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Completed

NCT Number: NCT00941252

ITIC (Imiquimod Therapy in Cervical Intraepithelial Neoplasia)-Trial

The present primary therapy of cervical intraepithelial neoplasia (CIN) grade 3 and persistent CIN 2 represents conisation. Surgical treatment can cause perioperative (infection, bleeding in in 5-10%) and postoperative (increased risk of preterm labor) complications, as well as incomplete resections (20%) and risk of recurrence in 5-17%. Imiquimod is an immunomodulating drug, that has been reported to be effective in human papilloma virus-related disease, such as vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VAIN), and anal intraepithelial neoplasia (AIN). The present randomised, placebo controlled, double blind study evaluates the efficacy of a topical treatment with imiquimod for 16 weeks in 60 patients with histologically confirmed CIN 2/3.

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Key information

Conditions

Cervical Intraepithelial Neoplasia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Neoplasms Precancerous Conditions Urogenital Diseases Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Medical University of Vienna, Dpt. of General Gynecology and Gynecologic Oncology

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Caucasian women aged 18 years and older with proven HPV-associated CIN 2/3
  • Colposcopy with fully visible transformation zone and lesion
  • Safe Contraception
  • Signed Informed Consent
  • Negative urine pregnancy test
  • Able to communicate well with the investigator, to understand and comply with the requirements of the study
  • Signed the written informed consent

Exclusion criteria

  • Women who are pregnant or lactating or become pregnant during the conduct of the study
  • Symptoms of a clinically relevant illness in the 3 weeks before the first study day
  • History of hypersensitivity to the trial drug or to drugs with a similar chemical structure
  • Participating in another clinical trial within 30 days
  • Malignancy
  • Immunosuppression (medication, illness)
  • HIV- or Hepatitis infection

Treatment and study plan

Topical imiquimod therapy

Drug

therapy consists of treatment with topical vaginal suppositories for 16 weeks, each vaginal suppository contains 6.25mg of imiquimod, frequency (one time a week in treatment week 1+2, two times a week in treatment week 3+4, three times a week in treatment week 5-16)

Other names: Aldara

Primary outcomes

  1. To evaluate the efficacy of topical treatment with Imiquimod in patients with CIN 2/3

    Time frame: 20 weeks after treatment start

Secondary outcomes

  1. HPV-Clearance, feasibility and adverse event profile and drop-out rate

    Time frame: 20 weeks after treatment start

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Topical Imiquimod in Treating Patients With Grade 2/3 Cervical Intraepithelial Neoplasia

Acronym: ITIC

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jul 17, 2009
Registry last updated
Jan 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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