ITIC (Imiquimod Therapy in Cervical Intraepithelial Neoplasia)-Trial

Phase 2

Completed

• Conditions: Cervical Intraepithelial Neoplasia
• Interventions: Drug: Topical imiquimod therapy

• Registration Number: NCT00941252
• Lead Sponsor: Medical University of Vienna

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-16
• Study First Submitted QC: 2009-07-16
• Study First Posted: 2009-07-17
• Status Verified: 2011-01
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Last Update Submitted: 2011-01-21
• Last Update Posted: 2011-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Imiquimod	Topical imiquimod therapy	topical therapy for 16 weeks with imiquimod containing therapy
Placebo	Topical imiquimod therapy	topical therapy for 16 weeks with a placebo containing vaginal suppository

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of topical treatment with Imiquimod in patients with CIN 2/3	20 weeks after treatment start

Secondary Outcome Measures

Name	Time	Method
HPV-Clearance, feasibility and adverse event profile and drop-out rate	20 weeks after treatment start

Trial Locations

Locations (1)

Medical University of Vienna, Dpt. of General Gynecology and Gynecologic Oncology; 🇦🇹 Vienna, Austria