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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.
TewametrySkin 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 P0.0001.
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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Kerscher et al
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.
80
60
40
20
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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Kerscher et al
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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CS. A prospective multicenter pilot study of the safety and efficacy of
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wrinkles of the décolleté. Dermatol Surg. 2015;41(3):327–335.
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... 13,[28][29][30] Other useful assessment methods include a pinch-test 19 and comparison of before and after photos. 31 Treatment: The treatment options to improve tautness include MFU-V, 23 CaHA (diluted), 32 and CPM ® -HA (25 mg, intradermal and subdermal). 20 MFU-V improves skin laxity, is safe in all skin types, and does not cause post-inflammatory hyperpigmentation (PIH). ...
... MFU-V is the only US Food and Drug Administrationcleared device for noninvasive lifting and tightening of the skin on the neck and brow, and under the chin and improvement in the appearance of lines and wrinkles on the décolleté. 23 Previous consensus recommendations agreed that MFU-V can be incorporated as part of combination therapy to safely and effectively treat the aging face. 3 The benefits of MFU-V include that it delivers ultrasound energy at precise, predefined depths with realtime visualization to target specific foundational tissues and trigger the natural healing process to result in gradual collagen and elastin production 83,84 and that it induces thermal coagulation points of 65°C without damaging the epidermal surface and preserves the skin's integrity. ...
Article
Full-text available
Introduction: Skin quality is an important component of human attractiveness. To date, there are no standardized criteria for good skin quality. To establish a consensus for good skin quality parameters and measurement and treatment options, a virtual skin quality advisory board consisting of a global panel of highly experienced aesthetic dermatologists/aesthetic physicians was convened. Methods: A total of 10 dermatologists/aesthetic physicians served on the advisory board. A modified version of the Delphi method was used to arrive at consensus. Members accessed an online platform to review statements on skin quality criteria from their peers, including treatment and measurement options, and voted to indicate whether they agreed or disagreed. Statements that did not have agreement were modified and the members voted again. Consensus was defined as: strong consensus = greater than 95% agreement; consensus = 75% to 95% agreement; majority consent = 50% to 75% agreement; no consensus = less than 50% agreement. Results: There was strong consensus that good skin quality is defined as healthy, youthful in appearance (appearing younger than a person's chronological age), undamaged skin and that skin quality can be described across all ethnicities by four emergent perceptual categories (EPCs): skin tone evenness, skin surface evenness, skin firmness, and skin glow. The EPCs can be affected by multiple tissue layers (ie, skin surface quality can stem from and be impacted by deep structures or tissues). This means that topical approaches may not be sufficient. Instead, improving skin quality EPCs can require a multilayer treatment strategy. Conclusion: This global advisory board established strong consensus that skin quality can be described by four EPCs, which can help clinicians determine the appropriate treatment option(s) and the tissue or skin layer(s) to address. Skin quality is important to human health and wellbeing and patients' perception for the need for aesthetic treatment.
... We have observed that 92% of the volunteers perceived greater firmness in the skin, a response already verified in other studies and related to the increase in the quantity and quality of collagen produced by fibroblasts. Clinically, tissue with unchanged epidermal function is observed, with a progressive increase in skin elasticity and histological remodeling of the dermis [19] [20]. ...
... Based on the literature findings, the clinical efficacy and patient satisfaction of MFU-high resolution were demonstrated in several clinical studies in Caucasian and Asian patients, and its safety profile was evaluated [28][29][30]. According to author Fabi, in his publications in the years 2014, 2015 and 2020, MFU-high resolution showed significant esthetic improvement for up to 180 days after a single treatment in women with moderate to severe lines of wrinkles [31][32][33]. ...
Article
Full-text available
Introduction: In the context of skin aesthetics, the spotlight is focused on non-invasive cosmetic procedures. Studies have shown that micro-focused transcutaneous ultrasound (MFU). A commercially available device combines MFU with high-resolution ultrasound imaging. Some clinical studies have shown clinical synergy of MFU-high resolution with poly-L-lactic acid and a fractional or diluted CO2 laser with calcium hydroxyapatite. Objective: A systematic review was carried out on the main clinical findings of the use of micro-focused ultrasound and collagen biostimulation, with or without combination with calcium hydroxyapatite and poly-L-lactic acid, in the aesthetics of human skin, to highlight the safety, efficacy, and risk of bias. Methods: The systematic review rules of the PRISMA Platform were followed. The research was carried out from May to June 2022 in Scopus, PubMed, Science Direct, Scielo, and Google Scholar databases. Scientific articles from the last 20 years were selected. The quality of the studies was based on the GRADE instrument. The risk of bias was analyzed according to the Cochrane instrument. Results: A total of 112 articles were found, and 12 articles were included in the systematic review. It has been shown that MFU-high resolution enables non-invasive tightening and lifting of sagging skin, and when combined dilute calcium hydroxyapatite, polycaprolactone, and/or poly-L-lactic acid is effective in improving sagging skin. Conclusion: It was concluded that MFU-high resolution targets the facial superficial musculoaponeurotic system, achieving non-invasive tightening and lifting of sagging skin, and when combined with dilute calcium hydroxyapatite, polycaprolactone, and/or poly-acid L-lactic is effective in improving sagging skin and cellulite.
... 16,22 It has been reported to be e ective for super cial skin rejuvenation and lifting tissues, as well as reducing skin laxity, ne lines and pore size. [23][24][25][26][27][28][29][30][31][32] MFU-V provides real-time visualization of distinct tissue layers beneath the skin surface, including the dermal and subdermal layers (super cial fascia, SMAS, and platysma), which allows precise delivery of microfocused ultrasound energy to the intended collagen-rich tissue planes (Supplementary Table 1). 16,22,33,34 MFU-V induces the creation of thermal coagulation points in the targeted tissue planes and stimulates the natural wound healing process to trigger the production of new collagen and elastin. ...
Article
Objective: We sought to examine the current skin quality trends and gaps in clinical practice in the Asia Pacific region and develop a practical guide to improve skin quality. Methods: Medical practitioners from 11 countries in the Asia Pacific region completed an online survey on current trends in skin quality treatment. A panel of 12 leading experts convened for a virtual meeting to develop a practical guide for skin quality improvement. Results: A total of 153 practitioners completed the survey. The four most common skin quality issues were uneven skin tone, skin surface unevenness, skin laxity, and sebaceous gland hyperactivity and enlarged pores. Most practitioners reported using a combination of treatment modalities for each skin quality issue. It was also observed that each treatment modality could be used to treat several skin quality issues. A multimodal approach targeting different interrelated issues across the tissue planes was recommended for balanced results. The panel developed a practical guide for the appropriate combinations and sequence of treatments, and created treatment protocols for specific skin quality outcome goals. The guide employed an "inside-out" approach, treating the deeper tissue planes prior to the superficial layers to achieve harmonious results. Limitations: Future studies are needed to support the recommended treatment protocols for skin quality improvement. Conclusion: These findings provide valuable insights on current skin quality trends and gaps in clinical practice. The practical guide provides a framework for practitioners to customize their treatment plan according to each patient's needs.
... Jones et al. 51 compared traditional HIFU with MFU-V for skin tightening over the neck region and found both the version to be equally effective though MFU-V resulted in greater discomfort levels. Kerscher et al. 52 used noninvasive biophysical measurements in 22 subjects to assess the skin physiology before and after MFU-V treatment. The parameters assessed included cutaneous temperature, transepidermal water loss, skin hydration, erythema, elasticity, skin thickness and skin density. ...
Article
Full-text available
Non-invasive body contouring modalities optimize the cosmesisof the human body safely and effectively and represent a fast-expanding domain of cosmetic dermatology. There are currently five approved modalities including cryolipolysis, radiofrequency, high-intensity focused ultrasound, laser therapy and high-intensity focused electromagnetic field. This article provides a brief overview of these modalities in the light of the recent literature.Key wordsObesity; Body contouring; Lipolysis; Laser; Radiofrequency; High frequency focusedultrasound; High-intensity focused electromagnetic field.
... Less aggressive methods include the use of nonsurgical therapies such as high-intensity focused ultrasound (Ultherapy; Merz Pharma, Frankfurt, Germany) or radiofrequency. [51][52][53][54] The next steps in mandibular contouring surgery should be aimed at obtaining more predictable results and establishing surgical techniques with a lower level of complexity. 37 In this respect, our group is working with a specific software that makes it possible to produce a virtual design of any type of ostectomy and obtain a lower bordersupported cutting guide, which provides greater control over the cut, reduces the complexity of the surgical technique, and notably decreases surgical times (unpublished observations). ...
Article
Background: Of the primary procedures associated with facial gender confirmation surgery, those involving the mentomandibular complex have received the least attention in the literature. Methods: The authors present their experience with 837 trans feminine patients operated on for facial gender confirmation surgery who underwent mandibular bone contouring procedures, including bone contouring, chin and mandibular body and angle ostectomies, and osteotomies to reposition the chin. The authors describe the surgical techniques and materials used, and present a customized lower border-supported cutting guide designed by their team and used with 205 patients. A femininity perception score was calculated preoperatively and 12 months postoperatively, and satisfaction with the results was measured 12 months postoperatively. Results: The postoperative follow-up ranged from 12 to 110 months. The mean femininity perception score increased from 47.86 preoperatively to 76.41 at 12 months postoperatively (p < 0.001). No emergency surgical operations were required. In no case was there any permanent damage to the mentonian or inferior dental nerve. The reoperation percentage because of problems detected during the postoperative period was 2.63 percent (22 patients). Conclusions: With facial gender confirmation surgery of the jawline and chin, it is possible to modify the transverse and vertical components of the jaw; soften the gonial angles; change the format, bone volume, and position of the chin; and harmonize the entire mandibular line. The facial feminization achieved high satisfaction scores regarding the results and feminine gender appearance 12 months after surgery. The future of mandibular bone contouring techniques includes planning with virtual software and surgical support with patient-specific cutting guides.
Article
Background: The experience of pain during microfocused ultrasound with visualization (MFU-V) treatment is common and crucial for dictating patient satisfaction and retention. Objective: To compare the pain perception during the MFU-V procedure between two pain reduction methods (topical anesthesia alone versus combined topical anesthesia with forced air cooling). Materials and methods: This was a prospective, single-blinded, randomized controlled trial. A square area on the inner side of both arms of healthy volunteers was marked as an experimental site and randomly assigned to receive each pain reduction method: topical anesthesia or combined topical anesthesia with forced air cooling. Thereafter, MFU-V was performed with a 4.5 MHz, 4.5 mm transducer (10 lines, 0.9 J) followed by a 7 MHz, 3.0 mm transducer (10 lines, 0.3 J). The visual analog scale (VAS) for pain was measured immediately after 4.5 mm transducer (T1a), immediately after 3.0 mm transducer (T1b), and after the entire procedure (T2). Results: Twenty-one participants with a mean (SD) age of 34.67 (±6.18) years were enrolled. The mean (±SD) pain score of combined topical anesthesia with forced air cooling-treated area was 5.40 (±1.64), 4.80 (±1.63), and 5.40 (±1.56) at T1a, T1b, and T2, respectively. The mean pain score for topical anesthesia-treated areas was 5.89 (±1.45), 5.00 (±1.72), and 5.76 (±1.67) at T1a, T1b, and T2, respectively. There were no statistically significant differences in the pain perception between the two methods. Conclusion: The addition of forced air cooling is not beneficial for pain reduction during the MFU-V procedure because its temperature reduction effect cannot be delivered to the deep parts of the skin, which is the target site of MFU-V.
Chapter
Ultrasonography plays an essential role in four major areas of aesthetic dermatology: (1) identification of the cosmetic filler; (2) diagnosis and follow-up of complications; (3) guidance for interventional procedures (as drainage of seromas/abscesses and application of hyaluronidase); and (4) cosmetic filling/botulinum toxin application. This review addresses the ultrasound relevance as a diagnostic tool and guiding method for interventional procedures in aesthetic dermatology.KeywordsUltrasoundaesthetic dermatologyInterventional dermatologyhyaluronidase FillersFiller ultrasoundDermatologic ultrasound
Article
Full-text available
Purpose of Review The skin laxity component of facial aging has been traditionally addressed with surgical intervention. However, demand for alternative treatment options with less associated risk, scarring, downtime, and cost have driven advances in non-surgical tightening techniques. This article explores the recent advances in these non-surgical technologies for skin tightening including microcoring, hydroxyapatite fillers, and energy-based devices (lasers, ultrasound, radiofrequency, and plasma). Recent Findings Advances in non-surgical skin-tightening devices allow for effective skin tightening. Although fully ablative laser resurfacing devices are often considered the gold standard for non-surgical rejuvenation, important advances in this technology include fractionated energy delivery to decrease risk and shorten treatment recovery. In addition, studies have shown that optimal treatment temperatures for skin tightening are lower than those achieved with CO2, favoring radiofrequency devices as a more optimal choice for tissue tightening in terms of treatment results, skin types amenable to treatment, risks, and downtime. Ultrasound technology has the unique advantage of allowing for real-time tissue assessment and tailored heat delivery. Microcoring and hydroxyapatite treatment stimulate skin tightening without heat production. Advantages and disadvantages of various non-surgical skin tightening are reviewed and summarized in this article. Summary A wide array of non-surgical skin-tightening techniques provide an attractive alternative to surgical intervention for modern cosmetic patients.
Article
Full-text available
Background: The aging process is a complex interplay of intrinsic and extrinsic factors across multiple layers of the face. Accordingly, combining aesthetic interventions targeting different manifestations of aging often leads to better results than single modalities alone. However, no guidelines for a pan-facial approach using multiple interventions have been published to date. Objective: To develop consensus recommendations for the optimal combination and ideal sequence of botulinum toxin (BoNT), hyaluronic acid, calcium hydroxylapatite, and microfocused ultrasound with visualization (MFU-V) in persons of all Fitzpatrick skin types. Methods and materials: Fifteen specialists convened under the guidance of a certified moderator. Consensus was defined as approval from 75% to 94% of all participants, whereas agreement of ≥95% denoted a strong consensus. Results: Optimal aesthetic treatment of the face begins with a thorough patient assessment and an individualized treatment plan. Spacing consecutive treatments 1 to 2 weeks apart allows for resolution of side effects and/or to assess results. For same-day treatments, BoNT and fillers may be performed together in either sequence, whereas MFU-V is recommended before injectable agents. Conclusion: Expert consensus supports a combination approach using multiple modalities in specific sequence for the safe and effective treatment of the aging face.
Article
Full-text available
In contrast with ultrasound imaging, therapeutic ultrasound uses high energy levels .5 W/cm 2 and is tightly focused into a small point to rapidly heat and coagulate targeted tissues. The use of high intensity focused ultrasound has recently expanded from high-precision surgical procedures into the field of noninvasive cosmetic medicine. Microfocused ultrasound (MFU) differs from other energy technologies used for skin rejuvenation. A concave disk within the transducer focuses ultrasound energy with very high intensity at specific locations below the epidermis and can specifically target the dermis or superficial musculoaponeurotic system, a fibrous network consisting of collagen fibers, elastic fibers, and fat cells that connects the facial muscles with the dermis and is tightened during a facelift. Where applied, the temperature at the focal point rapidly rises while tissue above and below the focal zone are unaffected. Application of MFU causes collagen fibers to denature and contract and stimulates de novo synthesis of new collagen. MFU combined with visualization (MFU-V) can be applied to the skin with a high degree of precision to noninvasively lift and tighten the dermis and subdermal tissues. The desired treatment depth and the rate of heating can be selected by altering the ultrasound frequency and rate and intensity of energy delivery. One MFU-V device has been approved by the US Food and Drug Administration to noninvasively lift and tighten lax face and neck skin. Common adverse events associated with MFU-V include momentary discomfort during the treatment session, transient erythema and edema, and occasional bruising. Ongoing studies by independent investigators are evaluating the safety and efficacy of MFU-V for lifting and tightening lax skin in other anatomical areas.
Book
Since the first edition of this book was published in 2004, to much acclaim, the pace of innovation in the field of skin metrology has increased and various new technologies have become available. This new, revised edition reflects these advances by presenting the current theory and practice of noninvasive investigation and measurement of the skin and its appendices in health and disease. The first, extensive part of this authoritative work is devoted to the physiology and metrology of the various structural components of the skin. Skin functions and their measurement are then discussed in detail, with sections on mechanical protection, photoprotection, barrier function, immune function, thermoregulation, and sensory function. In addition, careful consideration is given to skin disease rating and skin maps, and a unique list of physical and biological constants and units is provided. Not only is this new edition the first comprehensive, practical handbook in this domain - it will also serve as a manual of skin physiology and collates anatomical, functional, and physical quantitative data that would otherwise be arduous to retrieve because of their dispersal throughout the literature. It will prove a valuable resource for dermatologists, cosmetologists, bioengineers, physiologists, pharmacists, and all others who deal with the skin in their work. © Springer-Verlag Berlin Heidelberg 2004. All rights are reserved.
Article
Background: Micro-focused ultrasound with visualization has been cleared by the United States Food and Drug Administration to noninvasively lift the eyebrow, lift submental and neck tissue, and improve lines and wrinkles of the décolleté. Objective: The objective of this prospective, open-label pilot study was to evaluate the efficacy and safety of patient-specific, customized micro-focused ultrasound with visualization treatment with vertical vectoring to lift and tighten facial and neck tissue. Methods and materials: Subjects 25 to 60 years of age (N=20) with areas of skin laxity on the face and neck were enrolled and treated. A dual depth treatment was administered using a vectored pattern. Subjects were evaluated after 90 days, 180 days, and one year. Results: Overall improvements in Subject Global Aesthetic Improvement Scale and Physician Global Aesthetic Improvement Scale scores were reported by 90 and 100 percent of subjects at 90 and 180 days, respectively, and 95 percent for both measures at one year. Six of 14 evaluable subjects were rated as improved by blinded assessment at one year. Self-reported improvements maintained for up to one year included less sagging (79%), fewer lines and wrinkles (58%), and smoother skin texture (47%). Conclusion: Based on these results, treatment with micro-focused ultrasound with visualization with vertical vectoring demonstrated appreciable lifting and tightening of facial and neck tissue resulting in improved Global Aesthetic Improvement Scale scores and a high degree of patient satisfaction for up to one year. ClinicalTrials.gov Identifier: NCT01708512.
Article
A previous pilot study demonstrated microfocused ultrasound with visualization (MFU-V) to lift and tighten the décolleté produced significant and durable aesthetic improvements. To further evaluate the safety and effectiveness of MFU-V for improving lines and wrinkles of the décolleté in a larger patient population. Healthy women with moderate-to-severe décolleté skin lines and wrinkles were enrolled. After obtaining digital images, MFU-V was administered using 3 transducers emitting ultrasound at frequencies of 4 MHz and a focal depth of 4.5 mm, 7 MHz/3.0 mm, and 10 MHz/1.5 mm. During the procedure, 280 lines of discrete thermal coagulative points 25 mm long and 2 to 3 mm apart were applied to the treatment area. Additional imaging for masked assessments and live assessments were completed at 90 and 180 days. Among the evaluable subjects, 77 (66.4%) demonstrated aesthetic improvement at 180 days based on blinded assessments. Approximately, 75% and 65% of treated subjects demonstrated some degree of improvement at 90 and 180 days, respectively, and most were satisfied with treatment outcomes. Adverse events were generally mild. A single MFU-V treatment provided significant aesthetic improvement for moderate-to-severe décolleté lines and wrinkles for at least the 180-day duration of the study.
Article
The Safety of Microfocused Ultrasound with Visualization (MFU-V) has been well established in both controlled clinical studies and in clinical use, showing only mild and transient anticipated side effects and only rare unanticipated adverse events (AEs). This publication discusses the safety profile of MFU-V based on data from a variety of sources. Reports of side effects and AEs were obtained from published peer-reviewed medical literature, clinical studies, in-market use reports (AEs reported to the manufacturer), and retrospective chart reviews of patient treatments. Events that were typical included tenderness, redness, and slight edema. Rare events included bruising, welting, and nerve-related effects (paresthesia and paresis). Rare incidence of surface thermal effects was seen in some cases where improper technique was used. In all cases where the device was uses properly, the safety events reported tended to be transient, mild in nature, and resolved without sequelae. In general, unexpected and rare AEs could be attributed to incorrect treatment technique or classified as unrelated to MFU-V treatment. Side effects that do occur are generally mild and transient in nature. MFU-V consistently allows for safe treatment when correct treatment technique is used.
Article
Background: The Ulthera System (Ulthera, Inc, Mesa, Arizona) employs microfocused ultrasound to cause discrete focal heating of the dermis and stimulate neocollagenesis and elastin remodeling. Objectives: The authors investigated tightening and lifting of cheek tissue, improvement in jawline definition, and reduction in submental skin laxity in patients treated with the Ulthera System. Methods: A total of 103 adults were enrolled in this prospective nonrandomized clinical trial. Three-dimensional photographs obtained at baseline and 3 months posttreatment were assessed qualitatively by 3 blinded reviewers and quantitatively with AutoCAD software (Informer Technologies, Redwood City, California). The relationship between outcomes and body mass index (BMI) was examined as well. Patients rated pain during the procedure and provided subjective assessment of their outcome at 90 days. Adverse events were documented. Results: Ninety-three patients were evaluated. Blinded reviewers observed improvement in skin laxity in 58.1% of patients. During quantitative assessments, overall improvement in skin laxity was noted in 63.6% of evaluated patients. No change was detected in 54.5% of patients whose BMI exceeded 30 kg/m2 or in 12.2% of patients whose BMI was ≤30 kg/m2. At day 90, 65.6% of patients perceived improvement in the skin laxity of the lower half of their face/neck. The average procedural pain scores for the cheek, submental, and submandibular regions were 5.68, 6.09, and 6.53, respectively. Wheals, which resolved without intervention or long-term sequelae, were reported for 3 patients. Conclusions: To the authors’ knowledge, this is the largest clinical study of the effectiveness of the Ulthera System for rejuvenation of the lower face. At day 90, improvements were reported by two-thirds of patients and by nearly 60% of blinded reviewers. Outcomes were better in patients with BMI ≤30 kg/m2. Level of Evidence: 2
Article
Microfocused ultrasound (MFU) is an effective means for tightening and lifting lax facial and neck skin. To evaluate the safety and efficacy of MFU with visualization (MFU-V) for noninvasive treatment of facial and neck skin laxity 180 days after treatment and determine what lifestyle factors affect treatment outcomes. Healthy women (N = 48) previously treated with MFU-V on the face and upper neck were enrolled. Depending on when MFU-V treatment occurred, subjects completed 90- or 180-day follow-up visits or both. Digital images of each subject were obtained before treatment and at follow-up visits. Data were obtained at 90 (N = 16) and 180 days (N = 45), and physician Global Aesthetic Improvement Scale (GAIS) scores demonstrated that 81.3% and 77.7% patients achieved improvement, respectively. At 90 and 180 days, subject GAIS scores showed 75% and 77.8% of subjects perceived improvement, respectively. At 180 days, blinded reviewer assessments indicated that 67% of subjects showed improvement in appearance. There was no association between improvement and age, Fitzpatrick skin type, alcohol intake, or major illness. One minor adverse event was reported. Although the data obtained at 90 days must be interpreted cautiously because of the smaller number of patients, subjects achieved significant lifting and tightening of facial and neck skin up to 180 days after one MFU treatment.
Article
Ultrasound skin tightening is a noninvasive, nonablative method that allows for energy deposition into the deep dermal and subcutaneous tissue while avoiding epidermal heating. Ultrasound coagulation is confined to arrays of 1-mm(3) zones that include the superficial musculoaponeurotic system and connective tissue. This technology gained approval from the Food and Drug Administration as the first energy-based skin "lifting" device, specifically for lifting lax tissue on the neck, submentum, and eyebrows. Ultrasound has the unique advantage of direct visualization of treated structures during treatment. Ultrasound is a safe and efficacious treatment for mild skin tightening and lifting.
Article
Background: There is an emerging perspective that it is not sufficient to just assess skin exposure to physical and chemical stressors in workplaces, but that it is also important to assess the condition, i.e. skin barrier function of the exposed skin at the time of exposure. The workplace environment, representing a non-clinical environment, can be highly variable and difficult to control, thereby presenting unique measurement challenges not typically encountered in clinical settings. Methods: An expert working group convened a workshop as part of the 5th International Conference on Occupational and Environmental Exposure of Skin to Chemicals (OEESC) to develop basic guidelines and best practices (based on existing clinical guidelines, published data, and own experiences) for the in vivo measurement of transepidermal water loss (TEWL) and skin hydration in non-clinical settings with specific reference to the workplace as a worst-case scenario. Results: Key elements of these guidelines are: (i) to minimize or recognize, to the extent feasible, the influences of relevant endogenous-, exogenous-, environmental- and measurement/instrumentation-related factors; (ii) to measure TEWL with a closed-chamber type instrument; (iii) report results as a difference or percent change (rather than absolute values); and (iv) accurately report any notable deviations from this guidelines. Conclusion: It is anticipated that these guidelines will promote consistent data reporting, which will facilitate inter-comparison of study results.