Levulan PDT aminolevulinic acid: Phase II data

A double-blind, U.S. Phase II trial in 70 patients with minimally to moderately thick AK on the upper extremities showed that broad area application of Levulan Kerastick for 3 hours with or without occlusion followed by DUSA's Blue Light Photodynamic Therapy Illuminator (BLU-U) met the primary endpoint of improving AK lesion clearance rate at week 12 vs. vehicle with or without occlusion. Specifically, Levulan Kerastick plus BLU-U produced lesion clearance rates at week 12 of 89% with occlusion (p<0.0001) and 70% without occlusion (p<0.0001) vs. 17% for vehicle with occlusion and 6% for vehicle without occlusion. Additionally, the use of occlusion significantly improved clearance rates when compared to application without occlusion. ...