title: Imiquimod 5% cream is a safe and effective self-applied treatment for anogenital warts--results of an open-label, multicentre Phase IIIB trial.
abstract: Our objective was to determine the efficacy and safety of imiquimod 5% cream in the treatment of external genital/perianal warts in an open-label Phase 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 this time, patients could be re-treated for up to 16 additional weeks. Patients who experienced partial clearance during the initial treatment period entered 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%) patients (intent-to-treat (ITT) analysis) during the initial treatment period, with clearance in an additional 52 (5.5%) patients during the extended treatment period beyond 16 weeks. The overall clearance rate for the combined treatment periods was 53.3%. In a treatment failure analysis, the overall clearance rate was 65.5%; a greater proportion of female patients (75.5%) experienced 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) after 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 skin 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 weeks.
authors.affiliation: Department of Microbiology and Infectious Diseases, Royal Women's and Royal Children's Hospitals, Melbourne, Australia. garlands@cryptic.rch.unimelb.edu.au
authors.forename: S M
authors.initials: SM
authors.lastname: Garland
authors.forename: J W
authors.initials: JW
authors.lastname: Sellors
authors.forename: A
authors.initials: A
authors.lastname: Wikstrom
authors.forename: C S
authors.initials: CS
authors.lastname: Petersen
authors.forename: C
authors.initials: C
authors.lastname: Aranda
authors.forename: S
authors.initials: S
authors.lastname: Aractingi
authors.forename: R D
authors.initials: RD
authors.lastname: Maw
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000634:Aminoquinolines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000890:Anti-Infective Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003218:Condylomata Acuminata / Q000188:drug therapy*; D003257:Consumer Product Safety; D003710:Demography; D005260:Female; D005500:Follow-Up Studies; D006282:Health Personnel; D006801:Humans; D000077271:Imiquimod; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D012646:Self Administration / Q000379:methods; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014622:Vaginal Creams, Foams, and Jellies
chemical_list: D000634:Aminoquinolines; D000890:Anti-Infective Agents; D014622:Vaginal Creams, Foams, and Jellies; D000077271:Imiquimod