Common WartsPhase 2COVE-5NCT07881952
Safety and Systemic Exposure of YCANTH (VP-102) in Subjects With Common Warts (Verruca Vulgaris) (COVE-5)
A Phase 2 study testing VP-102 in people with Common Warts and Common Warts (Verruca Vulgaris), run by Verrica Pharmaceuticals Inc. at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Common Warts, Common Warts (Verruca Vulgaris), Human Papilloma Virus (HPV)
- What is being tested?
- VP-102
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2026to Apr 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites
Equity Medical Bowling Green
Bowling Green, Kentucky, 42104
Equity Medical Manhattan
New York, New York, 10023
Equity Medical Owensboro
Owensboro, Kentucky, 42303
Equity Medical Bronx
The Bronx, New York, 10455
About this study
Official title: COVE-5: A Phase 2, Open-label Study to Evaluate the Safety and Systemic Exposure of YCANTH (VP-102) in Subjects With Common Warts (Verruca Vulgaris)
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.
- Being tested
- VP-102
- Keywords
- Common Warts, Common Warts (Verruca Vulgaris), Human Papilloma Virus (HPV), Pharmacokinetics
- Medical subject headings
- Warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VP-102Combination product
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 group | Role | What they receive |
|---|---|---|
| VP-102 | Experimental | Topical solution, which is a light violet to dark purple, slightly viscous liquid. Each single-use applicator contains 0.45 mL of 0.7% w/v cantharidin. VP-102 will be administered topically as a single application on Day 1 using no more than 2 applicators. Receives: Combination Product: VP-102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects exhibiting systemic exposure to YCANTH (VP-102)
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.
Measured: Predose, 2 hours, 6 hours, and 24 hours after study drug application
Secondary outcomes (4)
Incidence and severity of adverse events including local skin reactions
Number and percentage of subjects experiencing treatment-emergent adverse events (TEAEs), including local skin reactions (LSRs), and assessment of event severity.
Measured: From study drug application on Day 1 through Day 21
Change from baseline in pulse rate
Change from baseline in pulse rate.
Measured: Baseline through Day 21
Change from baseline in body temperature
Change from baseline in body temperature.
Measured: Baseline through Day 21
Concomitant medication use
Number and percentage of subjects reporting concomitant medication use after study drug application.
Measured: From study drug application on Day 1 through Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common WartsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Verrica Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medidata Solutions, Veeva Systems, Allucent (US) LLC, Myonex LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07881952
- Sponsor's protocol ID
- VP-CW-304
- Acronym
- COVE-5
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No