Radiation Tolerance clinical trials

Skin Safety Profile of Different Exposure to the Light Emitting Diode (LED) in Healthy Subjects

Photomodulation is a process which manipulates or regulates cell activity using light sources without thermal effect. Different studies have investigated the use of non-thermal low dose light emitting diode (LED) array for improving the appearance of photo aging damage. The photomodulation concept includes a low energy, narrow band or coherent light with specific pulse sequences and durations. Preliminary investigations done by McDaniel et al. demonstrated that fibroblast activity could be regulated using pulsing light at specific wavelenghts. Using a variety of LED light sources, his group has demonstrated that by varying light pulses and other parameters, procollagen synthesis could be upregulated in human skin fibroblast culture [McDaniel DH, et al.Lasers Surg Med. 2002; 14-251]. A clinical correlation was also shown based on different clinical trials data on around 1000 subjects, LED has shown up to 90% improvement in wrinkles and an increase of collagen synthesis versus control with little or no side effects associated [Weiss, RA et al. Lasers Surg Med 2005; 36(2): 85-91- Weiss, RA et al.: J Drugs Dermatol 2004; 3(6): 605-610 - Weiss RA et al. Dermatol Surg 2005; 31(9):1999-1204 - Russel BA et al. J Cosmet Laser Ther 2005; 7 (3-4):196-200 - Bhat J et al. Laser Med Sci 2005; 20(1):6-10]. Based on these promising clinical data, Light BioScience submitted a dossier to the Food and Drug Administration (FDA) and obtained in January 2005 the FDA approval for its GentleWaves® Light Emitting Diode (LED) for the non-invasive treatment of periorbital (eye area) wrinkles and rhytids. The LED technology has been considered by FDA as non significant risk. In Europe, the GentleWaves® Light Emitting Diode has obtained the notified body certification for the same indication. This medical claim is associated with cosmetic improvement of aging and sun-damaged skin, further validation the science of LED photomodulation skin rejuvenation [Investigator's Brochure. Version 1]. This approval has been obtained with a professional LED GentleWaves® device used under a physician's responsibility. The initial regimen of 35 seconds twice per week with at least two days in between treatment for a total of 4 weeks duration of treatment has demonstrated efficacy for the treatment of typical signs of photo aging and no adverse effect. A monocentre, randomized clinical study.