Trial Information
Primary Imiquimod Treatment Versus Surgery for Vulvar Intraepithelial Neoplasia
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Complete clinical response
Outcome Description:
No clinical evidence of vulvar lesion, i.e. 100% reduction of primary lesion size
Outcome Time Frame:
6 months
Safety Issue:
Yes
Principal Investigator
Gerda Trutnovsky, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Medical University of Graz
Authority:
Austria: Agency for Health and Food Safety
Study ID:
KLI293
NCT ID:
NCT01861535
Start Date:
June 2013
Completion Date:
September 2016
Related Keywords:
- Vulvar Intraepithelial Neoplasia
- VIN
- Imiquimod
- Surgery
- HPV
- Patient satisfaction
- Neoplasms
- Carcinoma in Situ