Clinical trial · Interventional
Primary Imiquimod Treatment Versus Surgery for Vulvar Intraepithelial Neoplasia
NCT01861535CI-TRIAL-00051279PITVINcompletedPhase 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)
To evaluate the efficacy (defined as complete clinical response at 6 months) of imiquimod vs. standard treatment (surgery) for vulvar intraepithelial neoplasia (VIN).
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 |
|---|---|---|---|
| Vulvar Intraepithelial Neoplasia | Vulvar Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imiquimod | Drug | Imiquimod | ALIAS |
| Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Primary Imiquimod
- description
- 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
- interventionNames
- Drug: Imiquimod
- type
- ACTIVE_COMPARATOR
- label
- Primary surgery
- description
- 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.
- interventionNames
- Procedure: Surgery
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed VIN (only usual type, formerly VIN 2-3) * Visible, measurable lesion(s) * Contraception (for premenopausal women) Exclusion Criteria: * Evidence of invasion * 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
References
Publications (3)
- DERIVEDTrutnovsky 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. PMID 41791272
- DERIVEDMuntinga 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. PMID 41120128
- DERIVEDTrutnovsky 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. PMID 35483400