A Phase 3 interventional study of VP-102 (US) / TO-208 (Japan) and Vehicle (US) / Vehicle (Japan) in Common Warts, Common Warts (Verruca Vulgaris) and Human Papilloma Virus (HPV), sponsored by Verrica Pharmaceuticals Inc.. Recruiting at 20 sites in 2 countries. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Verrica Pharmaceuticals Inc. · Phase 3, Interventional, and Treatment
This is a Phase 3, double-blind, randomized, vehicle-controlled study (Study number VP-CW-302; referred to as COVE-3 [Cantharidin and Occlusion in Verruca Epithelium]) to evaluate the efficacy and safety of YCANTH (VP-102/TO-208) treatment in subjects with common warts.
Methodology:
This Phase 3, double-blind, randomized, vehicle-controlled study (Study number VP-CW-302; referred to as COVE-3 [Cantharidin and Occlusion in Verruca Epithelium 3]) includes a Screening Period of up to 60 days, followed by a 75-day Treatment Period, and a 63-day Follow-up Period.
Treatments:
Treatment Visit 1 (Day 1), the day of the first application of study drug (YCANTH [VP-102/TO-208] or Vehicle), may occur on the same day as the Screening Visit. Dermatologic examination, wart measurements, location of all treatable common warts, and evaluation of response to treatment (ERT; as defined in Assessments and procedures) must be repeated if the Screening Visit and Treatment Visit 1 do not coincide. YCANTH (VP-102/TO-208) or Vehicle will be applied by the Investigator or qualified member of the research team. Study drug will be applied to treatable common warts, including an approximate 1 to 2 mm margin of healthy, surrounding skin. Warts are to be treated, then covered with occlusive tape (occlusive tape with similar properties should be used across all clinical sites) that will remain in place overnight and be removed just before the 24 hour evaluation of response to treatment (ERT).
Before application of study drug, wart paring, if necessary, will be completed. If adherent scale is not present, study drug can be applied without paring.
Treatment will continue every 21 (±4) days until complete clearance of all warts or a maximum of 4 treatment sessions during the 75-day treatment period. The exact treatment interval will be determined by evaluation of the treatment site, taking into account ongoing local skin reactions (LSRs), which are defined as temporary local skin reactions (vesiculation, pain, pruritus, scabbing, erythema, discoloration, application site dryness, edema and erosion. that are expected and consistent with historical treatment with YCANTH (VP-102/TO-208). Subjects will be required to return for every treatment and follow-up visit even if their treatable common warts have cleared. Subjects will have an in person visit 24 (± 6) hours after Treatment Visit 1 (first application of study drug). After Treatment Visits 2, 3, and 4 (Days 21, 42, and 63, respectively), telephone follow-up will be conducted 24 to 72 hours after application of study drug. In addition, telephone follow-up will be conducted 7 to10 days after application of study drug after Treatment Visits 1,2,3 and 4. During the telephone calls, a member of the research team will complete ERT assessments and inquire about AEs and concomitant medications.
Assessment for complete clearance (i.e., complete resolution of all common warts as assessed visually by a Blinded Assessor) 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; the visit will be documented as an Unscheduled Visit. The timing of the next visit will be determined by resolution of the LSRs. All LSRs must resolve sufficiently to allow for evaluation of the treatment site. The research team will be in contact with the subject 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. A treatment interval exceeding 21 (± 4) days because of resolving LSRs will not be considered a protocol deviation.
All treatable common warts that are not completely clear should undergo treatment with study drug. No partial treatment of treatable common warts is permitted, unless a subject would be required to exceed the maximum number of 2 applicators per treatment session in order to complete treatment. Each applicator can cover approximately 1500 mm2 for a total of approximately 3000 mm2 using the 2 study drug applicators.
If a subject receives fewer than 4 treatments within the 75-day treatment period because of the duration of post-treatment LSRs, this will not be considered a protocol deviation. No treatment should be administered after the 75-day treatment period without Sponsor approval.
Subjects will be required to attend all visits even if they have achieved complete clearance of all treatable common warts at a previous visit.
Subjects enrolled in Japan in this study (COVE-3) will be eligible to enroll in a Long-Term Follow-up (LTFU) study (Study VP-CW-303 [COVE-4]) to evaluate the safety and efficacy of YCANTH (VP-102/TO-208) over 54 weeks:
In the LTFU study, eligible Japanese subjects will receive open-label YCANTH (VP-102/TO-208) every 21 days until all treatable common warts are clear (for a maximum of 4 additional treatments) or until Day 357, whichever occurs first.
171 studies on the registry are indexed under Warts; 35 are open to participants now.
This study's planned enrollment of 300 is above the median of 70 across 155 interventional studies indexed under Warts.
Browse Warts studies →Verrica Pharmaceuticals Inc. is the lead sponsor of 10 studies on the registry; 3 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Candidates will be included in the study if they:
Have a minimum of 1 treatable common wart (verruca vulgaris) of any size and height:
Exclusion Criteria:
Candidates will be excluded from the study if they:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
US: Topical solution, which is a light violet to dark purple, slightly viscous liquid. Japan: Topical solution, which is clear to yellow, slightly viscous liquid. 0.7% (each mL contains 7 mg of cantharidin)/ glass ampule within an applicator. Each applicator contains 0.45 mL of 0.7% w/v cantharidin. Administered Topical/every 21 (± 4) days. All treatments will take place within a 75-day period.
Combination Product: VP-102 (US) / TO-208 (Japan)
US: Topical solution, which is a light violet to dark purple, slightly viscous liquid. Japan: Topical solution, which is clear to yellow, slightly viscous liquid. No active drug/glass ampule within an applicator. Each applicator contains 0.45 mL without active cantharidin. Administered Topical/every 21 (± 4) days. All treatments will take place within a 75-day period.
Combination Product: Vehicle (US) / Vehicle (Japan)
Drug page: VP-102
A single-use applicator and applied in sufficient quantity to cover the entirety of each treatable common wart, including approximately a 1 to 2 mm margin of surrounding, healthy skin. The contents of no more than 2 applicators may be applied at each treatment visit. Each applicator contains 0.45 mL of 0.7% w/v cantharidin. Occlusive tape (occlusive tape with similar properties should be used across all clinical sites) will be applied to warts that have been treated. Once applied, the occlusive tape should be gently rubbed to maximize adherence to the treated area.
Vehicle is contained in a single-use applicator and applied in sufficient quantity to cover the entirety of each treatable common wart, including approximately a 1 to 2 mm margin of surrounding, healthy skin. The contents of no more than 2 applicators may be applied at each treatment visit. The Vehicle applicator contains the same excipient formulation as the VP-102/TO-208 applicator but does not contain the active pharmaceutical ingredient cantharidin. Occlusive tape (occlusive tape with similar properties should be used across all clinical sites) will be applied to warts that have been treated. Once applied, the occlusive tape should be gently rubbed to maximize adherence to the treated area.
Proportion of subjects achieving complete clearance of all treatable common warts (baseline and new) at the Day 84 (EOT) Visit.
To evaluate the efficacy of YCANTH (VP-102/TO-208) relative to Vehicle by assessing the proportion of subjects achieving complete clearance defined by complete resolution of all common warts as assessed visually by a Blinded Assessor of all treatable common warts, at the EOT Visit (Day 84).
Time frame: Day 84 (0/+8 days)
Proportion of subjects achieving sustained complete clearance of all treatable common warts (baseline and new) from Treatment Visit 4 (Day 63) through EOT Visit (Day 84).
To evaluate the efficacy of YCANTH (VP-102/TO-208) relative to Vehicle by assessing the proportion of subjects achieving sustained complete clearance of all treatable common warts (baseline and new) from Treatment Visit 4 (Day 63) through EOT Visit (Day 84).
Time frame: From Day 63 (+/- 4 days) to Day 84 (0/+8 days)
Proportion of subjects achieving sustained complete clearance of all treatable common warts (baseline and new) from Treatment Visit 3 (Day 42) through EOT Visit (Day 84).
To evaluate the efficacy of YCANTH (VP-102/TO-208) relative to Vehicle by assessing the proportion of subjects achieving sustained complete clearance of all treatable Common warts (baseline and new) from Treatment Visit 3 (Day 42) through EOT Visit (Day 84).
Time frame: From Day 42 (+/- 4 days) to Day 84 (0/+8 days)
Proportion of subjects achieving sustained complete clearance of all treatable common warts (baseline and new) from Treatment Visit 2 (Day 21) through EOT Visit (Day 84).
To evaluate the efficacy of YCANTH (VP-102/TO-208) relative to Vehicle by assessing the proportion of subjects achieving sustained complete clearance of all treatable Common warts (baseline and new) from Treatment Visit 2 (Day 21) through EOT Visit (Day 84).
Time frame: From Day 21 (+/- 4 days) to Day 84 (0/+8 days)
Incidence and severity of adverse events and local skin reactions
Number and percentage of participants experiencing treatment-emergent adverse events (TEAEs), including local skin reactions (LSRs), and assessment of event severity.
Time frame: From enrollment to the end of Study (12 weeks to 21 weeks)
Change from baseline in pulse rate
Change from baseline in pulse rate.
Time frame: Baseline through the end of Study (12 weeks to 21 weeks)
Change from baseline in body temperature
Change from baseline in body temperature.
Time frame: Baseline through the end of Study (12 weeks to 21 weeks)
Concomitant medication use
Number and percentage of participants reporting concomitant medication use during the study.
Time frame: From enrollment to the end of Study (12 weeks to 21 weeks)
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Plan to share: No
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Studies of the drug tested here: VP-102
Verrica Pharmaceuticals Inc.