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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.

Research paper by Michael H MH Gold, Julie A JA Biron, Whitney W Sensing

Indexed on: 23 Oct '13Published on: 23 Oct '13Published in: Journal of cosmetic and laser therapy : official publication of the European Society for Laser Dermatology



Abstract

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.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.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.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.The Silk'n Blue device is a safe efficacious at home device for the treatment of mild to moderate inflammatory acne vulgaris.