Enrollments Complete for Two Phase 2 ALA-PDT AK Trials

DUSA Pharmaceuticals (NASDAQ GM: DUSA) completed patient enrollment in its Phase 2 clinical trial studying the broad area application with 1-, 2-, and 3-hour drug incubation for the treatment of actinic keratoses (AKs) of the face or scalp. DUSA also completed enrollment in its pilot Phase 2 clinical trial studying the safety and efficacy of treating AKs on the upper extremities. Both studies will utilize the Levulan Kerastick (aminolevulinic acid HCl) Topical Solution, 20% with the BLU-U Blue Light Photodynamic Therapy Illuminator. The current label for Levulan Kerastick requires application of Levulan to individual AK lesions, but in these clinical trials, a broad area application method is being utilized, where Levulan is applied to an entire skin region. The face/scalp exploratory study recruited patients at 13 clinical trial sites across the US, enrolling a total of 233 patients and will evaluate the effect of incubation time, and spot versus broad area application method, on the safety and efficacy of Levulan PDT in the treatment of multiple AKs of the face or scalp and investigate the potential for reduction of the occurrence of AKs in the treatment areas. The extremities pilot study recruited patients at three clinical trial sites across the US, enrolling a total of 71 patients and will examine and compare the safety and efficacy of the broad area application method of Levulan PDT for the treatment of AKs on the upper extremities and to evaluate the effect of occlusion on the safety and efficacy of Levulan PDT, using blue light after a 3-hour incubation period.