Abstract
Methods A total of 24 subjects, between 18 80 years old, with a confirmed diagnosis of leukoplakia with or without dysplasia, measuring at least 10 mm in diameter were enrolled in cohorts of 3 within 24 months. Twenty percent solution of 5-ALA, Levulan Kerastick were applied to the lesions, for 1 to 3 hours, by utilizing custom fixtures made from hygienic polymer. The drug application was confirmed with Fluorescence diagnosis system (Dyaderm). High power pulsed dye laser emitting 585-nm wavelength was used to activate the 5-ALA. The laser dose was escalated from 6 to 8 J/cm. The safety was evaluated via clinical observation 48 hours post treatment, and the clinical and pathological efficacy were evaluated 30 and days after treatment, respectively. Histopathology and immunohistochemistry were conducted on fixed tissue samples collected at screening and 90 days post treatments, from the lesion and an adjacent healthy site.
Highlights
Observed in 46% of the subject treated in the efficacy phase of the study
More work is underway to determine the optimal laser radiant exposure and drug application to improve the rate of complete regression
Partial response was observed in 54% of the treated subjects and significant response was
Summary
Observed in 46% of the subject treated in the efficacy phase of the study. Conclusions Photodynamic therapy (PDT) with 5-Aminolevulinic Acid (5-ALA) and PDL could be use to regress oral leukoplakia.
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