Efficacy and Safety of a Home-Use Light-Emitting Diode Neck Device for Improvement in Neck Wrinkles: A Multicenter, Randomized, Double-Blind, Sham Device, Superiority Verification, Confirmatory Clinical Trial

Abstract

Background: Light-emitting diode (LED) light sources have become an increasingly popular choice for the treatment and rejuvenation of various dermatological conditions. Aims: This study aimed to evaluate the effects of neck rejuvenation, patient satisfaction, and the safety of LED application to the neck in an Asian population. Methods: This was a multicenter, randomized, double-blind, sham device study. Seventy participants were enrolled in the study. The participants wore the home-use LED neck device for 9 min a day, 5 times a week, for a total of 60 sessions. The Lemperle Wrinkle Scale (LWS) and Global Aesthetic Improvement Scale (GAIS) were used to evaluate the results of both investigators and participants. The thyroid gland was examined using ultrasonography to evaluate the safety of the investigational device. Results: The percentage of participants with improved LWS at Week 12 was significantly higher in the study group. Additionally, the percentage of participants with improved LWS was significantly higher in the study group at Weeks 8, 12, and 16. The LWS at Week 12 corrected with baseline values was found to be significantly different between the two groups. GAIS showed significant differences at 8, 12, and 16 weeks in the investigators' evaluation but not in the participants' evaluation. Repeated-measures analysis of variance at Weeks 4, 8, 12, and 16 also confirmed a significant difference between the two groups only in investigator assessment. No significant thyroid-related complications were observed. Conclusion: LED application to the neck may be considered a satisfactory and safe procedure for neck rejuvenation.