Topical imiquimod can reverse vulvar intraepithelial neoplasia: a randomised, double-blinded study

Gynecol Oncol. 2007 Nov;107(2):219-22. doi: 10.1016/j.ygyno.2007.06.003. Epub 2007 Jul 25.


Objective: To investigate the effect of topical imiquimod in patients with vulvar intraepithelial neoplasia (VIN).

Methods: We used a prospective, randomised, double-blinded, placebo-controlled study. Women with biopsy verified, visible VIN2 or VIN3, in a biopsy not older than 2 months were considered.

Results: Thirty-two patients were included, one was excluded before treatment. Twenty-one received active treatment, 10 received placebo. Seventeen (81%) in the treatment group showed complete response, two (10%) partial response and none responded in the placebo-group when evaluated by a biopsy 2 months after a treatment period of 16 weeks. Fourteen of 21 patients (67%) in the treatment group had to reduce the number of applications due to local side-effects.

Conclusion: The topical treatment with imiquimod 5% was shown in this setting to be very efficient. Local side effects were a common feature, but tolerable after dose reduction. Long-term results are not known, but a planned cohort study of this population will show the rate of recurrences.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adjuvants, Immunologic / administration & dosage*
  • Adjuvants, Immunologic / adverse effects
  • Administration, Topical
  • Adult
  • Aged
  • Aminoquinolines / administration & dosage*
  • Aminoquinolines / adverse effects
  • Antineoplastic Agents / administration & dosage*
  • Antineoplastic Agents / adverse effects
  • Carcinoma in Situ / drug therapy*
  • Double-Blind Method
  • Female
  • Humans
  • Imiquimod
  • Middle Aged
  • Pain / chemically induced
  • Prospective Studies
  • Treatment Outcome
  • Vulvar Neoplasms / drug therapy*


  • Adjuvants, Immunologic
  • Aminoquinolines
  • Antineoplastic Agents
  • Imiquimod