Skin physiology and safety of microfocused ultrasound with visualization for improving skin laxity

Abstract

Purpose:
The efficacy of microfocused ultrasound with visualization (MFU-V; Ultherapy®) has been demonstrated in clinical studies and daily practice. However, data addressing skin physiology after MFU-V treatment are lacking. This observational evaluation was aimed to assess skin physiology before and after MFU-V treatment using noninvasive biophysical measurements.

Patients and methods:
Twenty-two female patients with moderate-to-severe skin sagging at the jawline and submental region on the Merz Aesthetics Scale obtained a single MFU-V treatment according to protocol. Skin function measurements focused on short-term effects up to 3 days and long-term effects up to 24 weeks after treatment. Skin temperature, transepidermal water loss, skin hydration, erythema, elasticity, and skin thickness and density were evaluated under standardized conditions. Pain was assessed using a validated numeric visual analog scale.

Results:
Skin temperature remained in a physiologic range and no significant increase was noted at day 3 after MFU-V treatment. Transepidermal water loss, hydration, and erythema values were fairly stable and showed no significant differences at short- and long-term measurements vs baseline. At week 4 after a single MFU-V treatment, gross and net elasticity values were significantly decreased (P=0.003 and P=0.0001, respectively), followed by significantly increased values at week 12 (P=0.015, P=0.046) and week 24 (P=0.001, P=0.049). Edema due to MFU-V treatment resolved without sequelae. For all patients, pain diminished shortly after treatment. No adverse events occurred during the 24-week follow-up period.

Conclusions:
MFU-V treatment is well tolerated and it does not alter the epidermal barrier function or physiology of skin. Significant increase in the elasticity of skin was observed at 12 and 24 weeks after a single treatment, which reflects improvement in dermal tissue function. These short- and long-term effects are congruous with the mode of action of MFU-V due to a proven intrinsic tissue remodeling process.

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Clinical, Cosmetic and Investigational Dermatology 2019:12 71–79
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ORIGINAL RESEARCH
open access to scientific and medical research
Open Access Full Text Article
http://dx.doi.org/10.2147/CCID.S188586
Skin physiology and safety of microfocused
ultrasound with visualization for improving
skin laxity
Martina Kerscher1
Arti Tania Nurrisyanti1
Christine Eiben-Nielson1
Susanne Hartmann2
Judith Lambert-Baumann2
1University of Hamburg, Division
of Cosmetic Sciences, Hamburg,
Germany; 2Merz Pharmaceuticals,
Frankfurt/Main, Germany
Purpose: The efficacy of microfocused ultrasound with visualization (MFU-V; Ultherapy®) has
been demonstrated in clinical studies and daily practice. However, data addressing skin physiol-
ogy after MFU-V treatment are lacking. This observational evaluation was aimed to assess skin
physiology before and after MFU-V treatment using noninvasive biophysical measurements.
Patients and methods: Twenty-two female patients with moderate-to-severe skin sagging
at the jawline and submental region on the Merz Aesthetics Scale obtained a single MFU-V
treatment according to protocol. Skin function measurements focused on short-term effects up
to 3 days and long-term effects up to 24 weeks after treatment. Skin temperature, transepidermal
water loss, skin hydration, erythema, elasticity, and skin thickness and density were evaluated
under standardized conditions. Pain was assessed using a validated numeric visual analog scale.
Results: Skin temperature remained in a physiologic range and no significant increase was
noted at day 3 after MFU-V treatment. Transepidermal water loss, hydration, and erythema
values were fairly stable and showed no significant differences at short- and long-term measure-
ments vs baseline. At week 4 after a single MFU-V treatment, gross and net elasticity values
were significantly decreased (P=0.003 and P=0.0001, respectively), followed by significantly
increased values at week 12 (P=0.015, P=0.046) and week 24 (P=0.001, P=0.049). Edema due
to MFU-V treatment resolved without sequelae. For all patients, pain diminished shortly after
treatment. No adverse events occurred during the 24-week follow-up period.
Conclusions: MFU-V treatment is well tolerated and it does not alter the epidermal barrier
function or physiology of skin. Significant increase in the elasticity of skin was observed at 12
and 24 weeks after a single treatment, which reflects improvement in dermal tissue function.
These short- and long-term effects are congruous with the mode of action of MFU-V due to a
proven intrinsic tissue remodeling process.
Keywords: skin lifting, tightening, neocollagenesis, epidermal barrier, elasticity, energy-based
device
Introduction
Patients with skin laxity of the face and neck often seek skin rejuvenation with non-
invasive, safe, effective, and rapid cosmetic treatments. Microfocused ultrasound
with visualization (MFU-V; Ulthera® System, Merz North America, Raleigh, NC,
USA) is characterized by precise delivery of ultrasound energy at predefined depths
with simultaneous visualization.1,2 This technology enables the induction of precise
thermal coagulation points of 65°C without damaging skin surface.3 It also targets the
superficial muscular aponeurotic system (SMAS) to produce focused thermal collagen
denaturation and subsequent neocollagenesis.4
Correspondence: Martina Kerscher
University of Hamburg, Division of
Cosmetic Sciences, Martin Luther King
Platz 6, D-20146 Hamburg, Germany
Tel +49 40 428 387 234
Email Martina.Kerscher@uni-hamburg.de
Journal name: Clinical, Cosmetic and Investigational Dermatology
Article Designation: Original Research
Year: 2019
Volume: 12
Running head verso: Kerscher et al
Running head recto: Skin physiology and safety of MFU-V
DOI: http://dx.doi.org/10.2147/CCID.S188586
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Kerscher et al
The MFU-V medical device is approved by the US
Food and Drug Administration. According to the CE-mark,
MFU-V is indicated for noninvasive lifting and sculpting
of the upper face, lower face, neck, and décolleté.5 Clini-
cal studies have demonstrated that MFU-V is effective as a
noninvasive lifting and sculpting device of the upper face,6
lower face,7 neck,8,9 and décolleté.10
Patients expect noninvasive cosmetic treatments, espe-
cially those intended for facial rejuvenation, to be effective
and safe with minimal recovery time. Reviews from clini-
cal studies and post-marketing use of MFU-V suggest that
energy-based devices can fulfill these desired parameters.11,12
The primary objective of this evaluation was to assess
skin physiology before and both short and long term after
MFU-V treatment in patients with moderate to severe skin
laxity at jawline and submental region.
Patients and methods
Design
This observational, single-center, open-label safety evalua-
tion was performed using anonymized data received through
objective standardized measurements for skin physiology in
routine practice. All participants were provided with detailed
written and oral information and written informed consent
was obtained before any treatments and assessments as
suggested by local ethics committee (Ethikkommission der
Ärztekammer Hamburg). The evaluation was performed in
accordance with the principles of the 1975 Declaration of
Helsinki. MFU-V was performed on-label for noninvasive
lifting and sculpting of the lower face and submental region.
Microfocused ultrasound with
visualization
MFU-V combines precise delivery of microfocused ultra-
sound to dermal/subdermal tissues, including the SMAS,
with simultaneous visualization of the treatment area. Before
delivery of microfocused ultrasound, an appropriate image
ensures heat delivery to the intended area. MFU-V is avail-
able commercially and consists of a control unit with touch
screen, a hand piece, and proprietary transducers (DeepSEE®,
Ulthera/Merz, Mesa, AZ, USA).
Cohort
Patients
Twenty-two healthy women with moderate-to-severe skin
laxity have been treated with MFU-V due to their clinical
needs and following available treatment guidelines. No con-
traindication existed in any of the patients (Table 1). Subjects’
characteristics were documented before MFU-V treatment
was performed. Soft-tissue laxity was assessed clinically
using the five-point Merz Aesthetics Scale (MAS) for the
lower face.13 Objective measurements of skin functions were
taken under standardized conditions before, immediately
after, and 12 and 24 weeks after MFU-V treatment.
Procedure
At baseline, ibuprofen (800 mg orally, once) was admin-
istered at the discretion of the treating physician and
participant 1 hour before treatment. A single MFU-V
treatment was performed on the lower face, submental
region, and neck according to the MFU-V treatment pro-
tocol consecutively with two transducers: one at 4.0 MHz
(depth of 4.5 mm, 350 lines in total) followed by one at 7.0
MHz (depth of 3.0 mm, 270 lines in total; Figure 1). Each
enrolled subject completed 12-week or 24-week follow-up
visits or both.
Biophysical evaluation
A number of biophysical parameters were measured to
assess the skin physiology prior to the MFU-V treatment,
Table 1 Inclusion and exclusion criteria for MFU-V treatment
Inclusion Exclusion
Female Pregnant or lactating
Age 30–65 years Open wounds or lesions in the treatment area; severe or cystic acne in the treatment area
MAS grade 2–3 for lower face/submental skin
laxity (moderate to severe)
Excessive skin laxity on the lower face and neck
Naïve to minimally invasive or surgical cosmetic
treatment
Presence of metallic stent or active implants in the treatment area
Willing and able to provide informed consent Mental illness
Willing to attend follow-up visits Inability to understand the protocol or to give written consent
History of minimally invasive aesthetic procedures (eg, dermal llers, laser therapy,
implants, dermabrasion, and deep facial peel) in the treatment area within the last 24
months
Abbreviation: MFU-V, microfocused ultrasound with visualization.
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Skin physiology and safety of MFU-V
immediately after treatment, and during each post-treat-
ment follow-up visit at day 3, week 4, week 12, and week
24 ( Figure 2). All measurements were obtained under
standardized dermatological laboratory condition with
an acclimatization period of at least 30 minutes in an air-
conditioned room at 20°C–21°C and relative humidity of
40%–50%. Parameters assessed were in vivo transepidermal
water loss (TEWL), skin hydration, erythema, viscoelastic-
ity properties, and skin thickness and density. Measure-
ments were taken from the same site on both cheeks using
a template.
Transepidermal water loss
TEWL was assessed using a Tewametry (Tewameter® TM
300; Courage & Khazaka, Cologne, Germany). In brief,
a hollow cylindrical chamber containing two hygro and
temperature sensors situated at different levels above the
skin surface measures relative humidity. The vapor pres-
sure difference between the two sensor sites determines the
TEWL and is given in grams per hour per square meter (g/
hour/m2).14 One continuous measurement of 30 seconds was
Figure 1 Treatment scheme for MFU-V treatment of lower face and submental
region.
Abbreviation: MFU-V, microfocused ultrasound with visualization.
Figure 2 Overview of visits and biophysical measurement of dermal function.
TewametrySkin Temperature
Skin Temperature
Pain scale
Tewametry
Mexametry
Tewametry
Mexametry
MAS
Corneometry
Mexametry
Day 0
(Baseline)
Day 0
(Post-treatment)
Short-term effect Long-term effect
Day 3Week 4Week 12 Week 24
Cutometry
Sonography
Sonography
Tewametry
Corneometry
Mexametry
Cutometry
Sonography
Tewametry
Corneometry
Mexametry
Cutometry
Sonography
Cutometry
Sonography
recorded at each visit at predefined localizations within the
treated areas.15
Stratum corneum hydration
Stratum corneum hydration was determined using Corneom-
etry (Corneometer® CM 825; Courage & Khazaka, Cologne,
Germany). Briefly, the measurement of the electrical capacity
of the stratum corneum directly correlates to hydration. The
measured capacity is given in arbitrary units (CM units),
ranging from 0 to 120, specifying very dry skin to <30 CM,
dry skin from 30 to 40 CM and normal skin >40 CM.16 Three
measurements were taken at each visit at predefined skin
locations within the treated areas.
Skin redness (erythema)
Erythema was measured using mexametry (Mexameter® MX
18; Courage & Khazaka, Cologne, Germany). The Mexam-
eter consists of 16 circularly arranged light-emitting diodes
that emit green, red, and near-infrared light at three specific
light wavelengths of 568, 660, and 880 nm. The Erythema
index is computed based on the intensity of the absorbed and
reflected green and red light for hemoglobin at wavelengths
of 568 and 880 nm, respectively.
Skin elasticity
Elasticity of the skin was assessed using cutometry (Cutom-
eter® MPA 580; Courage & Khazaka, Cologne, Germany). A
defined vacuum (–450 mbar) was applied to the respective
skin surface area and turned off to let the skin recover. A
probe with 2 mm diameters was used. The skin properties
were calculated from measurement of vertical deforma-
tion of the skin as well as timing using the software of the
instrument. The parameters of interest were gross (R2) and
net elasticity (R5).
Skin thickness and density
Both parameters were determined using an ultrasound scan-
ner with a frequency of 20 MHz (DUB® 20; Taberna Pro
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Kerscher et al
Medicum, Lueneburg, Germany). Sonographic assessment
of skin thickness was based on the intensity of reflected
ultrasound waves in the respective skin area. Skin thickness
was calculated based on values from amplitudes of reflected
waves and depths of the skin. The B-Scan mode was used to
determine skin density.
Skin temperature
Skin temperature was measured before, 30 minutes and 3 days
after the treatment using a thermistor (113050, Rochester,
Inc. Rochester, NY, USA). Temperature is measured by plac-
ing the half inch diameter surface probe of the thermistor on
the skin until equilibrium is reached (defined by a <0.2°C
change in temperature of >15 seconds).
Safety
Tolerability and safety assessments were performed imme-
diately after the MFU-V treatment and on follow-up visits.
Patients’ subjective pain assessment using a visual analog
scale (VAS; 11 points: 0= no pain, 10= worst pain imagin-
able) was performed immediately after treatment. At each
follow-up visit, all patients were examined for edema and
adverse events.
Statistical analysis
Statistical analyses were carried out with SPSS® v 22.0 (IBM,
Armonk, NY, USA). Kolmogorov–Smirnov test was used
to assess normal distribution of the data. A parametric t-test
for paired samples was applied on normally distributed data,
and the nonparametric Wilcoxon signed-rank test was used
when the data did not appear normally distributed. P-values
of ≤0.05 were considered as statistically significant, P-values
of ≤0.01 were considered as highly significant and very highly
significant when the P-value was P≤0.0001.
Results
Demographics
Twenty-two Caucasian women (mean age, 52.32±9.32
years; Fitzpatrick skin type, I–III; body mass index, 20–30
kg/m2) with moderate-to-severe skin laxity (mean MAS
score, 2.8±0.87) were treated with MFU-V and eligible for
evaluation.
Safety
No adverse events occurred during the course of the evalu-
ation, and no patients withdrew from the evaluation due to
an adverse event. Dermal edema in the treatment area was
observed 3 days after MFU-V but resolved completely by
week 4. Sonography illustrated a representative example of
the course of edema (Figure 3).
Self-assessment of pain during MFU-V treatment of
the lower face and submental region revealed minimal-
to-moderate pain (VAS score, 1–5) for 15 cases, with 7
patients reporting minimal pain and 6 patients reporting
moderate pain. For all patients, pain diminished shortly
after treatment.
Figure 3 Course of edema: (A) before MFU-V, (B) edema at 72 hours after MFU-V, and (C) resolution of edema.
Abbreviation: MFU-V, microfocused ultrasound with visualization.
Baseline
ABC
72 hours after MFU-V treatment 4 weeks after MFU-V treatment
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Skin physiology and safety of MFU-V
Skin temperature
Mean skin temperature was significantly increased imme-
diately after treatment (P<0.05) from 31.536°C ± 1.369°C
at baseline to 32.323°C ± 1.315°C. Measurements at day 3
after MFU-V treatment showed decreased mean values of
31.468°C ± 1.08°C (Figure 4).
Transepidermal water loss
Evaporimetry demonstrated physiologic values before,
immediately after, and 3 days after treatment (Figure 5), as
well as at 4 and 12 weeks after MFU-V treatment for long-
term assessment (Figure 6). At baseline, mean values were
4.555±1.651 g/hour/m2. They were increased slightly imme-
diately after MFU-V to 5.295±2.145 g/hour/m2 and declined
to 4.755±2.175g/hour/m2 (day 3), 3.685±1.525 g/hour/m2
(4 weeks) and 4.702±1.517 g/hour/m2 (12 weeks). There
were no statistically significant increases for TEWL after
MFU-V treatment for either short- or long-term follow-up.
Hydration
Skin hydration (shown in Corneometer Units) showed a sig-
nificant decrease over 12 weeks, but values remained fairly
stable within the physiologic range before (54.31±12.69),
4 weeks (52.64±8.47), and 12 weeks (48.43±9.94) after
MFU-V treatment (Figure 7).
Erythema
The mean erythema level (shown in Mexameter Units) at
baseline was 313.70±76.11, and was increased slightly imme-
diately after treatment to 326.45±72.84 and decreased at day
Figure 4 Skin temperature before, immediately, and 3 days after MFU-V treatment.
Abbreviation: MFU-V, microfocused ultrasound with visualization.
Skin temperature
35 P=0.011
34
33
32
31
30
29
Baseline Post treatment
Temperature (°C)
3 days
Figure 5 Transepidermal water loss short term after MFU-V treatment.
Abbreviation: MFU-V, microfocused ultrasound with visualization.
Short-term measurement of transepidermal water loss
g/hour/m2
10
8
6
4
2
0
Baseline Post treatment 3 days
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3 after treatment to 321.36±70.19 (Figure 8). Erythema values
were further decreased at week 4 (293.63±69.51 MU) and at
week 12 (290.31±62.34 MU; Figure 9). Erythema values did
not demonstrate significant changes compared to baseline for
short-term or long-term evaluation.
Elasticity
A single MFU-V treatment targeting two preselected depths
of 4.5 and 3.0 mm led to a significant increase in net skin
elasticity at 12 and 24 weeks, respectively, compared with
that at baseline (P<0.05). After 4 weeks, the net elasticity was
significantly lower than that at baseline, suggesting physi-
ologic restructuring of collagen tissue. Skin gross elasticity
also showed decreased values at week 4, but significantly
increased values at weeks 12 and 24 (Figure 10).
Discussion
The effectiveness of MFU-V treatment has been demon-
strated in several clinical studies6–10 and its safety profile has
been assessed.12 However, prior to this evaluation, no struc-
tured data addressed the influence of MFU-V treatment on
epidermal/dermal physiologic and biomechanical parameters.
Furthermore, maintenance of skin integrity after treat-
ments for the lifting and tightening of skin is challenging,
because damage to the superficial skin layers is unwanted,
whereas neocollagenesis in deeper layers is desired. This
Figure 6 Transepidermal water loss long term after MFU-V treatment.
Abbreviation: MFU-V, microfocused ultrasound with visualization.
Long-term measurement of transepidermal water loss
8
6
4
2
Baseline
g/hour/m
2
4 weeks 12 weeks
Figure 7 Skin hydration up to 12 weeks after a single MFU-V treatment.
Abbreviation: MFU-V, microfocused ultrasound with visualization.
Skin hydration
Corneometerunit
80
60
40
20
Baseline 4 weeks 12 weeks
P=0.0001
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Skin physiology and safety of MFU-V
Figure 8 Short-term assessment of erythema.
Short-term effect on skin redness (Erythema)
500
400
300
200
Mexameter

unit
100
Baseline Post treatment 3 days
Figure 9 Long-term assessment of erythema.
Long-term effect on skin redness (Erythema)
500
450
400
350
300
250
200
Baseline
Mexameter

unit (MU)
4 weeks 12 weeks
clinical assessment focused on evaluating short- and long-
term physiologic effects of a single MFU-V treatment on
skin of the lower face and submental region.
In the present evaluation we provided, for the first time,
data for biophysical skin assessments scheduled around
MFU-V treatment. We found that after MFU-V treatment,
the essential protective skin functions remained in the physio-
logic range and parameters representing skin tightening were
improved. Skin temperature increased within a physiologic
range immediately after MFU-V treatment, but there was no
significant increase at day 3 after treatment. This observa-
tion suggests that MFU-V treatment results in heat being
introduced precisely at small thermal coagulation points at
intended predefined depths of 4.5 and 3.0 mm.
The epidermal barrier was not disturbed after MFU-V
treatment as TEWL, skin temperature, skin hydration, and
erythema values did not change significantly either within 3
days of MFU-V treatment or within a long-term follow-up at
24 weeks. These results suggest that this MFU-V technology
delivers microfocused ultrasound in a transcutaneous manner
without damaging the skin surface.
Net and gross elasticity, as measured by the firmness
and involution of the skin, were significantly improved
at weeks 12 and 24. These findings are consistent with
clinical studies demonstrating that MFU-V skin-tightening
effects most often occur 6 months post treatment, which
coincides with neocollagenesis and collagen conver-
sion.17 These data also demonstrate that MFU-V can be
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a promising and suitable treatment not only for patients
with slight loss of elasticity and skin contour of the face,
but also for patients with moderate to severe loss of facial
skin elasticity.
Dermal edema was assessed as a parameter of safety in
MFU-V treatment. The course of edema resolution might
be used as an indicator for wound healing in subsequent
combined minimal invasive or surgical cosmetic treat-
ments. The data of this structured assessment suggest that
dermal edema might be present 3 days after treatment, but
diminished completely by 4 weeks after treatment. Based on
these results, waiting for at least 4 weeks before performing
any subsequent skin tightening treatments may be prudent.
According to consensus recommendations for combined
aesthetic treatments, MFU-V might be an effective and safe
initial treatment in a combined aesthetic plan.18
Conclusion
MFU-V treatment of the lower face and submental region
did not alter skin barrier and skin physiology. However, for
the first time, we have demonstrated significant improvement
of viscoelastic properties of the skin 12 and 24 weeks post
treatment, thereby likely reflecting physiologic dermatologic
basis for lifting and tightening of treated areas.
Figure 10 Changes in skin elasticity at the upper face: baseline compared to 4, 12, and 24 weeks after a single MFU-V treatment: (A) net skin elasticity and (B) gross skin
elasticity.
Abbreviation: MFU-V, microfocused ultrasound with visualization.
Net elasticity
Net elasticity (%)
Gross elasticity (%)
0.5
A
B
0.4
0.3
0.2
0.1
Baseline Week 4Week 12 Week 24
P=0.049
P=0.046
P=0.0001
Gross elasticity
0.8
0.7
0.6
0.5
0.4
0.3
Baseline Week 4Week 12 Week 24
P=0.001
P=0.015
P=0.003
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Skin physiology and safety of MFU-V
Author contributions
MK conducted the evaluation performing visits and instru-
mental evaluations. ATN and CEN participated in data
analyses. SH, JLB, and MK participated in writing, critically
revising review, and approving the manuscript. All authors
contributed toward data analysis, drafting and revising the
paper, gave approval of the final version to be published and
agree to be accountable for all aspects of the work.
Disclosure
MK has received research support and has conducted clinical
trials for Merz Pharmaceuticals GmbH and has acted as a
speaker and/or investigator for Merz, Kythera, Q-Med/Gal-
derma, and Pierre Fabre. SH and JLB are employees of Merz
Pharmaceuticals. ATN and CEN are scientific employees
at the University of Hamburg. The authors report no other
conflicts of interest in this work.
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