Primary Imiquimod Treatment Versus Surgery for Vulvar Intraepithelial Neoplasia

NCT01861535 | Completed Phase 3 DMC

• 1 other identifier: KLI293
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 9

Brief Summary

To evaluate the efficacy (defined as complete clinical response at 6 months) of imiquimod vs. standard treatment (surgery) for vulvar intraepithelial neoplasia (VIN).

Conditions

Vulvar Intraepithelial Neoplasia

Keywords

VIN; Imiquimod; Surgery; HPV; Patient satisfaction

Outcome Measures

Primary Outcomes (1)

• Complete clinical response

  No clinical evidence of vulvar lesion, i.e. 100% reduction of primary lesion size

  6 months

Secondary Outcomes (7)

• 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

Other Outcomes (10)

• "Cervical Dysplasia Distress" Questionnaire

  6 months

• "Cervical Dysplasia Distress" questionnaire

  12 months

• "Fear of Progression" Questionnaire

  6 months

Study Arms (2)

Primary Imiquimod

EXPERIMENTAL

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

Drug: Imiquimod

Primary surgery

ACTIVE COMPARATOR

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.

Procedure: Surgery

Interventions

Imiquimod DRUG

Also known as: Aldara

Primary Imiquimod

Surgery PROCEDURE

Also known as: Excision, Ablation

Primary surgery

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed VIN (only usual type, formerly VIN 2-3)
• Visible, measurable lesion(s)
• Contraception (for premenopausal women)

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Graz: lead
• Austrian Science Fund (FWF): collaborator

Study Sites (9)

Dep. of Gynecology, Krankenhaus Barmherzige Brüder Graz

Graz, Styria, 8020, Austria

Location

Dep. of Gynecology and Obstetrics, Landes Frauen- und Kinderklinik Linz

Linz, Upper Austria, 4020, Austria

Location

Department of Obstetrics and Gynecology/ Medical University of Graz

Graz, 8036, Austria

Location

Department of Gynecology and Obstetrics, Medical University of Innsbruck

Innsbruck, 6020, Austria

Location

Dep. of Gynecology and Obstetrics, Klinikum Klagenfurt

Klagenfurt, Austria

Location

Dep. of Gynecology and Obstetrics

Leoben, Austria

Location

Dep. of Gynecology, Krankenhaus Barmherzige Schwestern Linz

Linz, 4010, Austria

Location

Dep. of Gynecology and Obstetrics, Landeskrankenhaus Salzburg

Salzburg, 5020, Austria

Location

Department of General Gynecology and Gynecology Oncology, Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (2)

• 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.

  PMID: 41120128 DERIVED

• 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.

  PMID: 35483400 DERIVED

MeSH Terms

Conditions

Patient Satisfaction

Interventions

Imiquimod; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Gerda Trutnovsky, MD

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

• Karl Tamussino, MD

  Medical University of Graz

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2013
• First Posted: May 23, 2013
• Study Start: June 1, 2013
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: April 14, 2021

Record last verified: 2021-04

Locations

AU (9)