Evaluation of the Safety and Efficacy of Continuous Use of a Home-Use High-Frequency Facial Treatment Appliance

Abstract

The safety of 4 weeks’ continuous use of NEWA TM , a high-frequency facial treatment appliance, every alternate day at home was verified, and its efficacy was evaluated in Japanese individuals with healthy skin aged 30 years or older who complained of sagging of the facial skin. Transepidermal water loss (TEWL), melanin levels, erythema levels, sebum secretion levels, skin color changes and wrinkle improvement in the facial skin were measured before the appliance began to be used (study baseline), at 2 and 4 weeks after it had begun to be used, and at 2 weeks after completion of the 4-week treatment period (6 weeks from the study baseline). In addition, data obtained by subjective evaluation by the subjects themselves on a visual analog scale (VAS) were also analyzed. Furthermore, skin biopsies were obtained from 3 subjects under local anesthesia with a 3-mm punch on two occasions, the first before the appliance began to be used and the second at 1 week after the 4-week treatment period ( i.e. , at 5 weeks from the study baseline), and the specimens obtained were stained with hematoxylin and eosin (HE) for light microscopy and subjected to immunohistochemical analysis for proliferating cell nuclear antigen (PCNA) and p53. There were no adverse reactions, and the treatment was effective for skin color changes and wrinkle improvement. The VAS results also showed improvement in the skin sagging. Histopathological examination revealed no marked changes in the epidermis and very mild lymphocytic infiltration in the upper dermis, mainly around the blood vessels and appendages. Immunohistochemistry revealed strongly positive staining for PCNA in the basal layer of the epidermis and positivity in almost all layers of the epidermis at 5 weeks from the study baseline. P53 staining was negative. The above results suggest the safety of NEWA TM , which was evaluated in this study, as a home-use appliance, and also its efficacy to some extent for improving the beauty of the facial skin without any downtime.