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Published by inbalw, 2017-10-17 02:18:41

NEWA Clinical studies summary_0469_B_PRINTFILE

NEWA Clinical studies summary_0469_B_PRINTFILE

Clinical Studies


Reduce wrinkles, Introduction
tighten and lift facial skin
NEWA® was created by EndyMed, a medical aesthetic company that offers energy based aesthetic
treatment systems for both the professional and consumer markets. EndyMed’s innovative, FDA cleared
3DEEP® RF technology is a clinically proven, effective solution for wrinkle reduction, skin tightening for the
face and body, cellulite reduction, fractional skin resurfacing, RF microneedling and acne scar treatment.
3DEEP® delivers focused energy deep into the dermis, providing painless, safe treatments. 3DEEP®
RF technology has been used in thousands of treatments by dermatologists, plastic surgeons, and skin
rejuvenation clinics worldwide.

EndyMed’s clinically proven 3DEEP® technology delivers focused RF energy 3 layers deep into the skin,
reactivating the skins natural collagen production to remove wrinkles and noticeably lift and tighten skin.
EndyMed has taken the same 3DEEP® technology which powers its medical/professional treatment
systems and has adapted it for NEWA®, so consumers can enjoy 3DEEP® treatments in the comfort and
convenience of their home.

EndyMed consistently invests in clinical studies to ensure that the 3DEEP® RF technology that powers
both the professional and consumer lines is the most effective and safest available today. With over
30 published peer-reviewed studies by international renowned dermatologists and plastic surgeons,
EndyMed is very proud to offer our clients the next level in the evolution of RF technology.

1


Contents

Reduce wrinkles, Clinical Assessment of the One Month NEWA® Treatment Protocol,
tighten and lift facial skin with Three Months Follow-Up

Study 01 3
4
Study 02 Clinicial Study on The Safety and Efficacy of The NEWA on Men and Dark 5
Skin Patients Skin Types V And VI 6
7
Study 03 Clinical Study of the Efficacy of the NEWA® in Combination with Lift 8
Activator gel

Study 04 Clinical Study of the Efficacy of the NEWA® in Combination with Active
Treatment Gels and Post Treatment Creams - A Pilot Study

Study 05 Clinical Assessment of the Efficacy of the NEWA® Device, NEWA®
Activator Treatment Gels and NEWA® Post Treatment Creams

Study 06 NEWA® vs. Top Branded Creams:
Clinical and Instrumental Comparison.

Study 07 Hypoallergenic Test 9

Study 08 NEWA® Effect On Skin Laxity (Japan) 9

2


Reduce wrinkles, Study 01 Clinical Assessment of the One Month
tighten and lift facial skin NEWA® Treatment Protocol, with Three Months Follow-Up

Study Design: Conclusions:
· 90% of subjects showed improvement in wrinkle appearance
■■ Participants:
69 participants (average age 54.3 years; 37-72 years old). after one month of treatment
Treatments were performed 5 times a week for three weeks, with a · Participants showed continued improvement after three
follow up evaluation after 3 months (without further treatment).
41 participants, with an average age of 57 (range of 39-77 years). months without additional treatments
· Participants reported that the NEWA® was easy to use
Results: · No side effects were reported by the study participants

■■ Objective Assessments: Source: Neil S. Sadick MD et. al. Home Based Wrinkle Reduction Using a Novel Handheld Multisource
Objective assessments were performed according to the Phase-Controlled Radiofrequency Device. Drugs Dermatol. 2014;13(11):1342-1347.
Fitzpatrick’s Wrinkle and Elastosis Grading Scale by three impartial
Dermatologists. 4.8 Wrinkle Reduction:
· 36.6% average wrinkle reduction at the three month follow up Independent Dermatologist Assessment

evaluation Average Fitzpatrick Score of 3 Dermatologists
· 90% of subjects showed improvement at the completion of one
3.6
month of treatments 3.3
· 79% of subjects showed further improvement 3 months after the
3.1
completion of the treatment
Baseline 1 month of 1 month 3 month
■■ Subjective Assessments: treatments follow-up follow-up
· 89.1% of study participants noticed an improvement in wrinkle no treatments no treatments

appearance
· 72.7% rated the level of improvement as greater than 50%
· 91.8% of study participants reported that the NEWA® was easy

to use during treatments
· No side effects were reported by any of the study participants.

Baseline 1 month of treatments Baseline 1 month of treatments Baseline 1 month of treatments

3


Reduce wrinkles, Study 02 Clinicial Study on The Safety and Efficacy of The NEWA on Men and Dark Skin
tighten and lift facial skin Patients Skin Types V And VI

Study Design: Conclusions:

■■ Participants: · The Newa skin rejuvenation system was tested on users
44 participants, 22 women with skin types V and VI, and 22 men with dark skin and in men without any side side effects.
(53.05 ± 6.3 years) used the NEWA 5 times a week for 4 weeks.
Objective and subjective skin assessment were performed at · No side effects occurred during the treatments" and
Baseline, Week 4, Week 8 and Week 16. delete the rest which is very minor: "One subject noted
to have blotchy skin during the treatment that cleared
Results: spontaneously after 1 hour.

■■ Objective Assessment: Baseline 4 weeks follow up
· 40 participants completed the study. Assessments was
Baseline 4 weeks follow up
performed by Clarity™ image computerized wrinkle analysis
and by subjective questionnaires. % of users with improvement in wrinkle
· At week 16 (12 weeks after the end of 4 weeks’ treatment severity compared to baseline
89.7% showed a statistically significant objective reduction of
Wrinkles Severity (average 11.73%, p<0.001) and 84.6%% 82% 90%
showed a statistically significant objective reduction of Total
Wrinkle Count (average 22.90%, p<0.001). 68%
· No side effects occurred during the treatments. One subject
noted to have blotchy skin during the treatment that cleared
spontaneously after 1 hour.

■■ Subjective assessment highlights:
· 80% of the users would recommend NEWA to their friends.
· 75% stated "My skin looks and feels softer and smoother".
· 72.5% stated they feel more beautiful/attractive.
· 70% of the users look forward to using the NEWA again.
· 70 % stated "My skin looks and feels more fresh and

rejuvenated".
· 65% stated "My skin pores look smaller and less prominent".

Sadick N, Harth Y: A 12-Week Clinical and Instrumental Study Evaluating the Efficacy of a multisource
radiofrequency home use device for wrinkle reduction and improvement is skin tone, skin elasticity and
dermal collagen content. Journal of cosmetic and laser therapy, 2016..

4 weeks 8 weeks 16 weeks 4


Reduce wrinkles, Study 03 Clinical Study of the Efficacy of the NEWA ®
tighten and lift facial skin in Combination with Lift Activator gel

Study Design: ■■ Subjective assessment:
Comments from study participants at the 4 week follow up:
■■ Participants: · 89% stated “the test product immediately made my skin look
47 participants (ages 37-65)
3 treatments per week for the first 4 weeks, then twice a week and feel tighter”
for 8 more weeks · 78% stated “the test product immediately made my skin feel

Results: lifted”
· 82% stated “I would recommend to my friends”
■■ Objective Assessment: · 87% stated “I look forward to using the device again”
Methods used: expert assessment, image analysis, Cutometer,
Siascope. Sadick N, Harth Y: A 12-Week Clinical and Instrumental Study Evaluating the Efficacy of a multisource
Statistically significant results at the 12 week follow-up: radiofrequency home use device for wrinkle reduction and improvement is skin tone, skin elasticity and
· 93% of participants showed improvement in wrinkle severity dermal collagen content. Submitted.
· 100% of participants showed improvement in overall wrinkle
Conclusions:
appearance · An average increase of 3.82% of collagen production
· 72% of participants showed improvement in deep lines was reported. (Skin loses 1.5% of its collagen content
· Other statistically significant improvements reported at the 12 every year after the age of 30)
· 100% of participants showed an improvement in the
week follow-up: appearance of wrinkles
· reduced marionette lines (67% of users)
Baseline 1 month of treatments · increased elasticity (60% of users) Increase in Skin Collagen Increase in Skin Firmness 22
· lift effect (facial) (62% of users) Content (Percentage) (Percentage)
· lift effect (jaw line) (78% of users)
· increased radiance/glow (84% of users) 3.82 16
· improved skin texture/smoothness (69% of users)
· improved skin tone (67% of users) 2 13

· 84% of participants showed an improvement in firmness
by an average of 22.4%

· 55% of participants showed an improvement in elasticity by an
average of 48.6%

· 75.6 % of participants showed a statistically significant
increase in skin collagen content (an average increase of
3.82%)

Baseline 1 month of treatments

4 weeks 12 weeks 4 weeks 8 weeks 12 weeks

5


Reduce wrinkles, Study 04 Clinical Study of the Efficacy of the NEWA® in
tighten and lift facial skin Combination with Active Treatment Gels and Post Treatment Creams - A Pilot Study

■■ Study Design: ■■ Results:
A total of 18 users participated in this study.
Three pilot studies evaluating the efficacy of the NEWA® device NEWA® device + Brightening gel + Brightening cream
in combination with proprietary rinse off treatment gels and post · 31.7% lift in jaw line improvement was noted in 100% of users at
treatment creams were performed:
· NEWA® device + Brightening gel + Brightening cream 12 weeks (p<0.001)
· NEWA® device + Clarifying gel + Clarifying cream · 61.0% overall lightening of the skin (ITA) was noted at 4 weeks
· NEWA® device + Exfoliating gel + Wrinkle Corrector cream
· NEWA® device + treatment gels were used 3 times per week and 126.15% by 12 weeks. 

for the first month, then twice a week for 3 more months. Post NEWA® device + Clarifying gel + Clarifying cream
treatment creams were applied every night. · Reduction in pore appearance by 38.37% at 4 weeks (P<0.01)
· Improvement in skin tone clarity by 27.8% at 4 weeks (P<0.05)
· Improvement in overall skin appearance by 22.1% at 4 weeks

(P<0.05)

NEWA® device + Exfoliating gel + Wrinkle Corrector cream
· Jaw line lift was noted in 100% of users at an average of 27.8%

at 12 weeks
· Texture and smoothness improvement was noted in 100% of

users at an average of 24.1% at 12 weeks
· Radiance/luminosity was noted in 100% of users, improved by

an average 39.5% of users at 12 weeks

6


Reduce wrinkles, Study 05 Clinical Assessment of the Efficacy of the NEWA® Device, NEWA® Activator Treatment
tighten and lift facial skin Gels and NEWA® Post Treatment Creams

■■ Study Design: NEWA® device + Brightening gel + Brightening cream
41 participants, with an average age of 57 (range of 39-77 years).
Three treatments a week for the first month, followed by twice a 65%
week treatments for 3 more months.
1. NEWA® device + Lift Activator gel + Wrinkle Corrector cream 45% 50%
2. NEWA® device + Brightening gel + Brightening cream
3. NEWA® device + Clarifying gel + Clarifying cream
4. NEWA® device + Exfoliating gel + Wrinkle Corrector cream

■■ Results: 4 weeks 8 weeks 16 weeks
NEWA® device + Brightening gel + Brightening cream
Methods of Assessment: Expert grading – reduction of pores size

57.5% 55% NEWA® device + Brightening gel + Brightening cream

42.5% ■■ At 16 weeks:
· 65% improvement in luminosity
· 55% improvement in uneven skin tone.

4 weeks 8 weeks 16 weeks NEWA® device + Exfoliating gel + Wrinkle Corrector
cream
Methods of Assessment: expert grading of the improvement of uneven skin tone (brightening) · At 16 weeks, 50% reduction in pore size

NEWA® device + Exfoliating gel + Wrinkle Corrector cream Conclusions:
· Wrinkle reduction was reported for all 4 NEWA® +
50% gel + cream combinations.

30% 35%

4 weeks 8 Weeks 16 weeks

Methods of Assessment: Expert grading of the reduction of pore size

7


Reduce wrinkles, Study 06 NEWA® vs. Top Branded Creams:
tighten and lift facial skin Clinical and Instrumental Comparison.

■■ Study Design: Objective Siascope measurement:
17 users participated in this study (two groups of 8 and 9 · Increase in collagen measured by Siascope (at 12 weeks)
participants respectively, average age of 58.52 (51-64)) · Top Brand Cream 1: no improvement (actual measured

■■ Results: decreased)
· Top Brand Cream 2: no improvement (actual measured
Objective image analysis (Clarity 2D, 12 weeks):
Reduction of wrinkle severity: decreased)
· Top Brand Cream 1: an average of 3.25 % (improvement in · NEWA® device: 3.82% improvement in 75.6 % of users

55.6% of users)
· Top Brand Cream 2: an average 8.9 % (improvement in 87.5%

of users)
· NEWA® device: an average 13.3 % (improvement in 93% of

users)

Objective expert visual grading:

Jaw line lift at 12 weeks:
· Top Brand Cream 1: no improvement
· Top Brand Cream 2: no improvement
· NEWA® device: 9.28% improvement in 77.8% of users

Jaw line lift at 12 weeks, Visual expert Grading
0.39

Jaw line lift at 12 weeks, Visual expert Grading

 Improvment in Elasticity 46.3 48.89 0.07
Cutometer (%) 4W
 Improvment in Elasticity
Cutometer (%) 12W

1.2 2.2 2.2 5.0 NEWA® -0.74 NEWA®
Top Brand 1 Top Brand 2
Top Brand 1 Top Brand 2

8


Reduce wrinkles, Study 07 Hypoallergenic Test ■■ Study Design:
tighten and lift facial skin IRB approved, 60 participants were tested for a duration of 6
■■ Products Tested: weeks. The original patch sites exhibited no reactions during the
· NEWA® Lift Activator gel induction phase and the rest period. No other reactions were
· NEWA® Lift Activator gel for Delicate Skin noted.
· Branded ultrasound gel
Lab conclusion: all three tested products did not
induce dermal irritation and/or sensitization in
human subjects.

Study 08 NEWA® Effect On Skin Laxity (Japan)

Lift effect was assessed 15 minutes after a NEWA® treatment.
Using Vectra Face Camera comparisons, before and after
treatment images showed a significant elevation of 4.19mm on
average (P<0.001) of contour lines drawn on the cheek area.
· Volume of the cheek increased by 6.3 cc on average
· Photographic-based evaluation noticed an average improvement

of 0.76 VAS (Visual Analogue Scale, p<0.01)
· No adverse effects were observed

Published : Takahiro Fujimoto, Ph.D. The immediate result of facial skin laxity treated by NEWA® lift BIO
Clinica 29 (5), 2014 (No. 380) pp. 89-95.

9


ND_DOC00469 Rev B_Sep.201610


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