ITIC (Imiquimod Therapy in Cervical Intraepithelial Neoplasia)-Trial

Medical University of Vienna

Status and phase: Completed; Phase 3; Phase 2

Conditions: Cervical Intraepithelial Neoplasia

Treatments: Drug: Topical imiquimod therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00941252

ITIC1.0

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Imiquimod

Active Comparator group

Description:

topical therapy for 16 weeks with imiquimod containing therapy

Treatment:

Drug: Topical imiquimod therapy

Placebo

Placebo Comparator group

Description:

topical therapy for 16 weeks with a placebo containing vaginal suppository

Treatment:

Drug: Topical imiquimod therapy