Safety and efficacy of 0.5% podofilox gel in the treatment of anogenital warts

Archives of Dermatology
S K TyringT Toter

Abstract

To determine the safety and efficacy of a new gel formulation of podofilox in the treatment of anogenital warts. Double-blind, randomized, multicenter, vehicle-controlled investigation. Private dermatology practices, university clinics (dermatology, gynecology, and infectious diseases), and contract research organizations. Three hundred twenty-six patients with anogenital warts. Number of patients with clearing of all treated warts (treatment success). 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 < .001) after 4 weeks. Nineteen additional patients treated with 0.5% podofilox gel and 2 patients treated with vehicle gel had clearing of warts with continued treatment up to 8 weeks. After 8 weeks, 35.9% of the baseline anogenital warts treated with 0.5% podofilox gel remained; this was significantly fewer than in the vehicle-treated group (88.4% of the baseline number) (P = .001). The 0.5...Continue Reading

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