The FDA has granted Royal Philips 510(k) clearance to market the Philips BlueControl wearable light therapy device to treat mild psoriasis. In the US, BlueControl is a Class II prescription medical device designed for home use.
Clinical studies have demonstrated that the UV-free blue LED light emitted by Philips' BlueControl wearable device induces natural, drug-free processes in the skin to significantly reduce symptoms of mild psoriasis vulgaris, such as redness, scaling, and thickness of psoriasis plaques. Philips conducted two consecutive clinical studies in partnership with the University Hospital of Aachen in Germany to investigate the efficacy and safety of Philips BlueControl to reduce the symptoms of psoriasis vulgaris. In the second of these studies, patients were treated for a duration of three months. Eighty-four percent of patients showed an improvement in plaque symptoms (thickness, redness, and scaling) compared to the beginning of the study. In some cases, complete disappearance of the plaque was observed. Eighty-three percent of patients rated the usability and comfort of the device as ideal or excellent.
Designed with patients in mind, the company says the BlueControl's wearability provides complete freedom of movement. A patient can wear the rechargeable, battery-powered device comfortably on affected areas such as the arms, legs, elbows and knees using the adjustable straps. Philips obtained CE-marking for its BlueControl device in 2015, and has been successfully marketing it in selected countries in Europe, including Germany and the UK. Following the FDA clearance, Philips will start to engage with dermatologists and patient support groups in the US and prepare for the commercial launch of BlueControl in the US market in early 2018.
"As a company, we aim to improve people's health with a broad portfolio of proven therapy solutions to enable patients with chronic conditions to manage their health at home," said David Aubert, General Manager of Philips' Light & Health business. "Philips BlueControl is a clinically proven light therapy device that can be easily integrated into a patient's daily routine. We are pleased that we can now start marketing this innovative home treatment solution for psoriasis to dermatologists in the U.S., so that they will be able to prescribe Philips BlueControl to their patients."Next Story