Dusa Pharmaceuticals has reported the results from its multicenter Phase II clinical study of photodynamic therapy (PDT) using the company's Levulan (aminolevulinic acid HCl, ALA) Kerastick in combination with the company's BLU-U (Blue Light Photodynamic Therapy Illuminator), versus BLU-U with vehicle, for the treatment of moderate-to-severe acne vulgaris of the face.

The results of the study indicate that both Levulan BLU-U and BLU-U alone appear to effectively reduce the number of both inflammatory and non-inflammatory acne lesions. However, in the subset of patients with greater than 60 inflammatory lesions at baseline, Levulan BLU-U appeared to be more effective than BLU-U alone. Treatment was well tolerated in both arms of the study with no unanticipated adverse events being reported.

This 72-patient, investigator-blinded study was designed to examine various safety and efficacy parameters as a function of varying Levulan/vehicle incubation times, namely 15, 60 and 120 minutes. Patients were randomized within each incubation group so that 18 subjects received Levulan BLU-U and six received BLU-U alone. There were no formal placebo arms in this study. Up to four PDT treatments were given at two-week intervals.