Clinical Trial: Photodynamic Therapy for Oral Precursor Lesions

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

Official Title: A Randomized Controlled Trial: Photodynamic Treatment for the Therapy of Premalignant Mucosal Oral Lesions.

Brief Summary: Pre-malignant lesions are difficult to treat. Even after surgical removal they tend to re-appear. Often the lesions are to large and are apparent on many sites, therefore surgical removal is not always possible. The photodynamic therapy uses a special substance, which is absorbed in cells, and thereafter activated by a defined light. The aim of this study is to compare the photodynamic therapy in potentially malignant lesions to a placebo. The investigators assume a significant better result in photodynamic therapy then treatment with a placebo.

Detailed Summary:
Sponsor: Medical University of Vienna

Current Primary Outcome: Changes in percent (%) of the initial area in mm2 assessed on recall appointment and by a blinded examiner on photographs with a caliper. [ Time Frame: each treatment average once a week, recall after 4 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome: pain due to treatment, assessed by visual analogue scale (VAS) [ Time Frame: each treatment, average once a week ]

Original Secondary Outcome: Same as current

Information By: Medical University of Vienna

Dates:
Date Received: December 9, 2011
Date Started: May 2011
Date Completion:
Last Updated: May 16, 2017
Last Verified: May 2017