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ITIC (Imiquimod Therapy in Cervical Intraepithelial Neoplasia)-Trial

This study has been completed.
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00941252
First received: July 16, 2009
Last updated: January 21, 2011
Last verified: January 2011
History of Changes

July 16, 2009
January 21, 2011
July 2009
January 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00941252 on ClinicalTrials.gov Archive Site
HPV-Clearance, feasibility and adverse event profile and drop-out rate [ Time Frame: 20 weeks after treatment start ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
ITIC (Imiquimod Therapy in Cervical Intraepithelial Neoplasia)-Trial
Topical Imiquimod in Treating Patients With Grade 2/3 Cervical Intraepithelial Neoplasia

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.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Cervical Intraepithelial Neoplasia
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
  • Active Comparator: Imiquimod
    topical therapy for 16 weeks with imiquimod containing therapy
    Intervention: Drug: Topical imiquimod therapy
  • Placebo Comparator: Placebo
    topical therapy for 16 weeks with a placebo containing vaginal suppository
    Intervention: Drug: Topical imiquimod therapy
Grimm C, Polterauer S, Natter C, Rahhal J, Hefler L, Tempfer CB, Heinze G, Stary G, Reinthaller A, Speiser P. Treatment of cervical intraepithelial neoplasia with topical imiquimod: a randomized controlled trial. Obstet Gynecol. 2012 Jul;120(1):152-9. doi: 10.1097/AOG.0b013e31825bc6e8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
January 2011
January 2011   (final data collection date for primary outcome measure)

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
Female
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT00941252
ITIC1.0
Yes
Prof. MD. Paul Speiser, Medical University of Vienna
Medical University of Vienna
Not Provided
Principal Investigator: Paul Speiser, MD Medical University of Vienna
Medical University of Vienna
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP