Clinical trial NCT01861535: Primary Imiquimod Treatment Versus Surgery for Vulvar Intraepithelial Neoplasia
Official title: Primary Imiquimod Treatment Versus Surgery for Vulvar Intraepithelial Neoplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vulvar Intraepithelial Neoplasia
Keywords: VIN
Imiquimod
Surgery
HPV
Patient satisfaction
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
Collaborators: name: Austrian Science Fund (FWF)
First posted: 2013-05-23
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Complete clinical response
timeFrame: 6 months
Secondary outcomes:
measure: Clinical response/ lesion size
timeFrame: 6 months
measure: Histologic response
timeFrame: 6 months
measure: Extent of surgery
timeFrame: 6 months
measure: HPV status
timeFrame: 6 months
measure: Clinical response/lesion size
timeFrame: 12 months
measure: Extent of surgery
timeFrame: 12 months
measure: HPV status
timeFrame: 12 months
Other outcomes:
measure: "Cervical Dysplasia Distress" Questionnaire
timeFrame: 6 months
measure: "Cervical Dysplasia Distress" questionnaire
timeFrame: 12 months
measure: "Fear of Progression" Questionnaire
timeFrame: 6 months
measure: "Fear of Progression" questionnaire
timeFrame: 12 months
measure: "Sexual activity" Questionnaire
timeFrame: 6 months
measure: "Sexual activity" questionnaire
timeFrame: 12 months
measure: Immune cells in the epidermis
timeFrame: 6 months
measure: Aesthetic results
timeFrame: 6 months
measure: Aesthetic results
timeFrame: 12 months
measure: Visual analogue scale (VAS) for assessment of pain and pruritus
timeFrame: 6 months
Locations:
city: Linz
country: Austria
facility: Dep. of Gynecology and Obstetrics, Landes Frauen- und Kinderklinik Linz
state: Oberösterreich
city: Graz
country: Austria
facility: Dep. of Gynecology, Krankenhaus Barmherzige Brüder Graz
state: Styria
city: Graz
country: Austria
facility: Department of Obstetrics and Gynecology/ Medical University of Graz
city: Innsbruck
country: Austria
facility: Department of Gynecology and Obstetrics, Medical University of Innsbruck
city: Klagenfurt
country: Austria
facility: Dep. of Gynecology and Obstetrics, Klinikum Klagenfurt
city: Leoben
country: Austria
facility: Dep. of Gynecology and Obstetrics
city: Linz
country: Austria
facility: Dep. of Gynecology, Krankenhaus Barmherzige Schwestern Linz
city: Salzburg
country: Austria
facility: Dep. of Gynecology and Obstetrics, Landeskrankenhaus Salzburg
city: Vienna
country: Austria
facility: Department of General Gynecology and Gynecology Oncology, Medical University of Vienna
Study officials:
affiliation: Medical University of Graz
name: Gerda Trutnovsky, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of Graz
name: Karl Tamussino, MD
role: STUDY_DIRECTOR
References:
citation: 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.