ClinicalTrials.gg
RecruitingNCT07457918COVE-4Updated Oct 22, 2026

Long-Term Follow-up Study of Cantharidin (YCANTH [VP-102/TO-208]) in Patients With Common Warts (Verruca Vulgaris)

A Phase 3 interventional study of Cantharidin in Common Warts (Verruca Vulgaris), Common Warts and Human Papilloma Virus (HPV), sponsored by Verrica Pharmaceuticals Inc.. Recruiting at 12 sites in 2 countries. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.

Sponsored by Verrica Pharmaceuticals Inc. · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2026; still recruiting 8 months later.
Updated Oct 22, 2026First site in JapanPrimary completion moved+4 moreGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
250
Allocation
Not applicable
Ages
2 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Common Warts (Verruca Vulgaris)
  • Common Warts
  • Human Papilloma Virus (HPV)
  • Warts

Browse trials for

Keywords

  • Common Warts (Verruca Vulgaris)
  • Common Warts
  • Human Papilloma Virus (HPV)
03

In context

Warts

171 studies on the registry are indexed under Warts; 35 are open to participants now.

This study's planned enrollment of 250 is above the median of 70 across 155 interventional studies indexed under Warts.

Browse Warts studies →

Lead sponsor

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.

04

Who can participate

The criteria were revised on the registry on Oct 22, 2026. See what changed

Ages eligible
2 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

Candidates will be included in the study if they:

  1. Meet ≥ 1 of the following criteria:

    1. Completed the Day 84 visit in the parent study and have ≥ 1 treatable common warts.
    2. Completed the Day 105 visit in the parent study and have ≥ 1 treatable common warts.
    3. Completed the Day 147 visit in the parent study.
  2. Provide written or assent in a manner approved by the Institutional Review Board (IRB) and/or have a parent/guardian provide written informed consent as evidenced by the signature on an IRB approved assent/consent form. Subjects who turn 18 years of age (or legal age per state or country) during the study may be required to re consent to remain on the study (follow the state or country regulatory requirements).
  3. Agree to refrain from swimming, bathing, or prolonged immersion in water or any liquids until the study drug is removed after each treatment.
  4. Have the ability, or have a parent/guardian with the ability, to follow study instructions and the willingness to complete all study requirements.
  5. Agree not to use any wart-removing product (prescription or over-the-counter) other than the study drug during the course of the study with the exception of circumstances for excluded wart types. Excluded warts include common warts located in excluded areas that will not be treated or evaluated during the study as well as genital, plantar, or anal warts:

    a. If treatment of these excluded wart types is required during the study, it should be limited to destructive therapy such as cryosurgery and warts cannot be within 10mm of any warts that are under study.

  6. Provide written authorization for use and disclosure of protected health information (per state and/or country requirements).
  7. If participating in the optional photographic assessment, agree to allow photographs of treatable common warts to be taken at selected visits by the research team.

Exclusion criteria

Exclusion Criteria:

Candidates will be excluded from the study if they:

  1. Are unable to cooperate with the requirements or visits of the study, as determined by the Investigator.
  2. Have any warts present at study entry in an allowed anatomic location that the subject, parent/guardian, or Investigator is unwilling to treat.
  3. Are systemically or have taken required systemic immunosuppressive or immunomodulatory medication (including oral or parenteral ) within 30 days before enrollment or such treatment is planned to be required during the course of the study. Routine use of local (eg, topical, inhaled, intranasal) corticosteroids and episodic use of systemic medications to treat conditions arising during the study is allowed.
  4. Have any chronic or acute medical condition that, in the opinion of the Investigator, may interfere with the study results or place the subject at undue risk (eg, , systemic lupus erythematosus, viral hepatitis, uncontrolled diabetes).
  5. Have had any previous treatment (including an agent in a clinical trial) of common warts, including but not limited to the use of cantharidin, imiquimod, antivirals, retinoids, topical salicylic acid, lactic acid, hydrogen peroxide, trichloroacetic acid, pulse dye laser, iodine-based or nitric oxide-based therapies, oral cimetidine, coix seed, intralesional immunotherapy, curettage, or freezing of warts in the 90 days before treatment.
  6. Immunizations (eg, flu shots) may be administered throughout the study, but not within 5 days before or after any treatment with study drug.
  7. Have received any investigational product as part of a clinical trial NOT related to the treatment of common warts within 30 days before the first application of the study drug.
  8. Have epidermodysplasia verruciformis.
  9. Have an active or are undergoing treatment for any malignancy other than basal cell carcinoma.
  10. Have a medical, psychiatric, emotional condition, or abnormality that, in the opinion of the Investigator, would compromise the safety of the subject or the quality of the data.
  11. Have a or an idiosyncratic reaction to YCANTH (VP-102/TO-208) or related compounds, or drug product (acetone, ethyl alcohol, nitrocellulose, hydroxypropyl cellulose, castor oil, camphor, gentian violet, and denatonium benzoate).
  12. Have a condition or situation that may interfere significantly with the subject's participation in the study (eg, subjects who require hospitalization for an acute or chronic condition including alcohol or drug abuse), at the determination of the Investigator.
  13. Are sexually active or may become sexually active and are unwilling to practice responsible methods (eg., combination of condoms and foam, birth control pills, intrauterine device, patch, shot and vaginal ring). Withdrawal is not an acceptable method of birth control. Females who have reached menarche must have a negative urine pregnancy test at each visit before treatment with YCANTH (VP-102/TO-208).
  14. Are pregnant or breastfeeding.
Terms in these criteria, in plain language(10)

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.

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.

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.

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.

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.

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.

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.

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.

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.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

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.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
250 participants (estimated)

Study arms

  • Experimental
    VP-102/TO-208

    Combination Product: Cantharidin

    Combination Product: Cantharidin

Interventions

  • Combination productCantharidin

    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.

06

What researchers measure

Primary outcomes

  1. Incidence and severity of AEs including LSRs.

    To assess the safety of YCANTH (VP-102/TO-208) by assessing adverse events (AEs), including expected local skin reactions (LSRs).

    Time frame: Day of transition to this LTFU study to End of Study Visit Day 378.

  2. Change from baseline in vital signs (body temperature)

    To assess the safety of YCANTH (VP-102/TO-208) by assessing the change from baseline body temperature.

    Time frame: Day of transition to this LTFU study to End of Study Visit Day 378.

  3. Change from baseline in vital signs (pulse)

    To assess the safety of YCANTH (VP-102/TO-208) by assessing the change in baseline in vital signs (pulse).

    Time frame: Day of transition to this LTFU study to End of Study Visit Day 378.

  4. Concomitant medication use

    To assess the safety of YCANTH (VP-102/TO-208) by assessing concomitant medication use.

    Time frame: Day of transition to this LTFU study to End of Study Visit Day 378.

  5. Proportion of subjects achieving clearance (reduction to zero) at the Day 378 EOS Visit of all treatable warts present at Baseline*

    To evaluate the efficacy of continued dermal application of YCANTH (VP-102/TO-208) when applied to each common wart once every 21 days for a maximum of 4 additional treatments. \*Baseline in the study will be either 1) Treatment Visit 1 (Day 1) of the parent study for subjects who received YCANTH (VP-102/TO-208) during the parent study; 2) the first Treatment Visit of this study for subjects who received Vehicle in the parent study; or 3) Treatment Visit 1 of the parent study for subjects who received Vehicle in the parent study and did not receive YCANTH (VP-102/TO-208) during this study.

    Time frame: Baseline* to End of Study Visit Day 378.

Secondary outcomes

  1. Proportion of subjects achieving clearance of all treatable warts at each Treatment Visit after transition to this LTFU study.

    To evaluate the efficacy of YCANTH (VP-102/TO-208) by assessing the proportion of subjects achieving clearance (reduction to zero) of all treatable warts at each Treatment Visit after transition to the long-term follow-up (LTFU) study and by the Day 378 EOS Visit.

    Time frame: Each Treatment Visit in this study (up to 4) and by the End of Study visit Day 378

  2. Mean percent change from baseline in the number of treatable warts present at the Day 378 EOS Visit.

    To evaluate the efficacy of YCANTH (VP-102/TO-208) by assessing the change from baseline to the Day 378 EOS Visit in the number of treatable warts. \*Baseline in the study will be either 1) Treatment Visit 1 (Day 1) of the parent study for subjects who received YCANTH (VP-102/TO-208) during the parent study; 2) the first Treatment Visit of this study for subjects who received Vehicle in the parent study; or 3) Treatment Visit 1 of the parent study for subjects who received Vehicle in the parent study and did not receive YCANTH (VP-102/TO-208) during this study.

    Time frame: Baseline to End of Study Visit Day 378.

07

Study locations

12 of 12 sites recruiting
  • Florida Center for Dermatology, P.A.
    Saint Augustine, Florida 32080, United States
    Recruiting
  • The Indiana Clinical Trials Center, PC
    Plainfield, Indiana 46168, United States
    Recruiting
  • Delricht Research at Touro Medical Center
    New Orleans, Louisiana 70115, United States
    Recruiting
  • Maryland Dermatology Laser Skin & Vein
    Hunt Valley, Maryland 31030, United States
    Recruiting
  • US Dermatology Partners
    Rockville, Maryland 20850, United States
    Recruiting
  • Michigan Center for Research Company
    Clarkston, Michigan 48346, United States
    Recruiting
  • Skin Specialist, PC dba Schlessinger MD
    Omaha, Nebraska 68144, United States
    Recruiting
  • Optima Research Boardman
    Boardman, Ohio 44512, United States
    Recruiting
  • Delricht Research at Grassroots Healthcare
    Tulsa, Oklahoma 74133, United States
    Recruiting
  • Texas Dermatology
    San Antonio, Texas 78235, United States
    Recruiting
  • Ohyama Dermatology Clinic
    Kumamoto, Kumamoto 861-4101, Japan
    Recruiting
  • Tampopo Dermatology Clinic
    Tokyo, Tokyo 143-0023, Japan
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Sites
8 sites added — first site in Japan
Show 8 added (6 United States, 2 Japan)
  • Delricht Research at Touro Medical Center · New Orleans, United States
  • Maryland Dermatology Laser Skin & Vein · Hunt Valley, United States
  • US Dermatology Partners · Rockville, United States
  • Michigan Center for Research Company · Clarkston, United States
  • Skin Specialist, PC dba Schlessinger MD · Omaha, United States
  • Delricht Research at Grassroots Healthcare · Tulsa, United States
  • Ohyama Dermatology Clinic · Kumamoto, Japan
  • Tampopo Dermatology Clinic · Tokyo, Japan
Oct 22, 2026
Primary completion
Apr 30, 2028→Nov 2027
Oct 22, 2026
Study completion
May 22, 2028→Nov 2027
Oct 22, 2026
Enrollment
600→250
Oct 22, 2026
Eligibility
2 exclusion criteria edited
What changed in the criteria
Exclusion criteria
  • EditedHave had any previous treatment (including an investigational agent in a clinical trial) of common warts, including but not limited to the use of cantharidin, imiquimod, antivirals, retinoids, topical salicylic acid, lactic acid, hydrogen peroxide, trichloroacetic acid, pulse dye laser, iodine-based or nitric oxide-based therapies, oral cimetidine, coix seed, intralesional immunotherapy, curettage, or freezing of warts in the 3090 days before treatment.
  • EditedHave an active malignancy or are undergoing treatment for any malignancy other than basal cell carcinoma.
Oct 22, 2026
Show all 1 update
  1. Oct 22, 2026
    8 sites added — first site in Japan
    Show 8 added (6 United States, 2 Japan)
    • Delricht Research at Touro Medical Center · New Orleans, United States
    • Maryland Dermatology Laser Skin & Vein · Hunt Valley, United States
    • US Dermatology Partners · Rockville, United States
    • Michigan Center for Research Company · Clarkston, United States
    • Skin Specialist, PC dba Schlessinger MD · Omaha, United States
    • Delricht Research at Grassroots Healthcare · Tulsa, United States
    • Ohyama Dermatology Clinic · Kumamoto, Japan
    • Tampopo Dermatology Clinic · Tokyo, Japan
    Primary completion Apr 30, 2028→Nov 2027
    Study completion May 22, 2028→Nov 2027
    Enrollment 600→250
    Eligibility 2 exclusion criteria edited
    What changed in the criteria
    Exclusion criteria
    • EditedHave had any previous treatment (including an investigational agent in a clinical trial) of common warts, including but not limited to the use of cantharidin, imiquimod, antivirals, retinoids, topical salicylic acid, lactic acid, hydrogen peroxide, trichloroacetic acid, pulse dye laser, iodine-based or nitric oxide-based therapies, oral cimetidine, coix seed, intralesional immunotherapy, curettage, or freezing of warts in the 3090 days before treatment.
    • EditedHave an active malignancy or are undergoing treatment for any malignancy other than basal cell carcinoma.
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07457918
Lead sponsor
Verrica Pharmaceuticals Inc.
Collaborators
Allucent (US) LLC, Myonex, Canfield Scientific Inc., Medidata Solutions, Veeva Systems, CMIC Co, Ltd. Japan, Torii Pharmaceuticals CO., LTD
Responsible party
Sponsor
First posted
Mar 9, 2026
Start date
Mar 11, 2026
Primary completion
Nov 2027 (estimated)
Completion
Nov 2027 (estimated)
Last update
Oct 22, 2026

Study contacts

Project Manager
Contact
17340-COVE4@allucent.com
484-453-3295
Adelaide A Hebert, MD
principal investigator · UTHealth McGovern Medical School - Houston

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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