NCT01861535|CompletedPhase 3DMC
Primary Imiquimod Treatment Versus Surgery for Vulvar Intraepithelial Neoplasia
PITVIN
Loading search results
Sponsor study identifier
interventional
110
1 country
9
Study Start
June 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2021
Actual (reported)Study Completion
February 2021
Actual (reported)To evaluate the efficacy (defined as complete clinical response at 6 months) of imiquimod vs. standard treatment (surgery) for vulvar intraepithelial neoplasia (VIN).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 6, 2013
Actual (reported)May 23, 2013
Actual (reported)June 2013
Date type not reportedThis date has not been verified as actual or estimated.
February 2021
Actual (reported)February 2021
Actual (reported)Complete clinical response
No clinical evidence of vulvar lesion, i.e. 100% reduction of primary lesion size
6 months
Clinical response/ lesion size
6 months
Histologic response
6 months
Extent of surgery
6 months
HPV status
6 months
Clinical response/lesion size
12 months
"Cervical Dysplasia Distress" Questionnaire
6 months
"Cervical Dysplasia Distress" questionnaire
12 months
"Fear of Progression" Questionnaire
6 months
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
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.
Dep. of Gynecology, Krankenhaus Barmherzige Brüder Graz
Graz, Styria, 8020, Austria
Dep. of Gynecology and Obstetrics, Landes Frauen- und Kinderklinik Linz
Linz, Upper Austria, 4020, Austria
Department of Obstetrics and Gynecology/ Medical University of Graz
Graz, 8036, Austria
Department of Gynecology and Obstetrics, Medical University of Innsbruck
Innsbruck, 6020, Austria
Dep. of Gynecology and Obstetrics, Klinikum Klagenfurt
Klagenfurt, Austria
Dep. of Gynecology and Obstetrics
Leoben, Austria
Dep. of Gynecology, Krankenhaus Barmherzige Schwestern Linz
Trutnovsky G, Muntinga C, Holter M, Pucher D, Bracic T, Huetter C, Ciresa-Konig A, Polterauer S, Tamussino K, van Esch E. Risk factors for recurrence of vulvar high-grade squamous intra-epithelial lesions: long-term follow-up of the PITVIN Study (primary imiquimod vs surgery for vulvar intra-epithelial neoplasia). Int J Gynecol Cancer. 2026 Apr;36(4):104560. doi: 10.1016/j.ijgc.2026.104560. Epub 2026 Feb 11.
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.
Gerda Trutnovsky, MD
Medical University of Graz
Karl Tamussino, MD
Medical University of Graz
110 participants (actual enrollment reported by the registry).
First Submitted
May 6, 2013
First Posted
May 23, 2013
Study Start
June 2013
Date type not reportedThis date has not been verified as actual or estimated.
A Study to Evaluate Effectiveness of Imiquimod 5% Cream in Superficial Basal Cell Carcinoma
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Linz, 4010, Austria
Dep. of Gynecology and Obstetrics, Landeskrankenhaus Salzburg
Salzburg, 5020, Austria
Department of General Gynecology and Gynecology Oncology, Medical University of Vienna
Vienna, 1090, Austria
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.
Primary Completion
February 2021
Actual (reported)Study Completion
February 2021
Actual (reported)Last Updated
April 14, 2021
Record last verified: 2021-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: