ITIC (Imiquimod Therapy in Cervical Intraepithelial Neoplasia)-Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2011-01-31

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.

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Detailed Description

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Conditions

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Cervical Intraepithelial Neoplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Imiquimod

topical therapy for 16 weeks with imiquimod containing therapy

Group Type ACTIVE_COMPARATOR

Topical imiquimod therapy

Intervention Type 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)

Placebo

topical therapy for 16 weeks with a placebo containing vaginal suppository

Group Type PLACEBO_COMPARATOR

Topical imiquimod therapy

Intervention Type 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)

Interventions

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Topical imiquimod therapy

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)

Intervention Type DRUG

Other Intervention Names

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Aldara

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No