SELF-ADMINISTERED TOPICAL 5-PERCENT IMIQUIMOD CREAM FOR EXTERNAL ANOGENITAL WARTS

Objective: To compare the safety and effectiveness of 5% and 1% imiqui mod cream with vehicle cream in the treatment of external anogenital w arts. Design: Randomized, double-blind, placebo-controlled comparison that evaluated patients for total clearance of their warts. Patients w ho experienced total clearance were evaluated for recurrence in a 12-w eek follow-up. Setting: Eleven ambulatory offices, including both priv ate physician offices and referral medical centers. Patients: Three hu ndred eleven healthy men and women aged 18 years or older with 2 to 50 external anogenital warts were recruited from the practices of invest igators, referring physicians, and advertisements. Eighty-two addition al patients were screened but did not qualify. Four patients discontin ued use of the medication because of adverse effects. Interventions: F ive percent imiquimod (Aldara) cream, 1% imiquimod cream, or vehicle c ream was applied to all external warts overnight 3 times each week for 16 weeks, or until all treated warts disappeared, whichever occurred first. Main Outcome Measurements: The number of patients experiencing the elimination of all baseline warts and the recurrence rate of these warts. In addition, the reduction in baseline wart area, the duration of therapy required to eliminate warts, and the frequency and severit y of adverse reactions were principal measurements. Results: In the in tent-to-treat analysis, 54 (50%) of 109 patients who received 5% imiqu imod cream, 21 (21%) of 102 of those who received 1% imiquimod cream, and 11 (11%) of 100 patients treated with vehicle cream experienced er adication of all treated baseline warts. The difference between the ef fectiveness of 5% imiquimod cream and the vehicle cream was statistica lly significant (P<.001). Of those patients whose warts cleared during therapy, 13% of patients who received 5% imiquimod experienced a recu rrence of at least 1 wart. Recurrences occurred in none of the patient s who used 1% imiquimod cream and in 10% of patients who used the vehi cle cream. Local erythema was the most common adverse reaction, but th e majority of patients in each group experienced no or only mild local inflammatory reactions. There were no differences in incidences of fl ulike symptoms among treatment groups. Conclusions: Five percent imiqu imod cream is an effective and safe self-administered therapy for exte rnal anogenital warts when applied 3 times a week overnight for up to 16 weeks. The recurrence rate is low.