Clinical study to evaluate the efficacy and safety of home-used LED and IRED mask for crow's feet: A multi-center, randomized, double-blind, sham-controlled study

Abstract

Background: As the elderly population continues to grow, the demand for antiaging products is increasing concurrently. On our face, wrinkles begin to form first around the eyes, where the skin is the thinnest. Previous studies have suggested that irradiating the skin with light-emitting diode (LED)/infrared emitting diode (IRED) light at 600 to 660 nm/800 to 860 nm, stimulates the cells of the dermis and epidermal tissue and is effective in wrinkle improvement and antiaging. Therefore, we aimed to evaluate the efficacy and safety of low-level light therapy masks. Materials and methods: A randomized, sham device-controlled, double-blind clinical trial was conducted at 2 institutions. Sixty Asian descent individuals between the ages of 30 and 65 years who showed type II to V skin type on the Fitzpatrick scale were included. Among participants with a score of 2 to 4 on the crow's feet grading scale (CFGS) at rest (without expression), those who sought temporary improvement in both crow's feet were selected. The participants were categorized into 2 groups: the experimental group, which used a device with a combination of 630 nm LED (max 10 mW/cm3) and 850 nm IRED (max 10 mW/cm3), and the control group, which used the sham device. Efficacy evaluation included various evaluations, including the CFGS as rated by independent raters, CFGS scores assigned by investigators, and the Global Aesthetic Improvement Scale evaluation by both investigators and the participants. Results: After using the LED mask for 16 weeks, the CFGS score of the independent raters and investigators showed significant differences at 8, 12, and 16 weeks. In addition, considering the success criteria of this study, a comparison of independent raters showed an improvement rate of ≥69.2% (full analysis set [FAS]: 86.2%, per-protocol set [PPS]: 89.3%) and a difference of ≥49.2% from the control group (FAS: 69.5%, PPS: 72.6%). The change in scores from the baseline showed significant differences between the test group and the control groups at 8, 12, and 16 weeks for both independent raters and investigators. Conclusion: LED and IRED phototherapies at 630 nm and 850 nm, respectively, are effective, safe, well-tolerated, and painless treatment for skin rejuvenation.