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家用手持式多能量皮肤再生设备的疗效和安全性:临床、离体和组织学研究。

Efficacy and safety of a home-use handheld multi-energy-based device for skin rejuvenation: clinical, ex vivo, and histological studies.

机构信息

Department of Dermatology & Cutaneous Biology Research Institute, Yonsei University College of Medicine, 50-1 Yonsei Ro, Seodaemun-Gu, Seoul, 03722, Korea.

Scar Laser and Plastic Surgery Center, Yonsei Cancer Hospital, Yonsei University College of Medicine, Seoul, Korea.

出版信息

Lasers Med Sci. 2024 Jan 18;39(1):38. doi: 10.1007/s10103-024-03982-8.

Abstract

Alongside increases in the average lifespan and a growing interest in anti-aging remedies, the demand for at-home skincare devices is rapidly expanding in the cosmetic market. This study aimed to assess the safety and efficacy of a novel home-use handheld multi-energy-based device for skin rejuvenation that simultaneously emits low level light, low-dose radiofrequency, low-energy microcurrent, and low-intensity ultrasonic wave. This prospective, randomized, split-face clinical trial enrolled 36 healthy Korean women. After 8 weeks of device use, parameters associated with skin aging were assessed. Additionally, a preliminary ex vivo study and skin biopsy following device use were performed to confirm safety and efficiency of the device. Parameters associated with skin aging including skin hydration, elasticity, roughness, skin pore size, and eye wrinkle volume showed significant improvements after 8 weeks of the device use, relative to baseline measurements and the control side. No adverse effects were observed during the follow-up period. Results of ex vivo and in vivo skin tissue studies correlated with clinical findings, which showed an increase in the expression of type 1 collagen and a decrease in the expression of matrix metalloproteinase-1, which is related to the skin aging phenotype. The expression of loricrin and involucrin, major components of the epidermal skin barrier, also increased after the use of the device. Multi-energy-based device is effective for skin rejuvenation and tolerable, without any considerable adverse effects.

摘要

随着平均寿命的延长和人们对抗衰老疗法的兴趣日益浓厚,家用皮肤护理设备在化妆品市场的需求迅速扩大。本研究旨在评估一种新型家用手持式多能量皮肤再生设备的安全性和有效性,该设备同时发射低水平光、低剂量射频、低能量微电流和低强度超声波。这项前瞻性、随机、分面临床试验招募了 36 名健康的韩国女性。在使用设备 8 周后,评估了与皮肤老化相关的参数。此外,还进行了初步的离体研究和使用设备后的皮肤活检,以确认设备的安全性和有效性。与基线测量值和对照侧相比,使用设备 8 周后,与皮肤老化相关的参数(包括皮肤水分、弹性、粗糙度、毛孔大小和眼纹体积)均有显著改善。在随访期间未观察到不良反应。离体和体内皮肤组织研究的结果与临床发现相关,临床发现显示 1 型胶原蛋白表达增加,与皮肤老化表型相关的基质金属蛋白酶-1 表达减少。表皮皮肤屏障的主要成分丝聚合蛋白和兜甲蛋白的表达在使用该设备后也增加。多能量设备对皮肤年轻化有效且耐受,无明显不良反应。

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