ITIC (Imiquimod Therapy in Cervical Intraepithelial Neoplasia)-Trial (ITIC)
January 21, 2011 updated by: Medical University of Vienna
Topical Imiquimod in Treating Patients With Grade 2/3 Cervical Intraepithelial Neoplasia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Vienna, Austria, 1090
- Medical University of Vienna, Dpt. of General Gynecology and Gynecologic Oncology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Imiquimod
topical therapy for 16 weeks with imiquimod containing therapy
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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:
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Placebo Comparator: Placebo
topical therapy for 16 weeks with a placebo containing vaginal suppository
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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To evaluate the efficacy of topical treatment with Imiquimod in patients with CIN 2/3
Time Frame: 20 weeks after treatment start
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20 weeks after treatment start
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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HPV-Clearance, feasibility and adverse event profile and drop-out rate
Time Frame: 20 weeks after treatment start
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20 weeks after treatment start
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Paul Speiser, MD, Medical University of Vienna
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2009
Primary Completion (Actual)
January 1, 2011
Study Completion (Actual)
January 1, 2011
Study Registration Dates
First Submitted
July 16, 2009
First Submitted That Met QC Criteria
July 16, 2009
First Posted (Estimate)
July 17, 2009
Study Record Updates
Last Update Posted (Estimate)
January 24, 2011
Last Update Submitted That Met QC Criteria
January 21, 2011
Last Verified
January 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ITIC1.0
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.