DUSA Pharmaceuticals, Inc. (NASDAQ NMS:DUSA), is pleased to report the presentation of an independent investigator study in which complete clearance of facial acne was observed in 14/14 patients (100%) treated with the combination of Levulan(R) (aminolevulinic acid HCl, ALA) Photodynamic Therapy (PDT) with long pulse dye laser (LPDL) for recalcitrant inflammatory acne vulgaris of the face. The independent investigator study, conducted by Macrene Alexiades-Armenakas, M.D., Ph.D, an instructor of clinical medicine at Yale University School of Medicine, was presented by the author on October 27th, 2005 at the American Society for Dermatological Surgery Annual Meeting in Atlanta, GA. The prospective, controlled pilot study was carried out to examine the safety and efficacy of PDT using topical Levulan activated by LPDL (Vbeam(R), 595 nm) energy in patients with acne (acne vulgaris) of the face. Nineteen consecutive patients with recalcitrant comedonal, inflammatory, and/or mild to severe cystic acne were accrued to the study. All had failed conventional therapy, including oral antibiotics, topical treatments, hormonal therapy, laser procedures (without Levulan), and/or oral isotretinoin (Accutane(R)). Fifteen patients were treated with Levulan PDT. Four patients served as controls. All were continued on their pre-existing topical medications. The treatments were administered by applying Levulan to the entire face for a 45 minute drug incubation, followed by a single pass of the LPDL with dynamic cooling spray. Treatments were repeated every four weeks until the acne was eliminated. A mean of three treatments was required to achieve complete clearance. Patients treated with conventional therapy served as control groups. Patients were followed monthly for up to 13 months. Complete skin clearing was maintained for a mean follow-up time of 6.4 months (range 1-13). In the LPDL-only control group (n equals 2), clearing of acne did not occur after three to four treatments. In the oral antibiotics, oral contraceptives and topicals control group (n equals 2) elimination of acne was not achieved after six to 10 months of treatment. LPDL-mediated PDT treatments were well tolerated. The most consistent side effect was minimal redness (erythema) lasting one to two days. A reduction in the redness seen in erythematous acne scars was also reported.
