A Randomized Controlled Trial: Photodynamic Treatment for the Therapy of Premalignant Mucosal Oral Lesions. (PDT)

NCT01497951 Phase 3 COMPLETED

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.

Details

Lead sponsor	Medical University of Vienna
Phase	Phase 3
Status	COMPLETED
Enrolment	28
Start date	2011-05
Completion	2017-01

Conditions

• Leukoplakia
• Lichen

Interventions

• Aminolaevulinic acid
• Methylcellulose Placebo

Primary outcomes

• Changes in percent (%) of the initial area in mm2 assessed on recall appointment and by a blinded examiner on photographs with a caliper. — each treatment average once a week, recall after 4 weeks

Countries

Austria