Primary Imiquimod Treatment versus Surgery for a precancerous condition of the vulva

Phase 1

• Conditions: Vulvar intraepithelial neoplasia; MedDRA version: 17.0Level: LLTClassification code 10056574Term: Vulval intraepithelial neoplasiaSystem Organ Class: 100000004872; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2012-002052-17-AT
• Lead Sponsor: Medizinische Universität Graz, Univ. Frauenklinik, Abteilung für Gynäkologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-09-12
• Last Update Posted: 17 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 110

Inclusion Criteria

•Histologically confirmed VIN (only usual type, formerly VIN 2-3)
•Visible, measurable lesion(s)
•Age 18 -90 years
•Contraception (for premenopausal women)
•Informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

•Evidence of invasion
•History of cancer or inflammatory dermatosis of the vulva
•Pregnancy, lactation
•Immunodeficiency
•Any treatment for VIN within the previous month
•Known hypersensitivity to imiquimod

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified