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

Methodology:

This Phase 3, double-blind, randomized, vehicle-controlled study (Study number VP-CW-302; referred to as COVE-3 \[Cantharidin and Occlusion in Verruca Epithelium 3\]) includes a Screening Period of up to 60 days, followed by a 75-day Treatment Period, and a 63-day Follow-up Period.

Treatments:

Treatment Visit 1 (Day 1), the day of the first application of study drug (YCANTH \[VP-102/TO-208\] or Vehicle), may occur on the same day as the Screening Visit. Dermatologic examination, wart measurements, location of all treatable common warts, and evaluation of response to treatment (ERT; as defined in Assessments and procedures) must be repeated if the Screening Visit and Treatment Visit 1 do not coincide. YCANTH (VP-102/TO-208) or Vehicle will be applied by the Investigator or qualified member of the research team. Study drug will be applied to treatable common warts, including an approximate 1 to 2 mm margin of healthy, surrounding skin. Warts are to be treated, then covered with occlusive tape (occlusive tape with similar properties should be used across all clinical sites) that will remain in place overnight and be removed just before the 24 hour evaluation of response to treatment (ERT).

Before application of study drug, wart paring, if necessary, will be completed. If adherent scale is not present, study drug can be applied without paring.

Treatment will continue every 21 (±4) days until complete clearance of all warts or a maximum of 4 treatment sessions during the 75-day treatment period. The exact treatment interval will be determined by evaluation of the treatment site, taking into account ongoing local skin reactions (LSRs), which are defined as temporary local skin reactions (vesiculation, pain, pruritus, scabbing, erythema, discoloration, application site dryness, edema and erosion. that are expected and consistent with historical treatment with YCANTH (VP-102/TO-208). Subjects will be required to return for every treatment and follow-up visit even if their treatable common warts have cleared. Subjects will have an in person visit 24 (± 6) hours after Treatment Visit 1 (first application of study drug). After Treatment Visits 2, 3, and 4 (Days 21, 42, and 63, respectively), telephone follow-up will be conducted 24 to 72 hours after application of study drug. In addition, telephone follow-up will be conducted 7 to10 days after application of study drug after Treatment Visits 1,2,3 and 4. During the telephone calls, a member of the research team will complete ERT assessments and inquire about AEs and concomitant medications.