Clinical trial · Interventional
ITIC (Imiquimod Therapy in Cervical Intraepithelial Neoplasia)-Trial
Topical Imiquimod in Treating Patients With Grade 2/3 Cervical Intraepithelial Neoplasia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Intraepithelial Neoplasia | Cervical Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Topical imiquimod therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Imiquimod
- description
- topical therapy for 16 weeks with imiquimod containing therapy
- interventionNames
- Drug: Topical imiquimod therapy
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- topical therapy for 16 weeks with a placebo containing vaginal suppository
- interventionNames
- Drug: Topical imiquimod therapy
Primary outcomes (1)
- measure
- To evaluate the efficacy of topical treatment with Imiquimod in patients with CIN 2/3
- timeFrame
- 20 weeks after treatment start
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDGrimm 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. PMID 22914404