doubleblind randomized clinical trial of selfadministered podofilox solution versus vehicle in the treatment of genital warts purpose genital warts are a highly prevalent and chronic sexually transmitted disease for which there is no completely satisfactory therapy conventional ablative therapy requires repeated treatment often for months or years this study was undertaken to evaluate the safety and efficacy of 05 podofilox in patientadministered treatment of penile wartspatients and methods thirtyeight men with penile warts were randomly assigned to doubleblind selfadministration of 05 podofilox solution or placebo twice daily for 3 days per week for 4 weeks eleven podofilox and 15 placebo recipients with residual warts then received an additional 4 weeks of openlabel treatmentresults by the end of treatment podofilox recipients had their mean wart number and area reduced to 159 and 51 of baseline values compared to 974 and 929 in the placebo group p 00001 local adverse reactions were more common in the podofilox group but were transient complete disappearance of warts was observed in 25 533 of 45 treatment courses including openlabel treatment recurrences of warts after therapy were frequent only 21 of patients remained free of warts 2 weeks after completing treatment and subsequent recurrences were noted in all patients available for longterm followup which is a common limitation of ablative therapy for genital wartsconclusion podofilox 05 solution is effective in treating penile warts and is well tolerated in a selfadministered regimen podofilox 05 offers potential advantages in safety and cost over podophyllin resin therapy of genital warts