Primary Imiquimod Treatment Versus Surgery for Vulvar Intraepithelial Neoplasia

• Status: Completed
• Trial end date: 2021-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Graz
• Collaborator: Austrian Science Fund (FWF)
• Treatments: Imiquimod

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