Safety and Efficacy of VDMN-21 Patch in Subjects With Common Warts

Exclusion Criteria

• •Subject is pregnant, lactating, or is planning to become pregnant during the study.
• •Subject used or will use oral zinc and/or cimetidine within 30 days prior to enrollment or during the course of the study.
• •Subject has received 3 or more prior treatments to the Target Lesion without resolution.
• •Subject received any of the following therapies within the specified wash-out period prior to Baseline in the treatment area of the Target Lesion
• •1. LASER, light or other energy-based therapy (e.g., intense pulsed light \[IPL\], PDT; 12 weeks
• •2. Immunotherapy (e.g., imiquimod, squaric acid dibutyl ester \[SADBE\], etc.), retinoids, hydrogen peroxide; 12 weeks
• •3. Cryotherapy, biopsy, electrodessication, curettage, antimetabolite therapy (e.g., 5- fluorouracil), cantharidin, or any other treatment that in the opinion of the Investigator may affect the Target Lesion; 6 weeks
• •4. Over-the-counter (OTC) wart therapies, paring ± occlusion; 1 week
• •Subject has scars, tattoos, or other features that may interfere with the evaluation of the Target Lesion, in the opinion in the investigator.
• •Subject has a significant autoimmune condition or is immunocompromised based on their medical condition (e.g., HIV, malignancy, etc.), medication use, or other factors. Routine use of inhaled, intranasal or ophthalmologic corticosteroids during the study is allowed.
• •Subject has received systemic immunosuppressive therapy such as steroids, methotrexate, cyclosporine, tacrolimus, chemotherapy, etc. within in 4 weeks prior to Baseline.
• •Subject has any active malignancy or are undergoing treatment for any malignancy other than nonmelanoma skin cancer;
• •Subject has history of significant ophthalmologic inflammatory disease, including uveitis.
• •Subject is currently enrolled in an investigational drug, biologic, or device study.
• •Subject has used an investigational drug, investigational biologic, or investigational device treatment within 30 days prior to Visit 1/Baseline.
• •Subject has a history of allergy or sensitivity to this antigen extract or similar products.