Imiquimod 5% cream is a safe and effective self-applied treatment for anogenital warts - results of an open-label, multicentre Phase IIIB trial

Our objective was to determine the efficacy and safety of imiquimod 5% crea m in the treatment of external genital/perianal warts in an open-label Phas e IIIB trial. Patients applied imiquimod 5% cream 3 times per week, for up to 16 weeks. Those who cleared their warts were monitored during a 6-month follow-up period. If their warts recurred, or new warts developed during th is time, patients could be re-treated for up to 16 additional weeks. Patien ts who experienced partial clearance during the initial treatment period en tered an extended treatment period of up to an additional 16 weeks. A total of 943 patients from 114 clinic sites in 20 countries participated in this study. Complete clinical clearance was observed in 451/943 (47.8%) patient s (intent-to-treat (ITT) analysis) during the initial treatment period, wit h clearance in an additional 52 (5.5%) patients during the extended treatme nt period beyond 16 weeks. The overall clearance rate for the combined trea tment periods was 53.3%. In a treatment failure analysis, the overall clear ance rate was 65.5%; a greater proportion of female patients (75.5%) experi enced complete clearance than male patients (56.9%). Low recurrence rates, of 8.8% and 23.0%, were observed at the end of the 3- and 6-month follow-up periods, respectively. The sustained clearance rates (patients who cleared during treatment and remained clear at the end of the follow-up period) af ter 3 and 6 months were 41.6% and 33.0% (ITT analysis), respectively. Local erythema occurred in 67% of patients. In the majority of patients local sk in reactions were of mild to moderate severity. In conclusion, imiquimod 5% cream is an effective self-applied treatment for external genital/perianal warts when applied for up to 16 weeks and is well tolerated for up to 32 w eeks.