohort 2: Change from baseline in the number of treatable warts (baseline and new) at the EOT Visit Day 84).
Time frame: Baseline, Day 84 (EOS)
Cohort 2: Change From Baseline in the Percent of Treatable Warts (Baseline and New) at the EOT Visit (Day 84)
Cohort 2: Change from baseline in the percent of treatable warts (baseline and new) at the EOT Visit (Day 84).
Time frame: Baseline (Visit 1) to End of Treatment Visit (Day 84).
Cohort 2: Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts, (Baseline and New), at Visit 2, Visit 3, Visit 4 and Over the Duration of the Study
Cohort 2: Proportion of subjects exhibiting complete clearance of all treatable warts, (baseline and new), at Visit 2, Visit 3, Visit 4 and over the duration of the study.
Time frame: Baseline, Day 21, 42, 63, and 84 (EOS), 105, 126, and 147
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