Treatment Study for Actinic Cheilitis Comparing Imiquimod 5% and Photodynamic Therapy

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Actinic cheilitis is a common precancerous lesion of the lip. The purpose of this study is to compare imiquimod 5% therapy and photodynamic therapy. The data will include effect data, histology (skin analysis), epidemiological data and follow-up data.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Norwegian University of Science and Technology
• Collaborator: St. Olavs Hospital
• Treatments: Imiquimod

Criteria

Inclusion Criteria:

• Clinical findings of actinic cheilitis.

• Histological findings demonstrating epithelial changes equal to or greater than mild epithelial dysplasia in severity (mild - moderate - severe).

• Age above 18.

• Willingness to take post-treatment biopsy.

Exclusion Criteria:

• Disorders predisposing to photosensitivity (porphyria, SLE).

• Pregnancy or nursing.

• Known allergy to any excipients in the study creams.

• prescribed topical retinoids, 5-fluorouracil, cryodestruction, surgical excision and curettage.