Trials / Completed
CompletedNCT03487549
Cantharidin and Occlusion in Verruca Epithelium
A Phase 2, Open Label Study to Evaluate the Efficacy, Safety and Tolerability of VP-102 in Subjects With Common Warts (Verruca Vulgaris)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 56 (actual)
- Sponsor
- Verrica Pharmaceuticals Inc. · Industry
- Sex
- All
- Age
- 2 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
- Common Wart
- Warts Hand
- Warts
- Papillomavirus Infections
- DNA Virus Infections
- Skin Diseases, Viral
- Skin Diseases, Infectious
- Skin Diseases
- Virus Diseases
- Tumor Virus Infections
- Verruca Vulgaris
- Verruca
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | VP-102 Cantharidin topical film forming solution | 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. |
| COMBINATION_PRODUCT | VP-102 Cantharidin, topical film forming solution | 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. |
Timeline
- Start date
- 2018-03-27
- Primary completion
- 2019-05-16
- Completion
- 2019-07-15
- First posted
- 2018-04-04
- Last updated
- 2024-11-27
- Results posted
- 2021-09-01
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03487549. Inclusion in this directory is not an endorsement.