Safety and Systemic Exposure of YCANTH (VP-102) in Subjects With Common Warts (Verruca Vulgaris) (COVE-5)

Prior treatment

• Systemically immunosuppressed, received required systemic immunosuppressive or immunomodulatory treatment within 30 days before enrollment, or such treatment is planned during the study.
• Received previous treatment for common warts within 30 days before treatment.
• Received immunization within 5 days before or after treatment with study drug.
• Received another investigational product within 30 days before study drug application.

Other illness

• Have chronic or acute medical conditions that may interfere with study results or place the subject at undue risk.
• Have active malignancy or are undergoing treatment for malignancy, other than basal cell carcinoma.
• Have clinically significant medical, psychiatric, or emotional conditions that may compromise safety or data quality.
• Have hypersensitivity to study drug, related compounds, or product excipients.
• Have conditions or situations that may interfere significantly with participation.

Other

• Unable to cooperate with study requirements or visits.
• Have treatable warts that the subject, parent/guardian, or investigator is unwilling to treat.
• Have plantar, genital, anal, or subungual warts, or warts within 10 mm of a mucosal surface proposed for treatment.
• Have epidermodysplasia verruciformis.
• Are sexually active or may become sexually active and are unwilling to comply with protocol-specified contraception requirements. Females who have reached menarche must comply with protocol-specified urine pregnancy testing.
• Are pregnant or breastfeeding.

• Male or female patients aged 2 years or older.
• Immunocompetent.
• Have a minimum of 4 treatable common warts (verruca vulgaris). Warts in the eye area (including eyelids), lips, oral or nasal cavities, inside the ears, soles of the feet, subungual spaces, anogenital area, or within 10 mm of a mucosal surface will not be treated or evaluated.
• Have no systemic or dermatologic disorder that, in the opinion of the investigator, could interfere with the study results or increase the risk of adverse events.
• Agree to refrain from swimming, bathing, or prolonged immersion in water until the study drug is removed after treatment.
• Have the ability, or have a parent/guardian with the ability, to follow study instructions and complete study requirements.
• Agree not to use any wart-removing treatments during the study, except as permitted by the protocol.
• Provide written informed consent or assent and parent/guardian consent as applicable.
• Agree to the required blood draws.