Topical Imiquimod in Treating Patients with Grade 2/3 Cervical Intraepithelial Neoplasia - ITIC (Imiquimod Therapy in Cervical Intraepithelial Neoplasia)-Trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-007763-16-AT

Enrollment

Registered

2009-01-26

Start date

2009-05-06

Completion date

Unknown

Last updated

2016-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Grade 2/3 Cervical Intraepithelial Neoplasia MedDRA version: 9.1 Level: LLT Classification code 10049701 Term: Cervical intraepithelial neoplasia II MedDRA version: 9.1 Level: LLT Classification code 10049702 Term: Cervical intraepithelial neoplasia III

Interventions

Trade Name: Aldara Product Name: Aldara 5% Cream Product Code: EU/1/98/080/001 Pharmaceutical Form: Suppository INN or Proposed INN: IMIQUIMOD CAS Number: 99011-02-6 Concentration unit: % percent Conc

Eligibility

Sex/Gender

All

Inclusion 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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 Participance in another clinical trial within 30 days Malignancy Immunosuppression (medication, illness) HIV- or Hepatitis infection

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of topical treatment with Imiquimod in patients with CIN 2/3.;Secondary Objective: HPV-Clearance, feasability and adverse event profile and drop-out rate;Primary end point(s): Primary endpoint: Is a topical treatment with imiquimod for 16 weeks in women with CIN 2/3 efficiant?	—

Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026