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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized Prospective Study Comparing 5% Imiquimod and Photodynamic Therapy for Actinic Cheilitis

Brief 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.

Detailed Summary: Randomized study comparing imiquimod 5% with photodynamic therapy for actinic cheilitis. Histological, efficacy, epidemiological and clinical data will be collected.
Sponsor: Norwegian University of Science and Technology

Current Primary Outcome: clinical and pathological complete cure rates. [ Time Frame: 3 and 12 months after therapy ]

Original Primary Outcome: The end points of the study will be clinical and pathological complete cure rates. [ Time Frame: 3 and 12 months after therapy ]

Current Secondary Outcome: clinical, safety, epidemiological and histopathological data [ Time Frame: post-treatment ]

Through collecting patient data and post-treatment biopsy


Original Secondary Outcome: Provide clinical, safety, epidemiological and histopathological data to improve management of patients with AC. [ Time Frame: Through collecting patient data and post-treatment biopsy ]

Information By: Norwegian University of Science and Technology

Dates:
Date Received: February 23, 2009
Date Started: March 2009
Date Completion:
Last Updated: May 12, 2017
Last Verified: May 2017