Cantharidin Application in Patients With Common Warts (Verruca Vulgaris) (COVE-2)

NCT07246590 | Recruiting Phase 3 FDA Drug

• 1 other identifier: VP-CW-301
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 6

Brief Summary

This is a Phase 3, double-blind, randomized, vehicle-controlled study (Study number VP-CW-301; referred to as COVE-2 \[Cantharidin and Occlusion in Verruca Epithelium\]) to evaluate the efficacy and safety of YCANTH (VP-102) treatment in subjects with common warts.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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) 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).

  Day 84(0/+8 days)

Secondary Outcomes (4)

• 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).

  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).

  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).

  From Day 21 (+/- 4 days) to Day 84 (0/+8 days)

• Incidence and severity of AEs (including LSRs) Change from baseline in vital signs (body temperature, pulse rate). Concomitant medication use.

  From enrollment to the end of Study (12 weeks to 21 weeks)

Study Arms (2)

VP-102

EXPERIMENTAL

Topical solution, which is a light violet to dark purple, 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

Vehicle

PLACEBO COMPARATOR

Topical solution, which is a light violet to dark purple, slightly viscous liquid. No active drug/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: Vehicle

Interventions

VP-102 COMBINATION_PRODUCT

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.

VP-102

Vehicle COMBINATION_PRODUCT

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 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.

Vehicle

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Candidates will be included in the study if they:
• Are male or female patients ≥ 2 years of age.
• Are immunocompetent.
• Have a minimum of 1 treatable common wart (verruca vulgaris) of any size and height:
• Common warts are considered treatable if they are located anywhere on the body, except for the following excluded areas: the eye area (including eyelids), lips, oral cavity, nasal cavity, inside of the ears, soles of the feet (plantar warts), subungual spaces (ie, under the fingernail or toenail), or the anogenital area (warts within 10 mm of a mucosal surface should not be treated).
• 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 10 mm of any warts that are under study.
• Have no systemic or dermatologic disorder, which, in the opinion of the Investigator, will interfere with the study results or increase the risk of AEs.
• Agree to refrain from swimming, bathing, or prolonged immersion in water or any liquids until the study drug is removed after each treatment.
• Have the ability, or have a parent/guardian with the ability, to follow study instructions and the willingness to complete all study requirements.
• Provide written informed consent or assent in a manner approved by the 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 will be required to re-consent to remain on the study.
• Provide written authorization for use and disclosure of protected health information (per state and/or country requirements).
• 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.

You may not qualify if:

• Candidates will be excluded from the study if they:
• Are unable to cooperate with the requirements or visits of the study, as determined by the Investigator.
• Have any warts present at Baseline in an allowed anatomic location that the subject, parent/guardian, or Investigator is unwilling to treat.
• Plantar warts and external genital warts will not be included in this study, in addition, subungual warts and warts within 10 mm of a mucosal surface will not be included in this study due to their anatomical location and complex treatment modalities.
• Are systemically immunosuppressed or have taken required systemic immunosuppressive or immunomodulatory medication (including oral or parenteral corticosteroids) 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.
• 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, human immunodeficiency virus, systemic lupus erythematosus, viral hepatitis, uncontrolled diabetes).
• Have 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 90 days before treatment.
• Have more common warts, or wart area, to be treated than can be adequately covered with the contents of 2 study drug applicators, as determined by total wart surface area. Each applicator can cover approximately 1500 mm2 for a total of approximately 3000 mm2 using the 2 study drug applicators.
• Immunizations (eg, flu shots) may be administered throughout the study, but not within 5 days before or after any treatment with study drug and will be recorded as concomitant therapies in the eCRF.
• 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.
• Have epidermodysplasia verruciformis.
• Have an active malignancy or are undergoing treatment for any malignancy.
• Have a history or presence of clinically significant medical, psychiatric, or emotional condition or abnormality that, in the opinion of the Investigator, would compromise the safety of the subject or the quality of the data.
• Have a history or presence of hypersensitivity or an idiosyncratic reaction to the study drug or related compounds, or drug product excipients (acetone, ethyl alcohol, nitrocellulose, hydroxypropyl cellulose, castor oil, camphor, gentian violet, and denatonium benzoate).
• Have a condition or situation that may interfere significantly with the subject's participation in the study (eg, subjects who required hospitalization in the 2 months before screening for an acute or chronic condition including alcohol or drug abuse), as determined by the Investigator.

Sponsors & Collaborators

• Medidata Solutions: collaborator
• Veeva Systems: collaborator
• Torii Pharmaceutical Co. Ltd.: collaborator
• Allucent (US) LLC: collaborator
• Myonex LLC: collaborator
• Verrica Pharmaceuticals Inc.: lead
• Canfield Scientific Inc.: collaborator

Study Sites (6)

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

Anne Arundel Dermatology, PA dba Maryland Dermatology Laser Skin & Vein

Hunt Valley, Maryland, 31030, United States

RECRUITING

Tennessee Clinical Research Center, Inc.

Nashville, Tennessee, 37215, United States

RECRUITING

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

NOT YET RECRUITING

Texas Dermatology and Laser Specialists

San Antonio, Texas, 78218, United States

RECRUITING

MeSH Terms

Conditions

Warts

Interventions

VP-102

Condition Hierarchy (Ancestors)

Papillomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Tumor Virus Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Project Manager

CONTACT

484-453-3295; 17338-COVE2@allucent.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 24, 2025
• Study Start: December 17, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)