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

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Journal of Cosmetics, Dermatological Sciences and Applications, 2018, 8, 25-34
http://www.scirp.org/journal/jcdsa
ISSN Online: 2161-4512
ISSN Print: 2161-4105
DOI:
10.4236/jcdsa.2018.81005 Mar. 20, 2018 25 J. Cosmetics, Dermatological Sciences and Applications
Evaluation of the Safety and Efficacy of
Continuous Use of a Home-Use High-Frequency
Facial Treatment Appliance
Tokuya Omi
Department of Dermatology, Queen’s Square Medical Facilities, Yokohama, Japan
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
(TE
WL), 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 b
e-
gun to be used, and at 2 weeks after completion of the 4-week treatment p
e-
riod (6 weeks from the study baseline). In addition, data obtained by subje
c-
tive evaluation by the subjects themselves on a visual analog scale (VAS) were
also analyzed. Furthermore, skin biopsies were obtained f
rom 3 subjects under
local anesthesia with a 3-mm punch on two occasions, the first before the a
p-
pliance 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 su
b-
jected to immunohistochemical analysis for proliferating cell nuclear antigen
(PCNA) and p53. There were no adverse reactions, and the treatment was e
f-
fective for skin color changes and w
rinkle improvement. The VAS results also
showed improvement in the skin sagging. Histopathological examination r
e-
vealed no marked changes in the epidermis and very mild lymphocytic infi
l-
tration in the upper dermis, mainly around the blood vessels and appen
dages.
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 r
e-
sults 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.
How to cite this paper:
Omi, T. (2018
)
Evaluation of the Safety and Efficacy of Co
n-
tinuous Use of a Home
-Use High-Frequency
Facial Treatment Appliance
.
Journal of Co
s-
metics
,
Dermatological Sciences and Appl
i-
cations
,
8
, 25-34.
https://doi.org/10.4236/jcdsa.2018.81005
Received:
February 12, 2018
Accepted:
March 17, 2018
Published:
March 20, 2018
Copyright © 201
8 by author and
Scientific
Research Publishing Inc.
This work is
licensed under the Creative
Commons Attribution International
License (CC BY
4.0).
http://creativecommons.org/licenses/by/4.0/
Open Access
T. Omi
DOI:
10.4236/jcdsa.2018.81005 26 J. Cosmetics, Dermatological Sciences and Applications
Keywords
Home Use Device, Rejuvenation, Radiofrequency, Histology, Skin
Measurement
1. Introduction
At present, many home-use beauty devices are available in the market. In partic-
ular, many products developed for facial treatment use light, e.g., a flash lamp or
a light-emitting diode (LED).
In this study, we evaluated the safety and efficacy of continuous use of a
home-use high-frequency facial treatment appliance that uses radiofrequency
(RF) waves, the “NEWA”.
2. Subjects and Methods
A total of 20 Japanese individuals (all females, aged 37 to 52 years) aged 30 years
or older with healthy skin who complained of facial skin sagging were given a
home-use high-frequency facial treatment appliance, the NEWATM (EndyMed
Medical Ltd., Israel; approved by the United States Food and Drug Administra-
tion [FDA] in August 2013), for continuous use, every alternate day, for 4 weeks
(Table 1). The subjects were instructed to use the appliance as follows: After face
Table 1. Age and sex of the subjects.
Subject No Age Sex
1 39 Female
2 48 Female
3 43 Female
4 43 Female
5 43 Female
6 42 Female
7 39 Female
8 47 Female
9 44 Female
10 40 Female
11 46 Female
12 43 Female
13 40 Female
14 52 Female
15 37 Female
16 40 Female
17 44 Female
18 38 Female
19 43 Female
20 37 Female
T. Omi
DOI:
10.4236/jcdsa.2018.81005 27 J. Cosmetics, Dermatological Sciences and Applications
cleansing and washing, a dedicated conductive gel (certified by the FDA) was to
be applied to the electrode of the appliance, and the appliance was to be moved
slowly in a circular motion continuously for 4 minutes, with the electrode in
contact with the face, from below the eyelid to the mandible. After 4 minutes,
when the high-frequency wave generation automatically ceased with the vibra-
tion of the appliance, the appliance was to be moved to the opposite side of the
face. The self-treatment was to be completed in approximately 8 minutes.
The following examinations were performed before the appliance began to be
used, at 2 and 4 week after it had begun to be used, and at 2 weeks after the
4-week treatment period (
i.e.
, at 6 weeks from the study baseline).
1) TEWL: Measured with Tewameter TM3000 (Courage + Khazaka)
2) Melanin and erythema levels: Measured with Mexameter MX18 (Courage +
Khazaka)
3) Sebum secretion level: Measured with Sebumeter SM815 (Courage + Kha-
zaka)
4) Changes in skin color (brightness): Facial images of the subjects were taken
using re-Beau SKIN IMAGING SYSTEM(R) (JMEC), a skin image analysis sys-
tem, to evaluate the changes in brightness (V: value) in the entire facial images
and in specified areas. Furthermore, the brightness (V) in fixed areas was auto-
matically measured by the system according to a program.
5) Evaluation of wrinkle improvement
Natural light images obtained at the start of study and at 6 weeks from the
study baseline with the “re-Beau SKIN IMAGING SYSTEM(R)” as described
above were randomly blinded, and wrinkles at the corners of the eyes were eva-
luated by two third-party photographevaluating physicians according to the
wrinkle grade guidelines of the Japanese Cosmetic Science Society.
6) A questionnaire survey on the subjects’ self-evaluation was conducted using
a self-rating system, etc.
VAS scores for the level of satisfaction with wrinkles/sagging (0: dissatisfied,
10: satisfied) and VAS scores for skin symptoms (dryness, redness, pigmenta-
tion, tingling; 0: no feeling at all, 10: strong feeling) were obtained.
Furthermore, to examine the histopathological changes, skin biopsies were
obtained in 3 subjects from the mandible region 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). The specimens obtained were stained with HE and subjected
to immunohistochemical analysis for PCNA and p53.
This study was conducted with the approval of the Ethics Committee of the
Japan Aesthetic Dermatology Symposium (July 27, 2016).
3. Results
There were no significant differences in the TEWL (Figure 1), melanin levels
(Figure 2), erythema levels (Figure 3) or sebum secretion level measured before
and at 2, 4 or 6 weeks after the study baseline.
T. Omi
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10.4236/jcdsa.2018.81005 28 J. Cosmetics, Dermatological Sciences and Applications
Figure 1. TEWL. The vertical axis shows TEWL, and the horizontal axis
shows time. There were no significant differences in the TEWL recorded
before and at 2, 4 or 6 weeks after the study baseline.
Figure 2. Melanin levels. The vertical axis shows melanin levels meas-
ured, and the horizontal axis shows time. There were no significant dif-
ferences in the melanin levels recorded before and at 2, 4 or 6 weeks after
the study baseline.
Figure 3. Erythema levels. The vertical axis shows the erythema levels
measured, and the horizontal axis shows time. There were no significant
differences in the erythema levels recorded before and at 2, 4 or 6 weeks
after the study baseline.
T. Omi
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10.4236/jcdsa.2018.81005 29 J. Cosmetics, Dermatological Sciences and Applications
In regard to the skin color changes, examination of changes in the brightness
(V: value) in the whole facial images and in specified areas revealed that the
brightness had improved significantly (p < 0.05) in both the left and right
cheeks. Evaluation of wrinkles at the corners of the eyes in natural light images
according to the wrinkle grade guidelines before and 6 weeks after the study
baseline revealed significant (p < 0.05) improvement in both the left and right
cheeks (Table 2).
Subjective evaluation by the study subjects themselves revealed an improve-
ment of the mean sagging score from 1.99 before the start of treatment to 5.60
after 4 weeks of treatment. However, by 2 weeks after completion of treatment (6
weeks from the study baseline), the mean score decreased to 4.53 (Figure 4). In
addition, the subjective evaluation of pigmentation also revealed that the mean
pigmentation score decreased from 6.91 before the start of treatment to 2.31 and
3.09 after two and four weeks of treatment, respectively. The mean score remained
Table 2. Evaluation of wrinkle improvement. Evaluation of wrinkles at the corners of the
eyes using natural light images according to the wrinkle grade guidelines revealed de-
crease of the mean scores in both the left and right cheeks from 3.08 before the appliance
began to be used to 2.74 at 6 weeks from the study baseline and from 2.87 to 2.32, respec-
tively, indicating a wrinkle-improving effect.
Left cheek
Subject No before after
1 2.5 1.5
2 3.5 2.5
3 3 2.5
4 3.5 4
5 3 2.5
6 3 2
7 3 3
8 3 2.5
9 3 2.5
11 3.5 3
12 2.5 4
13 3.5 3.5
14 5 4
15 1 1
16 2.5 2.5
17 4 2.5
18 3.5 3.5
19 4.5 4
20 1 1
T. Omi
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10.4236/jcdsa.2018.81005 30 J. Cosmetics, Dermatological Sciences and Applications
Right cheek
Subject No before after
1 3 1
2 2.5 2
3 2 1
4 2.5 3.5
5 2.5 2
6 3 2.5
7 3 2.5
8 3 2.5
9 3.5 3
11 1.5 1.5
12 3.5 3
13 3 3
14 5 4.5
15 1 1
16 3.5 3
17 3 1.5
18 3 2.5
19 5 4
20 1 0
Figure 4. Improvement in sagging (VAS method). The subjective evalu-
ation of sagging (0: dissatisfied, 10: satisfied) revealed an improvement
of the mean score from 1.99 before the appliance began to be used to
5.60 after 4 weeks of treatment. However, at 2 weeks after discontinua-
tion of use (6 weeks from the baseline), the mean score decreased to
4.53.
at 3.11 at 2 weeks after completion of treatment (6 weeks from the study base-
line). On the other hand, neither the medical examinations by physicians not the
responses of the subjects to the questionnaire revealed any dryness, redness or
T. Omi
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10.4236/jcdsa.2018.81005 31 J. Cosmetics, Dermatological Sciences and Applications
tingling associated with the use of the appliance.
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 at 1 week after treatment completion (5 weeks
from the study baseline) (Figure 5). Immunohistochemistry revealed strongly
positive staining for PCNA in the basal layer of the epidermis and positive
staining in almost all the layers of the epidermis at 5 weeks from the study base-
line (Figure 6). P53 staining was negative.
Figure 5. HE findings at 1 week after treatment completion (5 weeks
from the study baseline). There were no marked changes in the epider-
mis, and very mild lymphocytic infiltration in the upper dermis, mainly
around the blood vessels and appendages.
Figure 6. PCNA staining at 1 week after treatment completion (5 weeks
from the study baseline). PCNA was strongly positive in the basal layer
of the epidermis and positive in almost all layers of the epidermis.
T. Omi
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10.4236/jcdsa.2018.81005 32 J. Cosmetics, Dermatological Sciences and Applications
4. Discussion
Noninvasive and less invasive treatments, as compared to conventional cosmetic
surgery, including treatments using energy such as laser, visible right, infrared
radiation, electromagnetic waves (RF) and ultrasound and injection therapy,
tend to be preferred for facial treatment [1] [2] [3] [4] [5]. In addition, many
home-use products for facial treatment or depilation available in the market are
popular, because treatment using these products is more convenient than treat-
ment at medical institutions. When these home-use appliances are used, partic-
ular attention needs to be paid to the safety, because they are used by so-called
amateurs at home. However, there is little medically verified evidence of the
safety of such appliances.
This study was conducted to evaluate the safety and efficacy of one-month
continuous use of a home-use high-frequency facial treatment appliance, the
NEWA (EndyMed Medical Ltd., Israel), which is used to alleviate or improve fa-
cial skin sagging caused by aging by tightening the skin and improving the skin
elasticity, in Japanese individuals aged 30 years or older with healthy skin who
complained of facial skin sagging. NEWA has 3 independent RF generators, al-
though their power is low, and generates submicrowaves (a type of RF) between
3 pairs of bipolar electrodes in contact with the skin. The high-frequency phases
are somewhat different between the generators, so that interference is avoided
and electric fields are generated until depths according to the distance between
each pair of electrodes.
In addition, NEWA has safety features, in that it has a temperature sensor and
motion sensor, and if the skin temperature increases excessively for some reason,
such as continuous contact of an electrode with the same area, the high-frequency
wave generation will cease. It also automatically ceases 4 minutes after the start
of high-frequency wave generation, preventing overtreatment.
Because NEWA uses RF waves as an energy source, energy may reach deeper
areas of the skin than in the case of light. Therefore, adverse reactions, such as
dryness, tingling, erythema and pigmentation on the skin surface, may occur. In
our study, we observed no significant changes of the TEWL, melanin levels or
erythema levels, and the above adverse reactions were objectively confirmed to
be absent. In addition, in the responses to the questionnaire survey, the subjects
did not report adverse reactions such as dryness, redness or tingling throughout
the study period.
Between July and December 2016, 5342 products have been shipped, and the
following adverse events have been reported: contact dermatitis due to the gel
(13/5342 cases, 0.24%), erythema with itching (7 cases, 0.13%), acne-like papules
(1 case, 0.01%) and metal allergy symptoms (1 case, 0.01%). From the data of the
present study and adverse reactions reported to date, the NEWA is considered to
be almost entirely safe as a home-use facial treatment appliance.
In regard to the efficacy, it is known that treatment with medical RF waves is
effective up to deeper layers of the dermis than laser treatment and also outside
T. Omi
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10.4236/jcdsa.2018.81005 33 J. Cosmetics, Dermatological Sciences and Applications
the irradiated area. The use of the appliance also resulted in improvement of the
wrinkles at the corners of the eyes, as evaluated according to the wrinkle grade
guidelines of the Japanese Cosmetic Science Society [6] at 6 weeks from the
study baseline. It is speculated that the effect of 4-weeks’ treatment persisted for
at least 2 further weeks, although no time-course evaluation was performed. The
VAS score for sagging skin also improved throughout the study period (from
before to 4 weeks after the study baseline). The score somewhat worsened again
at 6 weeks from the study baseline. This could be because of actual worsening of
the sagging due to discontinuation of treatment, however, the psychological in-
fluence of treatment discontinuation can also not be ruled out. Although there
are problems with the definitions of the words, wrinkles and sagging, it can be
said that facial beauty was improved in general. The VAS score for pigmenta-
tion, although subjective, decreased, and it can be said that the subjects them-
selves at least felt that there was an improvement in the skin color, if not an ac-
tual decrease in pigmentation.
Histopathological examination revealed no structural changes in the epider-
mal or dermal layers, but revealed very mild lymphocytic infiltration in the der-
mis. In addition, the epidermis showed a clearly positive reaction for PCNA as
compared to the control.
Many RF devices for medical facial treatment have been developed, and many
clinical and histological studies using these devices have been reported. The ap-
pliance used in this study, although the responses were weak, also uses similar
RF waves, which was most likely involved in the skin regeneration. It is specu-
lated to have contributed to both improvement of the wrinkles and that of sag-
ging skin, and improving facial beauty on the whole. The occurrence of a certain
degree of inflammatory cell infiltration and positivity for PCNA, which indicates
cell activation [5] [7], during the treatment are also consistent with the results of
the histopathological examination in this study. In particular, phototherapy is
often effective not only in the application area, but also outside the application
area, unlike cosmetics, etc., and partial treatment using medical devices is most
likely to lead to an improvement in the whole face [8]. The product used in this
study seems to have weak effects, because it is for home use, but it could contri-
bute to improving facial beauty, considering the mechanism of action of RF
waves.
The above results suggest the safety of NEWA, which was evaluated in this
study, as a home-use appliance, and that the appliance exerts a skin-improving
effect without downtime.
In many Western countries, legal standards for beauty equipment for medical
use and for beauty salon use have been established, but standards for home-use
beauty equipment vary [9] [10]. In Japan, almost all equipment is sold under the
category of miscellaneous goods. Burns and other troubles due to the strong
power of facial treatment appliances imported by agencies from China and Tai-
wan have also been reported. Likewise, administrative guidance has been given
T. Omi
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10.4236/jcdsa.2018.81005 34 J. Cosmetics, Dermatological Sciences and Applications
from the Consumer Affairs Agency, etc., for some appliances, because of the
emphasis of exaggerated effects in spite of having almost no effect. In the future,
for protecting consumers, it is essential to ensure sufficient safety of beauty
equipment and to fully evaluate their efficacy, even if they are intended for home
use.
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ResearchGate has not been able to resolve any citations for this publication.
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Different types of laser are used for resurfacing and collagen remodeling in cutaneous laser surgery. A systematic review was performed of the different types of laser currently employed for skin rejuvenation. These systems are either ablative [high-energy pulsed or scanned carbon dioxide (CO2) laser emitting at a wavelength of 10,600 nm, single- or variable-pulse or dual ablative/coagulative mode erbium:yttrium aluminum garnet (Er:YAG) laser emitting at a wavelength of 2940 nm, or systems combining both 10,600 nm and 2940 nm wavelengths] or nonablative [Q-switched neodymium:yttrium aluminum garnet (Nd:YAG) laser emitting at a wavelength of 1064 nm, Nd:YAG laser emitting at a wavelength of 1320 nm, or diode laser emitting at a wavelength of 1450 nm]. Different protocols, patient selection, treatment techniques, and complications are discussed for each system. New-generation CO2 resurfacing lasers have been successful in the treatment of photodamaged skin and scarring, with a postoperative morbidity dependent on the depth of thermal damage. Because of its minimal penetration, the pulsed Er:YAG laser, usually used in the treatment of more superficial rhytides, produces less postoperative morbidity. Novel ablative systems have been developed and a further understanding of laser-tissue interaction has led to the design of nonablative systems for the treatment of rhytides, scarring, and photodamaged skin, the efficacy and profile of which remain to be evaluated in the long term. There are several effective techniques for scar revision and the treatment of aged skin, but all have their drawbacks due to a lack of precise depth control and unwanted damage to the lower layers of the dermis. The Er:YAG laser is the treatment of choice for fine lines and superficial scars, whereas the CO2 laser is better for deeper rhytides and scars. In the future, a combination of lasers may be used for facial rejuvenation.
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Three years ago, the nonablative wrinkle reduction laser (a 585-nm laser, Chromogenex V3; Chromogenex Light Technologies, Llanelli, U.K.) was developed, and there have already been several reports about its clinical effectiveness. The Chromogenex V3 laser has also been reported to be effective in treating acne and atopic dermatitis. These results suggest that the Chromogenex V3 laser has some immunological role. In this study, we investigated immunological changes elicited by laser irradiation at the ultrastructural level and by analysis of interleukin (IL)-2 and IL-4 mRNA in skin homing T lymphocytes. Eight healthy adult volunteers (mean age 56.3 years, range 25-66 years) were recruited for this study. Ultrastructural analysis was done 3 h after the laser irradiation, as well as 1 day, 3 days, 1 week, 2 weeks, 4 weeks and 5 weeks later. IL-2 and IL-4 mRNAs in skin homing T cells cultured for 6 weeks were semiquantitatively measured using reverse transcriptase-polymerase chain reaction. Ultrastructural observations revealed that at 3 h after laser therapy, neutrophils, monocytes and mast cells could already be seen in the extravascular dermis. These dermal acute inflammatory changes were observed also at 1 week after laser treatment. Two weeks after laser treatment, the capillaries showed an almost normal structure. Four weeks after laser treatment, many lymphocytes and fibroblasts were observed. The numbers of these lymphocytes increased further at 5 weeks after the laser treatment. One week after the laser irradiation, all subjects were positive for IL-2 mRNA and for IL-4 mRNA. The level of IL-4 mRNA was larger compared with that of IL-2 mRNA in all subjects. The Chromogenex V3 is a 585-nm visible light laser, and it may affect the skin not only by selective photothermolysis but also by direct cutaneous immunological activation.