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

Abstract

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.

Key Words::

• Silk N Blue Acne Vulgaris
• Phototherapy

Declaration of interest: The authors report no declarations of interest with Home Skinnovations. The authors alone are responsible for the content and writing of the paper.

Dr Gold performs research and speaks on behalf of Home Skinnovations Ltd., Shaar Yokneam, Israel. This study was funded by Home Skinnovations/Invasix.