Cantharidin Application in Patients With Common Warts (Verruca Vulgaris) (COVE-3)

Summary

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.

Conditions

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

Interventions

COMBINATION_PRODUCT

VP-102 (US) / TO-208 (Japan)

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.

COMBINATION_PRODUCT

Vehicle (US) / Vehicle (Japan)

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.

Sponsors & Collaborators

• Torii Pharmaceutical Co. Ltd.

  collaborator UNKNOWN

• CMIC Co, Ltd. Japan

  collaborator INDUSTRY

• Canfield Scientific Inc.

  collaborator INDUSTRY

• Medidata Solutions

  collaborator INDUSTRY

• Veeva Systems

  collaborator INDUSTRY

• Allucent (US) LLC

  collaborator UNKNOWN

• Myonex LLC

  collaborator UNKNOWN

• Verrica Pharmaceuticals Inc.

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

2 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-15

Primary Completion

2027-05-31

Completion

2027-07-31

FDA Drug

Yes

Countries

• United States
• Japan

Study Locations