Clinical trial · Interventional
Topical Imiquimod Versus Conization to Treat Cervical Intraepithelial Neoplasia
ITIC2 Trial - Topical Imiquimod Versus Conization to Treat Cervical Intraepithelial Neoplasia: Randomised Controlled, Non-inferiority Trial
NCT01283763CI-TRIAL-00024543ITIC2terminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): poor recruitment
Summary
Brief summary (as posted)
The purpose of this study is to investigate the non-inferiority of a topical Imiquimod therapy in patients with persistent CIN 2/3 when compared to standard therapy, i.e. conization A randomized, controlled, non-inferiority AGO-Austria trial
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conization | Procedure | — | UNRESOLVED |
| Topical Imiquimod | Drug | Imiquimod | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Topical Imiquimod
- description
- 16 weeks topical Imiquimod
- interventionNames
- Drug: Topical Imiquimod
- type
- ACTIVE_COMPARATOR
- label
- Conization
- description
- Large loop excision of the transformation zone
- interventionNames
- Procedure: Conization
Primary outcomes (1)
- measure
- HPV clearance
- timeFrame
- 6 months after treatment completion
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: 1. Women aged ≥18 years diagnosed with histologically verified CIN 3 and women aged ≥ 30 years diagnosed with CIN 2 2. Satisfactory colposcopy 3. Signed informed consent 4. Negative pregnancy test 5. Appropriate contraception method for fertile women during active study period 6. Adequate compliance Exclusion criteria: 1. Adenocarcinoma in situ 2. History of previous conization 3. Malignant disease at the time of inclusion 4. Colposcopy suspicious for invasive disease 5. Pregnancy and lactation period 6. Known allergy or intolerance to IMQ 7. Contraindications to conization or IMQ 8. Symptoms of a clinically relevant disease 9. Known HIV infection 10. Evidence of a clinically significant immunodeficiency 11. Current, reported participation in another experimental, interventional protocol
References
Publications (1)
- DERIVEDPolterauer S, Reich O, Widschwendter A, Hadjari L, Bogner G, Reinthaller A, Joura E, Trutnovsky G, Ciresa-Koenig A, Ganhoer-Schimboeck J, Boehm I, Berger R, Langthaler E, Aberle SW, Heinze G, Gleiss A, Grimm C. Topical imiquimod compared with conization to treat cervical high-grade squamous intraepithelial lesions: Multicenter, randomized controlled trial. Gynecol Oncol. 2022 Apr;165(1):23-29. doi: 10.1016/j.ygyno.2022.01.033. Epub 2022 Feb 15. PMID 35177279