Actively Recruiting
COVE-2: A Phase 3, Double-blind, Randomized, Vehicle-controlled Study to Evaluate the Efficacy and Safety of YCANTH (VP-102) in Subjects With Common Warts (Verruca Vulgaris)
Led by Verrica Pharmaceuticals Inc. · Updated on 2026-01-21
300
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
Sponsors
V
Verrica Pharmaceuticals Inc.
Lead Sponsor
C
Canfield Scientific Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of YCANTH (VP-102), a topical treatment, for people with common warts (verruca vulgaris) in a Phase 3 clinical trial called COVE-2. This study compares the active treatment to a placebo (vehicle) and includes participants aged 2 years and older who have at least one treatable common wart. The study aims to understand if YCANTH can clear all treatable warts by the end of the treatment period. The trial includes a Screening Period of up to 60 days, followed by a 75-day Treatment Period and a 63-day Follow-up Period. Participants receive topical applications of YCANTH (VP-102) or a placebo every 21 days, up to four treatments. The study drug is applied to warts and a small area of surrounding skin, then covered with occlusive tape overnight. Wart paring may be done before application if needed. Warts are treated completely unless limited by the number of applicators. After each treatment, participants have in-person or telephone follow-ups to assess wart clearance and skin reactions. During the study, participants attend visits for dermatologic exams, wart measurements, and treatment assessments. Follow-up includes visual checks for complete wart clearance, monitoring of local skin reactions, adverse events, and medication use. Even if warts clear early, participants continue scheduled visits until the study ends. After this study, participants may join a long-term follow-up study to further evaluate YCANTH for up to 54 weeks. The primary outcome is the proportion of participants with complete clearance of all treatable warts by Day 84.
CONDITIONS
Brief Title
Cantharidin Application in Patients With Common Warts (Verruca Vulgaris) (COVE-2)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 2 years or older
- Immunocompetent individuals
- Have at least one treatable common wart (verruca vulgaris) excluding areas such as eyes, lips, mouth, nose, ears, soles of feet, under nails, and genital area
- No systemic or skin disorders that could interfere with study results or increase risk
- Agree to avoid swimming, bathing, or prolonged water immersion until study drug is removed after treatment
- Ability and willingness to follow study instructions and complete all requirements
- Agree not to use other wart-removing products during the study except as allowed
- Provide written informed consent or assent, with parental consent if applicable
- Provide authorization for use and disclosure of health information
- Agree to optional wart photography at selected visits
You will not qualify if you...
- Unable to cooperate with study requirements or visits
- Have warts in allowed areas that are unwilling to be treated
- Presence of plantar, external genital, subungual, or warts within 10 mm of mucosal surfaces
- Systemic immunosuppression or recent immunosuppressive medication use within 30 days
- Chronic or acute medical conditions that may interfere with study or increase risk
- Wart treatments within 90 days before study including cantharidin or other therapies
- Wart area too large to be treated with two applicators
- Immunizations within 5 days before or after treatment
- Participation in other investigational product trials within 30 days
- Epidermodysplasia verruciformis
- Active cancer or cancer treatment
- Medical, psychiatric, or emotional conditions compromising safety or data quality
- Hypersensitivity to study drug or excipients
- Conditions interfering with study participation such as recent hospitalization or substance abuse
- Females unwilling to use effective birth control or who are pregnant or breastfeeding
- Positive pregnancy test at each treatment visit for females who have reached menarche
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 60 days
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 75 days
Participants receive topical application of study drug or vehicle to treat common warts. Treatments occur every 21 (±4) days for up to 4 sessions within 75 days. After each treatment, occlusive tape is applied and removed the next day during an in-person or telephone follow-up to assess response and side effects.
Up to 4 in-person treatment visits every 21 (±4) days; 1 in-person visit 24 hours after first treatment; telephone follow-ups 24 to 72 hours and 7 to 10 days after each treatment
Duration - 63 days
Participants are followed for an additional 63 days after treatment to assess complete clearance of warts and monitor safety outcomes.
In-person visits on Day 84 and telephone follow-ups on Days 105 and 147
Trial Site Locations
Total: 6 locations
1
Florida Center for Dermatology, P.A.
Saint Augustine, Florida, United States, 32080
Actively Recruiting
2
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, United States, 46168
Actively Recruiting
3
Anne Arundel Dermatology, PA dba Maryland Dermatology Laser Skin & Vein
Hunt Valley, Maryland, United States, 31030
Actively Recruiting
4
Tennessee Clinical Research Center, Inc.
Nashville, Tennessee, United States, 37215
Actively Recruiting
5
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Not Yet Recruiting
6
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States, 78218
Actively Recruiting
Research Team
P
Project Manager
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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