ABSTRACT
The safety of 4 weeks’ continuous use of NEWATM, 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 NEWATM, 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.