ITIC (Imiquimod Therapy in Cervical Intraepithelial Neoplasia)-Trial

Study Overview
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Brief Summary
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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.

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

Conditions
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Cervical Intraepithelial Neoplasia

Intervention / Treatment
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* Drug: Topical imiquimod therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Imiquimod<br>topical therapy for 16 weeks with imiquimod containing therapy | Drug: Topical imiquimod therapy<br>* 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)<br>* Other names: Aldara;|
| Placebo Comparator: Placebo<br>topical therapy for 16 weeks with a placebo containing vaginal suppository | Drug: Topical imiquimod therapy<br>* 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)<br>* Other names: Aldara;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy of topical treatment with Imiquimod in patients with CIN 2/3 |  | 20 weeks after treatment start | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HPV-Clearance, feasibility and adverse event profile and drop-out rate |  | 20 weeks after treatment start |