SAFETY AND EFFICACY OF 0.5-PERCENT PODOFILOX GEL IN THE TREATMENT OF ANOGENITAL WARTS

Objective: To determine the safety and efficacy of a new gel formulati on of podofilox in the treatment of anogenital warts. Design: Double-b lind, randomized, multicenter, vehicle-controlled investigation. Setti ng: Private dermatology practices, university clinics (dermatology, gy necology, and infectious diseases), and contract research organization s. 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 signifi cantly better than vehicle gel for successfully eliminating and reduci ng the number and size of anogenital warts. In the intent-to-treat pop ulation, 62 (37.1%) of 167 patients treated with 0.5% podofilox gel ha d complete clearing of the treated areas (treatment successes) compare d with 2 (2.3%) of 86 patients who had clearing of warts with the vehi cle gel (P<.001) after 4 weeks. Nineteen additional patients treated w ith 0.5% podofilox gel and 2 patients treated with vehicle gel had cle aring 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 gr oup (88.4% of the baseline number) (P=.001). The 0.5% podofilox gel wa s generally well tolerated, with predominantly mild or moderate local adverse reactions occurring in the majority of patients. Only 7 patien ts (3.2%), all receiving 0.5% podofilox gel, discontinued study treatm ent because of drug-related local reactions. Conclusions: The results demonstrated that 0.5% podofilox gel is safe and significantly more ef fective than vehicle gel in the treatment of anogenital warts.