Starting soon
Phase 2
Safety and Systemic Exposure of YCANTH (VP-102) in Subjects With Common Warts (Verruca Vulgaris) (COVE-5)
Condition(s) studied
Common WartsCommon Warts (Verruca Vulgaris)Human Papilloma Virus (HPV)Warts
Investigational drug(s) / intervention(s)
VP-102
VP-102: YCANTH (VP-102) is supplied as a topical solution containing cantharidin 0.7% w/v in a single-use glass ampule applicator. The solution will be applied to the entirety of each common wart selected for treatment, including an approximate 1 to 2 mm margin of surrounding healthy skin. No more than 2 applicators may be used. Occlusive tape will be applied after the solution has dried and will remain in place overnight until removal at approximately 24 hours.
Study summary
This is a Phase 2, open-label study (Study VP-CW-304; referred to as COVE-5 \[Cantharidin and Occlusion in Verruca Epithelium 5\]) to evaluate the safety and systemic exposure of YCANTH (VP-102) following a single 24-hour dermal application in subjects with common warts.
Eligibility
Inclusion Criteria:
* Male or female patients aged 2 years or older.
* Immunocompetent.
* Have a minimum of 4 treatable common warts (verruca vulgaris). Warts in the eye area (including eyelids), lips, oral or nasal cavities, inside the ears, soles of the feet, subungual spaces, anogenital area, or within 10 mm of a mucosal surface will not be treated or evaluated.
* Have no systemic or dermatologic disorder that, in the opinion of the investigator, could interfere with the study results or increase the risk of adverse events.
* Agree to refrain from swimming, bathing, or prolonged immersion in water until the study drug is removed after treatment.
* Have the ability, or have a parent/guardian with the ability, to follow study instructions and complete study requirements.
* Agree not to use any wart-removing treatments during the study, except as permitted by the protocol.
* Provide written informed consent or assent and parent/guardian consent as applicable.
* Agree to the required blood draws.
Exclusion Criteria:
* Unable to cooperate with study requirements or visits.
* Have treatable warts that the subject, parent/guardian, or investigator is unwilling to treat.
* Have plantar, genital, anal, or subungual warts, or warts within 10 mm of a mucosal surface proposed for treatment.
* Systemically immunosuppressed, received required systemic immunosuppressive or immunomodulatory treatment within 30 days before enrollment, or such treatment is planned during the study.
* Have chronic or acute medical conditions that may interfere with study results or place the subject at undue risk.
* Received previous treatment for common warts within 30 days before treatment.
* Received immunization within 5 days before or after treatment with study drug.
* Received another investigational product within 30 days before study drug application.
* Have epidermodysplasia verruciformis.
* Have active malignancy or are undergoing treatment for malignancy, other than basal cell carcinoma.
* Have clinically significant medical, psychiatric, or emotional conditions that may compromise safety or data quality.
* Have hypersensitivity to study drug, related compounds, or product excipients.
* Have conditions or situations that may interfere significantly with participation.
* Are sexually active or may become sexually active and are unwilling to comply with protocol-specified contraception requirements. Females who have reached menarche must comply with protocol-specified urine pregnancy testing.
* Are pregnant or breastfeeding.
Primary outcome measure(s)
- Proportion of subjects exhibiting systemic exposure to YCANTH (VP-102) — Predose, 2 hours, 6 hours, and 24 hours after study drug application
The proportion of subjects exhibiting systemic cantharidin exposure following a single application of YCANTH (VP-102), based on plasma samples collected before application of study drug and at 2, 6, and 24 hours after application.
Trial sites (4)
| Facility | City | Region | Status |
| Equity Medical Bowling Green |
Bowling Green |
Kentucky |
|
| Equity Medical Owensboro |
Owensboro |
Kentucky |
|
| Equity Medical Manhattan |
New York |
New York |
|
| Equity Medical Bronx |
The Bronx |
New York |
|
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