Exploratory Study of Efficacy and Safety of Ingenol Mebutate 0.05% Gel for Common Warts on the Hands.

Exclusion Criteria

• •1. Subject is pregnant, lactating, or is planning to become pregnant during the study.
• •2. Subject is currently enrolled in an investigational drug or device study.
• •3. Subject has used an investigational drug or investigational device treatment within 30 days prior to the Visit 1.
• •4. Subject has a history of prior treatment with ingenol mebutate gel.
• •5. Subject is immunosuppressed (HIV, organ transplant, systemic malignancy, etc.) in the opinion of the investigator.
• •6. Subject has a history of injury to lesions or treatment area in the past 30 days.
• •7. Subject has a history of sensitivity to any of the ingredients in the investigational product.
• •8. Subject used any topical agents (including dry powder, bland emollients, non-medicated lotions, etc.) within a 3 cm border of the area to be treated within 14 days prior to entry into the study.
• •9. Subject has used topical medications such as corticosteroids, alpha-hydroxyacids greater than 5% (e.g., glycolic acid, lactic acid, etc.), beta-hydroxyacids greater than 2% (e.g., salicylic acid), urea greater than 5%, or topical retinoids (e.g., tazarotene, adapalene, tretinoin) adjacent to or within a 3 cm border around the area to be treated within 28 days prior to entry into the study.
• •10. Subject has used cryotherapy to lesions adjacent to or within a 3 cm border around the area to be treated within 2 weeks prior to entry into the study.
• •11. Subject has used systemic steroid therapy (e.g., methylprednisolone, predinisone) or NSAIDs within 7 days from Visit 1/Day 1 or initiation during the study. \*Subjects may use Tylenol (Acetaminophen) for pain relief, as needed, throughout the study. Subjects may use low dose aspirin (81mg) for cardiac prophylaxis throughout the study.\*
• •12. Subject has used chemotherapeutic agents, immunosuppressive agents, or retinoids within 4 weeks prior to entry into the study.
• •13. Subject has applied topical treatment such as 5-FU, imiquimod, diclofenac sodium, sinecatechins ointment, or other treatments either indicated or off-label for warts to lesions adjacent to (within a 3 cm border around the Treatment Area) or within the selected Treatment Area within 90 days prior to entry into the study.
• •14. Subject has had any prior intralesional treatment of the warts including injection of candida antigen, 5-FU, and bleomycin.
• •15. Subject has any condition in the Treatment Area that would impact the treatment or proper assessment of the outcome (e.g. scarring, marked dermatitis, etc.) in the opinion of the investigator.