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Department of Dermatology and Venereology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100730, China

Objective To observe the clinical efficacy and safety of 5% imiquimod cream in topical treatment of condyloma acuminatum and to compare it with 2.5% fluorouracil(5-FU) cream. Methods A randomized, double-blind, parallel group, multi-center clinical study was conducted. The patients in the study and control groups topically used 5% imiquimod cream and 2.5% 5-FU cream, respectively, 3 times per week for 8 weeks. Two-hundred and forty-four patients with condyloma acuminatum were enrolled into this trial. Of them, 125 received 5% imiquimod cream treatment and 119 used 2.5% 5-FU cream. Results The results showed that in the study group, the cure rates were 52.00%, 74.40%, 81.60% and 92.80% and the response rates were 79.20%, 93.60%, 97.60% and 97.60% for the 2-, 4-, 6- and 8- week treatment, respectively. In the 5-FU group, the cure rates were 52.10%, 70.59%, 78.15% and 89.92%, and the response rates were 84.03%, 94.12%, 94.96% and 97.48% for the 2-, 4-, 6- and 8- week treatment, respectively. There was no statistical difference between the two groups (P>0.05). The side effects were mainly local reactions, including erythema, pain, erosion, itching, etc. No systemic side effect was found. Conclusion 5% imiquimod cream is effective, convenient and safe in the treatment of condyloma acuminatum.