COVE-3: A Phase 3, Double-blind, Randomized, Vehicle-controlled Study to Evaluate the Efficacy and Safety of YCANTH (VP-102/TO-208) in Subjects With Common Warts (Verruca Vulgaris)

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.

Description

Eligibility

Age range

2+ years

Sex

All

Healthy volunteers

No

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.

Locations (2)