Randomized clinical trial of imiquimod: an adjunct to treating cervical dysplasia

Am J Obstet Gynecol. 2012 Jan;206(1):42.e1-7. doi: 10.1016/j.ajog.2011.06.105. Epub 2011 Jul 13.

Abstract

Objectives: Human papillomavirus (HPV) infection is a major risk factor for cervical cancer. Imiquimod is a topical medication that enhances the immune response to HPV-induced genital warts. This study evaluated cervical application of imiquimod as an adjunct to standard treatment for cervical dysplasia.

Study design: Fifty-six patients were randomized to standard excisional/ablative treatment vs applications of imiquimod followed by standard treatment. The primary endpoint was dysplasia recurrence within 2 years.

Results: There were no differences in dysplasia recurrence between the 2 groups. Treatment was well tolerated, with side effects being mild but significantly worse in women receiving imiquimod for, chills, fatigue, fever, headache, myalgias, and vaginal discharge.

Conclusion: This trial does not support the hypothesis that imiquimod, as used in this trial, has an impact on recurrence of cervical dysplasia, but the adequacy of findings are limited by sample size. The trial does support the feasibility and acceptability of the use of imiquimod on the cervix.

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adult
  • Aminoquinolines / adverse effects
  • Aminoquinolines / therapeutic use*
  • Antineoplastic Agents / adverse effects
  • Antineoplastic Agents / therapeutic use*
  • Antiviral Agents / adverse effects
  • Antiviral Agents / therapeutic use
  • Condylomata Acuminata / drug therapy
  • Condylomata Acuminata / virology
  • Drug Administration Routes
  • Female
  • Humans
  • Imiquimod
  • Papillomavirus Infections / drug therapy
  • Papillomavirus Infections / surgery
  • Severity of Illness Index
  • Treatment Outcome
  • Uterine Cervical Dysplasia / drug therapy*
  • Uterine Cervical Dysplasia / surgery
  • Uterine Cervical Dysplasia / virology
  • Uterine Cervical Neoplasms / drug therapy*
  • Uterine Cervical Neoplasms / surgery
  • Uterine Cervical Neoplasms / virology
  • Young Adult

Substances

  • Aminoquinolines
  • Antineoplastic Agents
  • Antiviral Agents
  • Imiquimod