Topical imiquimod 5% cream in external anogenital warts: a randomized, double-blind, placebo-controlled study

J Dermatol. 2004 Aug;31(8):627-31. doi: 10.1111/j.1346-8138.2004.tb00568.x.


The complete treatment of anogenital warts has not been obtained with any combination of methods; therefore, new methods are still under investigation. In this study the activity and side effects of imiquimod 5% cream were investigated. The study group consisted of 23 male and 11 female volunteers and the control group of 9 male and 2 female volunteers. Patients applied the cream three times a week, every other day in the evenings for a period of 12 weeks. After the treatment, patients were regularly monitored for six months for recurrences. At the end of the study, 23 (69.7%) patients (all of females and 54.5% of males) in the study group displayed a complete clearance, 9 patients displayed 50-90% clearance and 1 patient displayed less than 50% clearance. In the control group, only 1 patient displayed a complete clearance, 1 patient displayed 50-90% clearance, and the other 8 patients showed no alteration in the lesions. These results were statistically significantly different (p<0.01). In 15 patients in the study group, no side effects were reported; the most frequently seen side effects were erythema and erosion. In six patients that were observed for a period of six months, recurrences occurred. Imiquimod 5% cream is a topically applied medicament that should be considered as an effective and reliable medical option in the treatment of anogenital warts.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Adjuvants, Immunologic / administration & dosage*
  • Administration, Cutaneous
  • Adolescent
  • Adult
  • Aminoquinolines / administration & dosage*
  • Anus Diseases / drug therapy*
  • Anus Diseases / pathology
  • Condylomata Acuminata / drug therapy*
  • Condylomata Acuminata / pathology
  • Double-Blind Method
  • Female
  • Genital Diseases, Female / drug therapy*
  • Genital Diseases, Female / pathology
  • Genital Diseases, Male / drug therapy*
  • Genital Diseases, Male / pathology
  • Humans
  • Imiquimod
  • Male
  • Treatment Outcome


  • Adjuvants, Immunologic
  • Aminoquinolines
  • Imiquimod