Actively Recruiting
Long-Term Follow-up Study of Cantharidin (YCANTH [VP-102/TO-208]) in Patients With Common Warts (Verruca Vulgaris)
Led by Verrica Pharmaceuticals Inc. · Updated on 2026-05-05
600
Participants Needed
4
Research Sites
114 weeks
Total Duration
On this page
Sponsors
V
Verrica Pharmaceuticals Inc.
Lead Sponsor
A
Allucent (US) LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
People who participated in either the COVE-2 or COVE-3 study for common warts, may be eligible to enroll into this Long Term Follow Up (LTFU) study COVE-4. The main question(s) to answer in this LTFU study are: * To assess the safety of YCANTH (also known as VP-102 in the United Sates or TO-208 in Japan) by assessing concomitant medication use, and adverse events (AEs), including expected local skin reactions (LSRs). * To evaluate the efficacy of continued skin application of YCANTH (VP-102/TO-208) when applied to each common wart once every 21 days for a maximum of 4 additional treatments. Participants with eligible common warts present will receive YCANTH (VP-102/TO-208) with an interval of 21 (± 4) days between applications until there is a wart count of zero (ie, completed clearance has been achieved) or a maximum of 4 additional treatments. Participants with complete clearance will attend Observation Visits at intervals of 42 (± 4) days without treatment. Participants who develop a new wart after having a wart count of zero will resume Treatment Visits every 21 (± 4) days for a maximum of 4 additional treatments. All subjects will attend visits until the End-of-Study (EOS) Visit, which is on Day 378 (0/+ 8 days). If participants still have warts present after 4 additional treatments of YCANTH (VP-102/TO-208) the wart(s) will be discontinued from study and participants will be allowed to seek treatment but should be limited to destructive therapy such as cryosurgery and warts cannot be within 10 mm of any warts that receive(d) study drug treatment . The exact interval of Treatment Visits will be determined by evaluation of the treatment site, taking into account any ongoing local skin reactions (LSRs), which are defined as temporary application site: vesiculation, pain, pruritus, scabbing, erythema, discoloration, dryness, edema and erosion that is expected and consistent with historical treatment with YCANTH (VP-102/TO-208). Participants may receive treatment until all treatable common warts are clear, up to a maximum of 4 treatment sessions, or until Day 357, whichever occurs first. Treatment: For participants with warts present at the time of study entry, the first treatment application may occur on the same day as transition from the parent study. All required parent study assessments must be complete, including the final evaluation of response to treatment (ERT; as defined in Assessments and procedures). In addition, eligibility for participation in the LTFU study must have been determined, and informed consent/assent for participation in this LTFU study obtained. YCANTH (VP-102/TO-208) will be applied by the Investigator or qualified member of the research team to treatable common warts, including an approximate 1 to 2 mm margin of healthy, surrounding skin. After YCANTH (VP-102/TO- 208) is applied, warts are to be covered with occlusive tape (occlusive tape with similar properties should be used across all clinical sites) that will remain in place overnight and should be removed 24 hours after application of study drug and just before a 24-hour ERT. Before application of study drug, wart paring, if necessary, will be completed with a sharp surgical instrument (eg, scalpel or flexible medical blade) to remove any adherent thick scale from a treatable common wart. Wart paring is required to be performed at any treatment visit when adherent thick scale is present, and the Investigator feels paring can be safely performed. Paring should be conducted by a trained practitioner and in compliance with any local regulations and should be discontinued if it results in punctate bleeding or significant pain. Not all treatable common warts may require paring. If adherent scale is not present, study drug can be applied without paring. The assessment for complete clearance may be made once all treatable common warts are evaluable and not obscured by an ongoing LSR. If the Investigator is unable to evaluate or treat 1 or more warts due to ongoing LSRs, no warts should be treated, and the visit will be documented as an Unscheduled Visit. The timing of the next treatment visit will be determined by resolution of the LSRs. The research team will be in contact with the Participant until all LSRs are resolved. Once LSRs have resolved, a Treatment Visit will be scheduled within 21 (± 4) days of the previous treatment application, noting it may be longer than 21 (± 4) days depending on the length of time until LSR resolution. All treatable common warts that are not completely clear should undergo treatment with study drug. Study duration from Days 84, 105, or 147 of the parent study (COVE-2 or COVE-3) through the final EOS visit of this LTFU study (Day 378) is approximately 294 days.
CONDITIONS
Official Title
Long-Term Follow-up Study of Cantharidin (YCANTH [VP-102/TO-208]) in Patients With Common Warts (Verruca Vulgaris)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Completed Day 84, 105, or 147 visit in the parent study and have at least one treatable common wart if applicable
- Provided written informed consent or assent approved by the Institutional Review Board
- Agree to avoid swimming, bathing, or prolonged water immersion until study drug removal after each treatment
- Have the ability or parent/guardian ability to follow study instructions and complete all requirements
- Agree not to use any other wart-removing products during the study except for excluded wart types treated with limited destructive therapies
- Provided written authorization for use and disclosure of protected health information
- If participating in optional photographic assessment, agree to allow photos of treatable warts at selected visits
You will not qualify if you...
- Unable to cooperate with study requirements or visits
- Have warts in allowed locations they or the investigator do not want to treat
- Are systemically immunosuppressed or have taken systemic immunosuppressive medications within 30 days before enrollment
- Have chronic or acute medical conditions that may interfere with study or increase risk
- Received treatment for common warts, including cantharidin or other listed therapies, within 30 days before treatment
- Received immunizations within 5 days before or after study drug treatment
- Received investigational products unrelated to wart treatment within 30 days before study drug application
- Have epidermodysplasia verruciformis
- Have active malignancy or undergoing malignancy treatment
- Have significant medical, psychiatric, or emotional conditions that compromise safety or data quality
- Have hypersensitivity to YCANTH or its ingredients
- Have conditions interfering with study participation such as requiring hospitalization or substance abuse
- Are sexually active or may become active and unwilling to use responsible birth control methods; females of childbearing potential must have negative pregnancy tests
- Are pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 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
Optima Research Boardman
Boardman, Ohio, United States, 44512
Actively Recruiting
4
Texas Dermatology
San Antonio, Texas, United States, 78235
Actively Recruiting
Research Team
P
Project Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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