Imiquimod in the treatment of multifocal vulvar intraepithelial neoplasia 2/3. Results of a pilot study

J Reprod Med. 2002 Sep;47(9):701-5.


Objective: To investigate the efficacy of topical treatment with imiquimod 5% cream, an immune response modifier, in patients with vulvar intraepithelial neoplasia (VIN) 2/3.

Study design: Fifteen women (aged 35-51) with histologically proven multifocal VIN 2/3 without invasion, were entered into a prospective, observational, pilot study. Imiquimod 5% cream was applied by the patient to the vulvar lesions one to three times a week at night. Clinical response was analyzed by macroscopic examination and categorized as complete (CR) or partial (PR).

Results: Four patients achieved CR (27%) and nine patients, PR (60%) after 6-34 weeks of treatment. Two patients discontinued medication. CR was reached after 6, 7, 11 and 30 weeks of treatment.

Conclusion: This pilot study showed the potential beneficial effect of imiquimod 5% cream in multifocal VIN 2/3. In contrast to current surgical treatment, imiquimod focuses on the cause of VIN and preserves the anatomy and function of the vulva. Therefore, imiquimod may prove to be the treatment of choice in multifocal, high grade VIN.

Publication types

  • Clinical Trial

MeSH terms

  • Administration, Topical
  • Adult
  • Aminoquinolines / administration & dosage
  • Aminoquinolines / therapeutic use*
  • Antineoplastic Agents / administration & dosage
  • Antineoplastic Agents / therapeutic use*
  • Carcinoma in Situ / drug therapy*
  • Carcinoma in Situ / pathology
  • Female
  • Humans
  • Imiquimod
  • Middle Aged
  • Neoplasm Staging
  • Pilot Projects
  • Prospective Studies
  • Time Factors
  • Vaginal Creams, Foams, and Jellies
  • Vulvar Neoplasms / drug therapy*
  • Vulvar Neoplasms / pathology


  • Aminoquinolines
  • Antineoplastic Agents
  • Vaginal Creams, Foams, and Jellies
  • Imiquimod