Abstract: Objective To observe the clinical efficacy and safety of 5% imiquimod cream in topical treatment of anogenital warts. Methods A randomized, double-blind, parallel placebo-controlled clinical study was conducted. Patients with anogenital warts were instructed to apply the test drug topically and then clean the drug with water 6~8 hours later, three times a week for 8 weeks. Patients whose warts cleared completely were followed up for one month to determine recurrence rates. Results Two hundred and thirty-one patients with anogenital warts were enrolled in this trial. One hundred and sixteen patients were randomly selected to receive 5% imiquimod cream; and the other receive placebo cream. For 2, 4, 6, 8 weeks, the cure rates were 8.41%, 30.84%, 49.53%, 61.68%, respectively in the study group, and 2.68%, 7.14%, 16.07%, 24.11%, respectively in the control group (P<0.001); the effective rates were 34.58%, 60.75%, 68.22%, 74.77% respectively in the study group, and 10.72%, 18.75%, 28.57%, 32.14% respectively in the control group (P<0.001). Of the imiquimod-treated patients 10.61% experienced recurrences of warts in a follow-up period of one month. There was no difference of recurrent rates between the two groups. There was no systemic but topical side effects in the study group. The topical side effects mainly included mild to moderate erythema(34.55%). Conclusion 5% imiquimod cream can be used in topical treatment of anogenital warts effectively, safely and conveniently.

Key words: Condylomata acuminata, Imiquimod, Randomized controlled trials