ITIC (Imiquimod Therapy in Cervical Intraepithelial Neoplasia)-Trial
Information source: Medical University of Vienna
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cervical Intraepithelial Neoplasia
Intervention: Topical imiquimod therapy (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: Medical University of Vienna Official(s) and/or principal investigator(s): Paul Speiser, MD, Principal Investigator, Affiliation: Medical University of Vienna
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.
Clinical Details
Official title: Topical Imiquimod in Treating Patients With Grade 2/3 Cervical Intraepithelial Neoplasia
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: To evaluate the efficacy of topical treatment with Imiquimod in patients with CIN 2/3
Secondary outcome: HPV-Clearance, feasibility and adverse event profile and drop-out rate
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Medical University of Vienna, Dpt. of General Gynecology and Gynecologic Oncology, Vienna 1090, Austria
Additional Information
Starting date: July 2009
Last updated: January 21, 2011
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