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