ITIC (Imiquimod Therapy in Cervical Intraepithelial Neoplasia)-Trial

Cervical Intraepithelial Neoplasia Clinical Trial

— ITIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00941252
• Other study ID #: ITIC1.0
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 16, 2009
• Last updated: January 21, 2011
• Start date: July 2009
• Est. completion date: January 2011

Study information

• Verified date: January 2011
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Austrian Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Intraepithelial Neoplasia
• Neoplasms

Intervention

Drug:
• 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)

Locations

Country	Name	City	State
Austria	Medical University of Vienna, Dpt. of General Gynecology and Gynecologic Oncology	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the efficacy of topical treatment with Imiquimod in patients with CIN 2/3		20 weeks after treatment start	No
Secondary	HPV-Clearance, feasibility and adverse event profile and drop-out rate		20 weeks after treatment start	Yes