DUSA Completes Enrollment for Phase IIb Trial of Levulan(R) Photodynamic Therapy for Moderate to Severe Acne
Monday March 31, 6:30 am ET
WILMINGTON, MASSACHUSETTS--(MARKET WIRE)--Mar 31, 2008 -- DUSA Pharmaceuticals, Inc.® (NASDAQ GM: DUSA), is pleased to announce today that the acne Phase IIb trial has achieved its goal of 260 participants, thus completing enrollment. The study's objective is to determine and compare the safety and efficacy of multiple broad area photodynamic therapy (PDT) treatments with Levulan® Kerastick® in combination with BLU-U® brand blue light versus use of the BLU-U alone in patients with moderate to severe facial acne vulgaris. This trial will evaluate the incremental advantage of adding Levulan to DUSA's already FDA-cleared BLU-U blue light therapy when treating acne.
"Completion of enrollment is an important milestone as DUSA looks to achieve a moderate to severe acne indication for Levulan PDT. Once the initial results are available, which we expect this fall, DUSA will decide on the next steps needed to develop this indication for potential FDA approval," said Bob Doman, President and CEO of DUSA. "DUSA continues to support trials in order to advance therapies that offer dermatologists innovative, effective treatments for their acne patients."
This DUSA-sponsored randomized, controlled, investigator blinded study is being conducted at 14 sites across the country. Levulan in topical solution or the solution without Levulan will be applied to the full face of participants approximately 45 plus minus 15 minutes prior to treatment with 5 or 10 J/cm2 of BLU-U light. Patients will receive treatment once every three weeks with a maximum of four treatments. The primary efficacy assessment will occur three weeks after the last treatment.
surf's up......crikey
