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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.

Utilizing 5-aminolevulinic acid and pulsed dye laser for photodynamic therapy of oral leukoplakia – pilot study