Treatment of Condyloma Acuminatum with Imiquimod Cream:A Randomized, Double-blind, Place-bo-controlled, Multi-central Clinical Trial

Objective To observe the clinical efficacy and safety of 5% imiquimod cream in the topical treatment of condyloma acuminatum(CA). Methods A randomized,double-blind,parallel placebo-controlled clinical study was conducted.The test drug was topically used in CA patients,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 fifty-eight patients with anogenital warts were enrolled into this trial.One hundred twenty-nine patients were randomly selected to receive 5% imiquimod cream;129 patients were randomly chosen to receive placebo cream.Results showed that the cure rates were 12.30%,32.79%,50%,60.66% respectively in study group for 2,4,6,8 weeks and were 4.88%,14.63%,19.51%,26.02% respectively in control group for 2,4,6,8 weeks(P<0.001).The response rates were 36.89%,59.84%,68.03%,70.49% respectively in study group for 2,4,6,8 weeks and13.82%,26.83%,32.52%,32.52% respectively in control group for 2,4,6,8 weeks(P<0.001).Of imiquimod-treated patients whose warts cleared completely and who finished one month follow-up period,5.41%(4 of 74)experienced recurrences of warts.Side effect included erythema(60.94%),edema(31.26%),erosion(42.96%),ulceration(4.68%),burning(20.32%),pain(36.72%),itching(17.18%).There was no systemic side effect in two groups. Conclusion 5% Imiquimod cream in the topical treatment of anogenital warts is effective,safe and convenient. Key words: Condylomata acuminata; Administration,cutaneous; Imiquimod