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

Inclusion Criteria:

• Subject is a male or non-pregnant female, 9 to 65 years of age.

• Subject has provided written informed consent/assent.

• Females must be post-menopausal, surgically sterile, or use an effective method ofbirth control. Women of childbearing potential (WOCBP) must have a negative urinepregnancy test (UPT) at Visit 1/Baseline.

• Subject has at least 1 and up to 8 common warts (verruca vulgaris),

• Subject is willing to undergo test article therapy as directed, comply with studyinstructions (including availability to a smart phone or equivalent device fortelehealth visit requirements), and commit to all follow-up visits for the durationof the study.

• Subject is in good general health and free of any disease state or physicalcondition that might impair evaluation of the identified warts and/or treatment areaor exposes the subject to an unacceptable risk by study participation.

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 toenrollment or during the course of the study.

• Subject has received 3 or more prior treatments to the Target Lesion withoutresolution.

• Subject received any of the following therapies within the specified wash-out periodprior 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 theopinion 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 evaluationof the Target Lesion, in the opinion in the investigator.

• Subject has a significant autoimmune condition or is immunocompromised based ontheir medical condition (e.g., HIV, malignancy, etc.), medication use, or otherfactors. Routine use of inhaled, intranasal or ophthalmologic corticosteroids duringthe study is allowed.

• Subject has received systemic immunosuppressive therapy such as steroids,methotrexate, cyclosporine, tacrolimus, chemotherapy, etc. within in 4 weeks priorto Baseline.

• Subject has any active malignancy or are undergoing treatment for any malignancyother than nonmelanoma skin cancer;

• Subject has history of significant ophthalmologic inflammatory disease, includinguveitis.

• Subject is currently enrolled in an investigational drug, biologic, or device study.

• Subject has used an investigational drug, investigational biologic, orinvestigational device treatment within 30 days prior to Visit 1/Baseline.

• Subject has a history of allergy or sensitivity to this antigen extract or similarproducts.