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Safety and Efficacy of 0.5% Podofilox Gel in the Treatment of Anogenital Warts
Stephen Tyring, MD, PhD;
Libby Edwards, MD;
Lisa K. Cherry, RN;
William M. Ramsdell, MD;
Steven Kotner, MD;
Mitchell D. Greenberg, MD;
J. Corwin Vance, MD;
Gail Barnum, ARNP;
Sydney H. Dromgoole, PhD;
Frank P. Killey, PhD;
Tanya Toter
Arch Dermatol. 1998;134:33-38.
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<.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% podofilox gel was generally well tolerated, with predominantly mild or moderate local adverse reactions occurring in the majority of patients. Only 7 patients (3.2%), all receiving 0.5% podofilox gel, discontinued study treatment because of drug-related local reactions.
Conclusions The results demonstrated that 0.5% podofilox gel is safe and significantly more effective than vehicle gel in the treatment of anogenital warts.
From the Departments of Dermatology and Microbiology and Immunology, University of Texas Medical Branch, Galveston, and the Center for Clinical Studies, Nassau Bay, Tex (Dr Tyring); the Department of Dermatology, Carolinas Medical Center, Charlotte, NC (Dr Edwards); Brown University, Providence, RI (Ms Cherry); VRG International, San Diego, Calif (Dr Kotner); the Department of Obstetrics and Gynecology, The Graduate Hospital, Philadelphia, Pa (Dr Greenberg); the Department of Dermatology, Hennepin Medical Center, Minneapolis, Minn (Dr Vance); the Department of Internal Medicine, University of Washington, Seattle (Ms Barnum); and Oclassen Pharmaceuticals Inc, San Rafael, Calif (Drs Dromgoole and Killey and Ms Toter). Dr Kotner is now in private practice in South Pittsburgh, Tenn. Dr Ramsdell is in private practice in Austin, Tex.
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