Journal of cosmetic and laser therapy : official publication of the European Society for Laser Dermatology · 2013
Clinical and usability study to determine the safety and efficacy of the Silk'n Blue Device for the treatment of mild to moderate inflammatory acne vulgaris.
Клиническое исследованиеСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
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Gold Michael H, Biron Julie A, Sensing Whitney
Аннотация
INTRODUCTION: Home devices for acne vulgaris have emerged as a way to utilize our current light based technology for the care of our patients suffering from acne vulgaris.
MATERIALS AND METHODS: Patient received eight treatments with the Silk'n Blue device over a 4-week period. Follow-up visits were at 1 month and 3 months.
RESULTS: Seventeen subjects were entered into this institutional review board (IRB) approved clinical research project. There was a statistically significant decrease in mean acne counts from baseline through the follow-up visits, p = 0.002. Percent reduction was also statistically significant, p = 0.041. The study also showed that 36.4% of the patients had complete clearance with the study device. 100% of the patients showed full comprehension with the label for the device. There were no adverse events. Photos were captured.
DISCUSSION: The Silk'n Blue device has an array of 24 LEDs emitting a spectrum of light in the blue-violet range of light (405-460 nm). Subjects enrolled in this clinical trial clearly were able to understand the labeling for the device.
CONCLUSIONS: The Silk'n Blue device is a safe efficacious at home device for the treatment of mild to moderate inflammatory acne vulgaris.
MATERIALS AND METHODS: Patient received eight treatments with the Silk'n Blue device over a 4-week period. Follow-up visits were at 1 month and 3 months.
RESULTS: Seventeen subjects were entered into this institutional review board (IRB) approved clinical research project. There was a statistically significant decrease in mean acne counts from baseline through the follow-up visits, p = 0.002. Percent reduction was also statistically significant, p = 0.041. The study also showed that 36.4% of the patients had complete clearance with the study device. 100% of the patients showed full comprehension with the label for the device. There were no adverse events. Photos were captured.
DISCUSSION: The Silk'n Blue device has an array of 24 LEDs emitting a spectrum of light in the blue-violet range of light (405-460 nm). Subjects enrolled in this clinical trial clearly were able to understand the labeling for the device.
CONCLUSIONS: The Silk'n Blue device is a safe efficacious at home device for the treatment of mild to moderate inflammatory acne vulgaris.