Status:
COMPLETED
Primary Imiquimod Treatment Versus Surgery for Vulvar Intraepithelial Neoplasia
Lead Sponsor:
Medical University of Graz
Collaborating Sponsors:
Austrian Science Fund (FWF)
Conditions:
Vulvar Intraepithelial Neoplasia
Eligibility:
FEMALE
18-90 years
Phase:
PHASE3
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
- Histologically confirmed VIN (only usual type, formerly VIN 2-3)
- Visible, measurable lesion(s)
- Contraception (for premenopausal women)
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2021
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT01861535
Start Date
June 1 2013
End Date
February 1 2021
Last Update
April 14 2021
Active Locations (9)
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1
Dep. of Gynecology, Krankenhaus Barmherzige Brüder Graz
Graz, Styria, Austria, 8020
2
Dep. of Gynecology and Obstetrics, Landes Frauen- und Kinderklinik Linz
Linz, Upper Austria, Austria, 4020
3
Department of Obstetrics and Gynecology/ Medical University of Graz
Graz, Austria, 8036
4
Department of Gynecology and Obstetrics, Medical University of Innsbruck
Innsbruck, Austria, 6020