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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

2 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• VP-102 (US) / TO-208 (Japan) — 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.
• Vehicle (US) / Vehicle (Japan) — 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/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.

Study Details

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.

Key Dates

First listed

Jun 10, 2026

Start date

Jun 15, 2026

Status verified

Aug 2026

Primary completion

May 31, 2027

Completion

Jul 31, 2027

Study Design

Enrollment

300 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 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. 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.
• Placebo Comparator: Vehicle (US) / Vehicle (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.

Primary Outcome Measure

Proportion of subjects achieving complete clearance of all treatable common warts (baseline and new) at the Day 84 (EOT) Visit. [ Time Frame: Day 84 (0/+8 days) ]

Central Contacts

• Project Manager
  484-453-3295
  [email protected]

Locations (12)

Find similar trials in San Diego, CA

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