An open-label phase II pilot study investigating the optimal duration of imiquimod 5% cream for the treatment of external genital warts in women

Int J STD AIDS. 2006 Jul;17(7):448-52. doi: 10.1258/095646206777689161.


Our objective was to determine the optimal duration of treatment with imiquimod for external genital warts over 4, 8, 12 or 16 weeks. A total of 120 women with a history of genital warts for a median of 3-6 months and prior alternative treatments in 73% were evaluated for total clearance rates. There was no statistically significant difference in complete clearance rates after 16-week follow-up across treatment groups: four weeks (40.0%), eight weeks (48.4%), 12 weeks (39.3%) and 16 weeks (51.6%). Imiquimod was well tolerated, and in those treated for four weeks there was a lower incidence of local skin reactions such as erythema and erosion, and no incidences of pain. These preliminary results suggest that a four-week treatment course of imiquimod applied thrice weekly for women with external genital warts may provide a reasonable approach with comparable efficacy and compliance, and minimal adverse events, drug costs and clinic visits.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Administration, Topical
  • Adolescent
  • Adult
  • Aminoquinolines / administration & dosage*
  • Aminoquinolines / adverse effects
  • Aminoquinolines / therapeutic use
  • Condylomata Acuminata / drug therapy*
  • Female
  • Genital Diseases, Female / drug therapy*
  • Humans
  • Imiquimod
  • Interferon Inducers / administration & dosage*
  • Interferon Inducers / adverse effects
  • Interferon Inducers / therapeutic use
  • Middle Aged
  • Time Factors
  • Treatment Outcome


  • Aminoquinolines
  • Interferon Inducers
  • Imiquimod