ITIC (Imiquimod Therapy in Cervical Intraepithelial Neoplasia)-Trial - Full Text View

Sponsor:	Medical University of Vienna
Information provided by:	Medical University of Vienna
ClinicalTrials.gov Identifier:	NCT00941252

Purpose

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.

Condition	Intervention	Phase
Cervical Intraepithelial Neoplasia	Drug: Topical imiquimod therapy	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Topical Imiquimod in Treating Patients With Grade 2/3 Cervical Intraepithelial Neoplasia

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: S 26308

U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:

To evaluate the efficacy of topical treatment with Imiquimod in patients with CIN 2/3 [ Time Frame: 20 weeks after treatment start ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

HPV-Clearance, feasibility and adverse event profile and drop-out rate [ Time Frame: 20 weeks after treatment start ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	July 2009
Study Completion Date:	January 2011
Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Imiquimod topical therapy for 16 weeks with imiquimod containing therapy	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) Other Name: Aldara
Placebo Comparator: Placebo topical therapy for 16 weeks with a placebo containing vaginal suppository	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) Other Name: Aldara

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00941252

Locations

Austria
Medical University of Vienna, Dpt. of General Gynecology and Gynecologic Oncology
Vienna, Austria, 1090

Sponsors and Collaborators

Medical University of Vienna

Investigators

Principal Investigator:

Paul Speiser, MD

Medical University of Vienna

More Information

No publications provided

Responsible Party:	Prof. MD. Paul Speiser, Medical University of Vienna
ClinicalTrials.gov Identifier:	NCT00941252 History of Changes
Other Study ID Numbers:	ITIC1.0
Study First Received:	July 16, 2009
Last Updated:	January 21, 2011
Health Authority:	Austria: Austrian Agency for Health and Food Safety

Additional relevant MeSH terms:

Neoplasms
Cervical Intraepithelial Neoplasia
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Imiquimod

Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Interferon Inducers

ClinicalTrials.gov processed this record on February 09, 2012