Imiquimod Treatment of High-grade CIN

• Status: Unknown status
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

This multi-center, open-label, non-randomized controlled intervention study aims to investigate the treatment efficacy, side-effects and quality of life associated with imiquimod treatment of high-grade CIN lesions, as an alternative to surgical treatment by Large Loop Excision of the Transformation Zone (LLETZ). Non-surgical treatment may prevent side-effects associated with surgical treatment, such as premature birth in subsequent pregnancies. The study hypothesis is that approximately 75% of patients with high-grade CIN will be adequately treated with imiquimod.

120 women with a histological diagnosis of CIN2 or CIN3 will be included and allocated to one of two treatment arms according to their preference:

1. Imiquimod treatment arm(60 patients). Patients in this group are treated with vaginal imiquimod 5% cream during 16 weeks.

2. Standard treatment arm (60 patients). Patients in this group will undergo LLETZ treatment.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maastricht University Medical Center
• Collaborators: Clinical Trial Center Maastricht; Clinical Trial Center Maastricht B.V.
• Treatments: Imiquimod

Criteria

Inclusion Criteria:

• de novo CIN2 or CIN3 lesion, histologically confirmed by diagnostic biopsy

• age of 18 years or older

Exclusion Criteria:

• previous histologically confirmed high-grade CIN (CIN 2-3)

• concomitant vulvar and/or vaginal intraepithelial neoplasia

• previous cervical malignancy

• current malignant disease

• immunodeficiency (including HIV/AIDS and immunodepressive medication)

• pregnancy or lactation

• legal incapability