A Study of A-101 Topical Solution for the Treatment of Common Warts

Exclusion Criteria

• •1. Subject has clinically atypical common warts.
• •2. Subject is immunocompromised (e.g., due to chemotherapy, systemic steroids, genetic immunodeficiency, transplant status, etc.).
• •3. Subject has a history of Human Immunodeficiency Virus (HIV) infection.
• •4. Subject has had any Human Papilloma Virus (HPV) vaccine within 6 months prior to Visit 1.
• •5. Subject has used any of the following intralesional therapies within the specified period prior to Visit 2:
• •1. Immunotherapy (e.g., Candida antigen, mumps antigen, Trichophyton antigen); 8 weeks
• •2. Anti-metabolite therapy (e.g., bleomycin, 5-fluorouracil); 8 weeks
• •6. Subject has used any of the following systemic therapies within the specified period prior to Visit 2:
• •1. Immunomodulatory/immunosuppressant therapy (e.g., etanercept, alefacept, infliximab); 16 weeks
• •2. Glucocorticosteroids (inhaled and intra-nasal steroids are permitted); 28 days
• •7. Subject has used any of the following topical therapies within the specified period prior to Visit 2 on, or in the proximity to any of the common warts identified for treatment, that in the investigator's opinion interferes with the study medication treatment or the study assessments:
• •1. LASER, light or other energy-based therapy (e.g., intense pulsed light \[IPL\], photodynamic therapy \[PDT\]); 180 days
• •2. Immunotherapy (e.g., imiquimod, squaric acid dibutyl ester\[SADBE\], etc.) 12 weeks
• •3. Liquid nitrogen, electrodesiccation, curettage; 60 days
• •4. Hydrogen peroxide; 90 days
• •5. Antimetabolite therapy (e.g., 5-fluorouracil); 8 weeks
• •6. Retinoids; 90 days
• •7. Over-the-counter (OTC) wart therapies and cantharidin; 28 days
• •8. Subject currently has or has had any of the following within the specified period prior to Visit 1 on or in the proximity to any of the common warts identified for treatment that, in the investigator's opinion, interferes with the study medication treatment or the study assessments:
• •1. Cutaneous malignancy; 180 days
• •2. Sunburn; currently
• •3. Pre-malignancy (e.g., actinic keratosis); currently
• •9. Subject has a history of sensitivity to any of the ingredients in the study medications.
• •10. Subject has any current skin or systemic disease (e.g., psoriasis, atopic dermatitis, eczema, sun damage), or condition (e.g., sunburn, excessive hair, open wounds) that, in the opinion of the investigator, might put the subject at undue risk by study participation or interfere with the study conduct or evaluations.
• •11. Participation in another therapeutic investigational drug/device trial in which administration of an investigational treatment occurred with 30 days prior to Visit 1.
• •12. Subject has an active malignancy.
• •13. Subjects is viewed by the Principal Investigator as not being able to complete the study.