Clinical trial · Interventional
Imiquimod Treatment of Residual or Recurrent CIN Lesions: a Study Protocol
A Randomized, Single Blinded Trial to Evaluate the Efficacy of Imiquimod in Women With Residual/Recurrent Cervical Intraepithelial Neoplasia (CIN) After Previous Treatment
NCT02669459CI-TRIAL-00031549TopIC-2unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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 purpose of this study is to investigate if imiquimod can be used as a non-invasive option in the treatment of residual/recurrent CIN lesions.
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 |
|---|---|---|---|
| Imiquimod | Drug | Imiquimod | ALIAS |
| LLETZ | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- LLETZ
- description
- LLETZ (Large Loop excision of the transformation zone) treatment conform current guidelines, which is also the current gold standard in the Netherlands
- interventionNames
- Procedure: LLETZ
- type
- OTHER
- label
- Imiquimod 5% cream
- description
- intervention group
- interventionNames
- Drug: Imiquimod
Primary outcomes (1)
- measure
- Reduction to normal cytology
- timeFrame
- 6 months after treatment
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven CIN 2 or CIN 3, without invasion after previous surgical treatment at least 6 months before diagnosis. * Histologically proven recurrent CIN 1 after previous surgical treatment at least 6 months before diagnosis. Persistent CIN 1 is defined as CIN 1 at least persistent for 6 months and proven with histology. * The patient is willing to use a medically acceptable method of contraception throughout the study * Women older than 18 years of age. Exclusion Criteria: * Pregnancy or lactation * (Micro-)invasive carcinoma * Past history of cervical cancer * Hypersensitivity of any components of the formulation * History of psoriasis or other inflammatory dermatosis of the vulva * Immunodeficiency or treatment with immunosuppressive medication * Insufficient understanding of the Dutch or English language
References
Publications (24)
- RESULTFerlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9. PMID 25220842
- RESULTWright TC Jr, Gagnon S, Richart RM, Ferenczy A. Treatment of cervical intraepithelial neoplasia using the loop electrosurgical excision procedure. Obstet Gynecol. 1992 Feb;79(2):173-8. PMID 1731281
- RESULTMartin-Hirsch PL, Paraskevaidis E, Kitchener H. Surgery for cervical intraepithelial neoplasia. Cochrane Database Syst Rev. 2000;(2):CD001318. doi: 10.1002/14651858.CD001318. PMID 10796771
- RESULTLuesley DM, McCrum A, Terry PB, Wade-Evans T, Nicholson HO, Mylotte MJ, Emens JM, Jordan JA. Complications of cone biopsy related to the dimensions of the cone and the influence of prior colposcopic assessment. Br J Obstet Gynaecol. 1985 Feb;92(2):158-64. doi: 10.1111/j.1471-0528.1985.tb01068.x. PMID 3970895
- RESULTSadek AL. Needle excision of the transformation zone: A new method for treatment of cervical intraepithelial neoplasia. Am J Obstet Gynecol. 2000 Apr;182(4):866-71. doi: 10.1016/s0002-9378(00)70337-1. PMID 10764464
- RESULTConner SN, Cahill AG, Tuuli MG, Stamilio DM, Odibo AO, Roehl KA, Macones GA. Interval from loop electrosurgical excision procedure to pregnancy and pregnancy outcomes. Obstet Gynecol. 2013 Dec;122(6):1154-9. doi: 10.1097/01.AOG.0000435454.31850.79. PMID 24201682
- RESULTJin G, LanLan Z, Li C, Dan Z. Pregnancy outcome following loop electrosurgical excision procedure (LEEP) a systematic review and meta-analysis. Arch Gynecol Obstet. 2014 Jan;289(1):85-99. doi: 10.1007/s00404-013-2955-0. Epub 2013 Jul 11.