Comparison Between Podofilox Topical Gel 0.5% and Allergan's Condylox® Gel 0.5% for External Anogenital Warts

Exclusion Criteria

• •7. Female subjects who are pregnant or lactating or planning to become pregnant during the study period.
• •8. Hypersensitivity or intolerance to Podofilox or any component of the formulation.
• •9. History of previous unsuccessful treatment with any formulation of Podofilox.
• •10. Wart area that is greater than 10 cm2.
• •11. Patients with internal anogenital and mucous membrane warts, Bowenoid papulosis, squamous cell carcinoma, active herpes lesion, or other skin abnormalities of treatment area, such as eczema, or skin that had not healed following surgery (cryosurgery, laser ablation or similar).
• •12. Primary or secondary immunodeficiency.
• •13. Known presence of diabetes type I or II.
• •14. Local irritation in any treatment area that would interfere with treatment.
• •15. Use within 4 weeks prior to baseline of any: 1) treatment for anogenital warts, 2) systemic corticosteroids, or 3) systemic immunosuppressive drug.
• •16. Any medical or surgical condition in the judgment of the Investigator that may interfere with the assessment of efficacy or safety, or pose a risk to the subject.
• •17. Patients known to abuse alcohol and/or drugs, or with a history of chronic alcohol or drug abuse that may result in protocol noncompliance.
• •18. Received another investigational drug, device or biologic within 90 days prior to the start of Screening or has planned to participate in another clinical trial while enrolled in this study.
• •19. Subjects who in the opinion of the investigator, are unlikely to be able to follow the restrictions of the protocol and complete the study
• •20. Employee (or employee's family member) of the research center or private practice, CRO or Sponsor, or subjects who have a conflict of interest.
• •21. Subjects living (e.g., siblings, spouses, relatives, roommates) in the same household cannot be enrolled in the study at the same time.
• •22. Previous enrollment in this study, current enrollment in this study at another participating site or current enrollment in another study (in parallel to this study) at another clinical research site.