Treatment of Condyloma Acuminatum with 5% Imiquimod Cream:A Multi-centre,Randomized,Double-blind,Parallel-controlled Clinical Trial

Objective To survey the clinical therapeutic effectiveness and safeness of 5% imiquimod cream in the topical treatment of condyloma acuminatum at the perianal region and external genitalia. Methods A randomized,double blind,multi-centre,parallel-controlled clinical study was carried out.Two hundred thirty seven patients with anogenital condyloma acuminatum enrolled into the trial were randomly divided into 2 groups: the treatment group(n=119) and control group(n=118).Patients of the treatment group and control group were given each 5% imiquimod cream qs and 2.5% 5-fluorouracil cream qs,respectively,administered by topical smearing 3 times a week.The course of treatment in both groups lasted 8 weeks.Patients whose warts had been cleared up completely were followed up for 8 weeks for checking on recurrence rates. Results The cure rates were 66.4% in patients of the treatment group and 66.1% in those of the control group(P0.05);the effective rates in patients of the treatment group and control group were 86.7% and 85.6%,respectively(P0.05).6 patients in the treatment group and 27 patients in the control group experienced recurrences of warts after complete recovery,the recurrence rates being 5.0% and 22.4%,respectively(P0.05).Adverse reactions were encountered in 29 patients(24.4%) of the treatment group and 44 patients(37.3%) of the control group(P0.05).The major adverse reactions in patients of the treatment group included erythema and erosion in the topical areas where the drug was smeared.There were no systemic adverse reactions in patients of both groups. Conclusion 5% imiquimod cream was shown to be effective,safe and handy in the topical treatment of anogenital condyloma acuminatum.