A Double-blind Placebo Controlled, Randomized, Phase II Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of Twice Daily Topical Applications of AP611074 5% Gel for up to 16 Weeks in Condyloma Patients

Criterios de inclusión

• Male or female patient aged between 18 and 55 years.
• External condylomas, 2-30 lesions (no more than 2 lesions side by side); flat or papular, but not pediculated.
• Lesions must not be internal. Lesions that originate internally, but are visible externally will be considered internal and are not allowed in the study.
• Total wart area (diameter x diameter) should not be less than 10mm2 and not more than 800 mm2
• Individual wart area should not measure more than 50mm2, and the major perpendicular diameter should not measure more than 10mm (1cm).
• Lesions to be treated should have appeared between 1 to 6 months before screening, and patients should not have received any previous condyloma treatment during the last 2 months before enrollment.
• For female patients: either postmenopausal, taking adequate contraceptive method or surgically sterile.
• Patients with any history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic or infectious disease, transplanted or immunosuppressed patients or other clinical condition that, in the Investigator's judgment, prevents the patients from participating to the study.
• Patients with any clinically significant abnormality following review of screening laboratory tests, vital signs, full physical examination and ECG.
• Patients with history or presence of drug or alcohol abuse.
• Patients with positive HBs or HBc antigen or anti HCV antibody, or positive results for HIV 1 or 2 tests.
• Patients using any dermatological drug therapy in the treatment area during the last month prior the first application of the study drug.