Imiquimod Treatment of Residual or Recurrent CIN Lesions: a Study Protocol

• Status: Unknown status
• Trial end date: 2020-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to investigate if imiquimod can be used as a non-invasive option in the treatment of residual/recurrent CIN lesions.

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

Details

• Lead Sponsor: Erasmus Medical Center
• Collaborators: Albert Schweitzer Hospital; Catharina Ziekenhuis Eindhoven; Maastricht University Medical Center; Meander Medisch Centrum; meander medisch centrum Amersfoort; Sint Franciscus Gasthuis
• Treatments: Imiquimod

Criteria

Inclusion Criteria:

• Histologically proven CIN 2 or CIN 3, without invasion after previous surgical treatment at least 6 months before diagnosis.

• Histologically proven recurrent CIN 1 after previous surgical treatment at least 6 months before diagnosis. Persistent CIN 1 is defined as CIN 1 at least persistent for 6 months and proven with histology.

• The patient is willing to use a medically acceptable method of contraception throughout the study

• Women older than 18 years of age.

Exclusion Criteria:

• Pregnancy or lactation

• (Micro-)invasive carcinoma

• Past history of cervical cancer

• Hypersensitivity of any components of the formulation

• History of psoriasis or other inflammatory dermatosis of the vulva

• Immunodeficiency or treatment with immunosuppressive medication

• Insufficient understanding of the Dutch or English language