Comparison Between Podofilox Topical Gel 0.5% and Allergan's Condylox® Gel 0.5% for External Anogenital Warts
Condition: External Anogenital Warts
MeSH terms: Warts; Condylomata Acuminata
Intervention: Podofilox Gel 0.5%; Condylox Topical Gel 0.5%; Placebo Gel
Intervention description: Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles; Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles; Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles
Intervention MeSH terms: Podophyllotoxin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 466.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      A clinical endpoint bioequivalence (BE) study for a Podofilox Gel 0.5% formulation for the
      treatment of external anogenital warts in comparison to Condylox® Gel 0.5% that follows the
      study design and recommendations according to Office of Generic Drugs (OGD) of U.S. Food and
      Drug Administration (FDA) Draft Guidance for Podofilox recommendations
    

Eligibility criteria:

        Inclusion Criteria:

          1. Willing and able to provide written informed consent prior to participating in this
             study.

          2. Male or female subjects, aged 18-65 inclusive, with a clinical diagnosis of external
             anogenital warts (i.e., perianal warts and/or external genital warts), including two
             or more distinct external genital warts, and wart area that is equal or less than 10
             cm2. Histological confirmation should be obtained if there is any doubt of the
             diagnosis.

          3. Females of childbearing potential may be enrolled if they practice a method of birth
             control with a reliability of at least 90%.

          4. Sexually active study participants must agree to abstain from sexual activity of any
             kind throughout the treatment period to prevent cross- and reinfection by HPV.

          5. Any female subject with childbearing potential has a negative urine pregnancy test at
             Baseline.

          6. Negative HIV test within 4 weeks before Baseline.

             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.