COVE-2 A Phase 3, Double-blind, Randomized, Vehicle-controlled Study to Evaluate the Efficacy and Safety of YCANTH VP-102 in Subjects With Common Warts Verruca Vulgaris

What this Trial Is About

Researchers are evaluating the safety and effectiveness of YCANTH VP-102, a topical treatment, for people with common warts verruca vulgaris in a Phase 3 clinical trial called COVE-2. This study compares the active treatment to a placebo vehicle and includes participants aged 2 years and older who have at least one treatable common wart. The study aims to understand if YCANTH can clear all treatable warts by the end of the treatment period. The trial includes a Screening Period of up to 60 days, followed by a 75-day Treatment Period and a 63-day Follow-up Period. Participants receive topical applications of YCANTH VP-102 or a placebo every 21 days, up to four treatments. The study drug is applied to warts and a small area of surrounding skin, then covered with occlusive tape overnight. Wart paring may be done before application if needed. Warts are treated completely unless limited by the number of applicators. After each treatment, participants have in-person or telephone follow-ups to assess wart clearance and skin reactions. During the study, participants attend visits for dermatologic exams, wart measurements, and treatment assessments. Follow-up includes visual checks for complete wart clearance, monitoring of local skin reactions, adverse events, and medication use. Even if warts clear early, participants continue scheduled visits until the study ends. After this study, participants may join a long-term follow-up study to further evaluate YCANTH for up to 54 weeks. The primary outcome is the proportion of participants with complete clearance of all treatable warts by Day 84.

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