The purpose of this study was to determine the efficacy and safety of 0.5% podofilox solution (Condylox) for the treatment of genital warts in women. Thirty-seven women with anogenital warts applied the solution to the surface of these warts twice daily for 3 days, followed by 4 drug-free days. A minimum of two and a maximum of four treatment cycles were given. The subjects were evaluated weekly for the first 4 weeks and again at 6 and 10 weeks. At the end of 10 weeks, the mean number of warts per patient was reduced from 6.27 to 1.1, and half of the patients were completely cleared of warts. Only eight of 37 subjects (21.6%) developed new warts during the study period. Approximately 15% of patients reported "severe" local reactions to the treatment after the first treatment cycle, but this was reduced to only 5% by the last treatment cycle. During the same period, the patients reporting no side effects increased from 44 to 86%. The only woman who discontinued the study did so because of dizziness and epigastric discomfort, probably unrelated to drug use. Thus, 0.5% podofilox solution appears to be an effective treatment for condylomata acuminata, with acceptable side effects that are local and temporary.
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