Lumenis Ltd has announced that its IPL Quantum SR is the only Intense Pulsed Light (IPL) system that will be used as part of a new multi-centre Phase II clinical study to be carried out at four locations in the US by DUSA Pharmaceuticals Inc, with whom Lumenis has signed a development agreement.
Lumenis was the first to introduce IPL technology into the aesthetic market. IPL provides gentle, non-ablative treatments that remove sun-induced freckles, most benign brown pigments, and redness caused by broken capillaries, a company release said.
The multi-centre study will focus on rejuvenation of photodamaged skin, a condition commonly resulting from exposure to sunlight. Published reports from leading physicians indicate that the DUSA drug Levulan, when used in conjunction with the IPL Quantum SR, may optimize non-ablative photorejuvenation of damaged skin.
Dr. Mitchel Goldman (La Jolla, CA), co-author of one of the published reports, stated, "As the developer of IPL and the continued leader in the creation of the most innovative IPL systems, Lumenis was the logical choice as the only IPL partner with DUSA in these very important clinical studies. We expect these studies to clearly demonstrate the significant enhancing effect of Levulan on skin treatments using photorejuvenation. As a result, millions of patients worldwide will benefit from the efforts of these two industry leaders."
The first of two phases in the clinical study will involve up to 64 patients and will establish the best light dosages for photodynamic therapy using the IPL Quantum SR. The second phase will involve up to 60 patients who will receive multiple treatments of fixed light doses. In both phases of the study, one side of each patient's face will be selected at random to receive a control treatment. The alternate side will be treated topically with Levulan.
The study will seek to demonstrate that treatment is improved when IPL is used in conjunction with Levulan. The combined procedure potentially brings great advantages to the thousands of Lumenis IPL systems now in use worldwide.