Safety and Efficacy of 0.5% Podofilox Gel in the Treatment of Anogenital Warts

OBJECTIVE To determine the safety and efficacy of a new gel formulation of podofilox in the treatment of anogenital warts. DESIGN Double-blind, randomized, multicenter, vehicle-controlled investigation. SETTING Private dermatology practices, university clinics (dermatology, gynecology, and infectious diseases), and contract research organizations. PATIENTS Three hundred twenty-six patients with anogenital warts. MAIN OUTCOME MEASURE Number of patients with clearing of all treated warts (treatment success). RESULTS The 0.5% podofilox gel was significantly better than vehicle gel for successfully eliminating and reducing the number and size of anogenital warts. In the intent-to-treat population, 62 (37.1%) of 167 patients treated with 0.5% podofilox gel had complete clearing of the treated areas (treatment successes) compared with 2 (2.3%) of 86 patients who had clearing of warts with the vehicle gel (P