Brief Title
ITIC (Imiquimod Therapy in Cervical Intraepithelial Neoplasia)-Trial
Official Title
Topical Imiquimod in Treating Patients With Grade 2/3 Cervical Intraepithelial Neoplasia
Brief 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.
Study Phase
Phase 2/Phase 3
Study Type
Interventional
Primary Outcome
To evaluate the efficacy of topical treatment with Imiquimod in patients with CIN 2/3
Secondary Outcome
HPV-Clearance, feasibility and adverse event profile and drop-out rate
Condition
Cervical Intraepithelial Neoplasia
Intervention
Topical imiquimod therapy
Study Arms / Comparison Groups
Imiquimod
Description: topical therapy for 16 weeks with imiquimod containing therapy
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
60
Start Date
July 2009
Completion Date
January 2011
Primary Completion Date
January 2011
Eligibility Criteria
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
Gender
Female
Ages
18 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
Paul Speiser, MD, ,
Location Countries
Austria
Location Countries
Austria
Administrative Informations
NCT ID
NCT00941252
Organization ID
ITIC1.0
Study Sponsor
Medical University of Vienna
Study Sponsor
Paul Speiser, MD, Principal Investigator, Medical University of Vienna
Verification Date
January 2011