Primary Imiquimod Treatment Versus Surgery for Vulvar Intraepithelial Neoplasia
NCT ID: NCT01861535
Last Updated: 2021-04-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
110 participants
INTERVENTIONAL
2013-06-30
2021-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Primary Imiquimod
Treatment with imiquimod will be patient self-administered for a period of 4 months with possible extension to 6 months. A thin layer of imiquimod cream should be applied to the lesion and remain overnight without a cover. Application will be once a week for 2 weeks, then twice a week the following 2 weeks and, if tolerated, 3 times a week for the last weeks. In case of severe side-effects the number of applications can be reduced; a treatment-free period of no more than 1 week is permitted
Imiquimod
Primary surgery
The type of surgery (excision or ablation) will be based on clinical findings and surgeon's judgement. After excision the specimen will be histologically analyzed to assess resection margins and rule out invasion.
Surgery
Interventions
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Imiquimod
Surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Visible, measurable lesion(s)
* Contraception (for premenopausal women)
Exclusion Criteria
* History of cancer or severe inflammatory dermatosis of the vulva
* Pregnancy, lactation
* Immunodeficiency
* Any treatment for VIN within the previous three months
* Known hypersensitivity to imiquimod
18 Years
90 Years
FEMALE
No
Sponsors
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Austrian Science Fund (FWF)
OTHER
Medical University of Graz
OTHER
Responsible Party
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Principal Investigators
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Gerda Trutnovsky, MD
Role: PRINCIPAL_INVESTIGATOR
Medical University of Graz
Karl Tamussino, MD
Role: STUDY_DIRECTOR
Medical University of Graz
Locations
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Dep. of Gynecology, Krankenhaus Barmherzige Brüder Graz
Graz, Styria, Austria
Dep. of Gynecology and Obstetrics, Landes Frauen- und Kinderklinik Linz
Linz, Upper Austria, Austria
Department of Obstetrics and Gynecology/ Medical University of Graz
Graz, , Austria
Department of Gynecology and Obstetrics, Medical University of Innsbruck
Innsbruck, , Austria
Dep. of Gynecology and Obstetrics, Klinikum Klagenfurt
Klagenfurt, , Austria
Dep. of Gynecology and Obstetrics
Leoben, , Austria
Dep. of Gynecology, Krankenhaus Barmherzige Schwestern Linz
Linz, , Austria
Dep. of Gynecology and Obstetrics, Landeskrankenhaus Salzburg
Salzburg, , Austria
Department of General Gynecology and Gynecology Oncology, Medical University of Vienna
Vienna, , Austria
Countries
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References
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Muntinga CLP, de Vos van Steenwijk PJ, Kooreman LFS, Regauer S, Abdulrahman Z, Bekkers RLM, van der Burg SH, Trutnovsky G, van Esch EMG. Pre-existing infiltration with T cells and CD14+ myeloid cells is associated with treatment response to imiquimod in primary and recurrent vulvar high-grade squamous intraepithelial lesions. J Immunother Cancer. 2025 Oct 20;13(10):e012666. doi: 10.1136/jitc-2025-012666.
Trutnovsky G, Reich O, Joura EA, Holter M, Ciresa-Konig A, Widschwendter A, Schauer C, Bogner G, Jan Z, Boandl A, Kalteis MS, Regauer S, Tamussino K. Topical imiquimod versus surgery for vulvar intraepithelial neoplasia: a multicentre, randomised, phase 3, non-inferiority trial. Lancet. 2022 May 7;399(10337):1790-1798. doi: 10.1016/S0140-6736(22)00469-X. Epub 2022 Apr 25.
Other Identifiers
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KLI293
Identifier Type: -
Identifier Source: org_study_id
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