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Accepted: 2 November 2017

DOI: 10.1111/jocd.12466

ORIGINAL CONTRIBUTION

Immediate effect and safety of HIFU single treatment for


male subcutaneous fat reduction

Fernanda Guth BS1 | Shanna Bitencourt PhD2 | Cıcero Bedinot MS3 |


Giovana Sinigaglia MS1 | Jo~
ao Alberto Fioravante Tassinary PhD1

1
Centro de Cie^ncias Biolo
gicas e da Sa
ude,
Universidade do Vale do Taquari (Univates), Summary
Lajeado, RS, Brazil Background: The increasing search for procedures for fat reduction is related to
2
Laboratorio de Cultura de Celulas,
s-graduacß~
dissatisfaction with body shape. High-intensity focused ultrasound (HIFU) has been
Programa de Po ao em
Biotecnologia, Universidade do Vale do proven effective in body sculpting when used noninvasively to reduce subcutaneous
Taquari (Univates), Lajeado, RS, Brazil
fat and improve body contour.
3
Instituto Innovate, Caxias do Sul, RS, Brazil
Aims: This study aimed to evaluate the immediate effect and safety of HIFU single
Correspondence treatment for male localized fat and body remodeling.
Shanna Bitencourt, Programa de Po s-
graduacß~ao em Biotecnologia, Univates, Patients/Methods: Twenty-four male subjects (18 to 59 years old) with
Lajeado, RS, Brazil. BMI ≤ 30 kg/cm² and at least 2 cm of abdominal fat received a single HIFU treat-
Email: shanna.lab@gmail.com
ment session. Individuals were subjected to abdominal measurements before and
Funding information after procedure. In addition, biochemical analyses of blood samples were performed
Coordenacß~ao de Aperfeicßoamento de
Pessoal de Nıvel Superior (Capes) to assess possible inflammatory effects or oxidative stress induction by the treat-
ment.
Results: High-intensity focused ultrasound was found to be an effective treatment
in reducing localized adiposities in the abdominal region. A significant decrease
(0.6%) was observed in infraumbilical circumference of subjects submitted to HIFU
single treatment when compared with control subjects. The laboratory parameters
did not present any appreciable changes.
Conclusion: This study further strengthens the current view that HIFU is an effec-
tive and safe tool for localized fat reduction.

KEYWORDS
adipocytes, body contouring, localized fat

1 | INTRODUCTION High-intensity focused ultrasound (HIFU) has been proven effec-


tive when used noninvasively to reduce fat and to improve body con-
There is a growing search for subcutaneous fat reduction for body tours.3 The thermal effect causes increased local temperature
contouring allied to the pursuit of health. For years, liposuction was generating coagulation and necrosis of adipocytes. The nonthermal
the only accepted treatment for body contouring, however, like any effect creates the rupture of adipocytes and promotes the removal of
other surgery procedure is not without complications. For that rea- lipids. Both effects occur without causing damage to adjacent tissues.4
son, the number of noninvasive methods to remove unwanted fat Most lipids and cellular debris are removed within 12 weeks after the
has grown significantly. Several methods using focused energy procedure, with 95% remove within 18 weeks, which results in an
devices such as laser, radiofrequency, ultrasound and cryolipolysis overall reduction in the volume of adipose tissue treated areas.5
have the principle of selectively damage fat tissue through apoptosis Currently, there is no consensus about the exposure parameters
or necrosis induction of fat cells.1,2 used clinically. Time exposure, dose, frequency and ultrasonic wave

J Cosmet Dermatol. 2017;1–5. wileyonlinelibrary.com/journal/jocd © 2017 Wiley Periodicals, Inc. | 1


2 | GUTH ET AL.

pulse duration are not well defined, besides mechanism of action not cholesterol, high-density lipoprotein [HDL], low-density lipoprotein
clearly understood.6,7 As the thermal effect of HIFU can result in [LDL], very low-density lipoprotein [VLDL], triglyceride); hepatic,
adipocyte necrosis in the treatment area, it is important to evaluate pancreatic and renal function (alanine transaminase [ALT], aspartate
safety of HIFU to confirm the lack of significant adverse reactions. 7
aminotransferase [AST], c-glutamyl transpeptidase [GGT], albumin,
This study was designed to evaluate the immediate effect and safety lipase, creatine phosphokinase [CK]); lactic dehydrogenase [LDH];
of HIFU clinical use for the treatment of localized fat and body C-reactive protein [CRP]; hematology and coagulation profiles.
remodeling in male subjects.

2.6 | Lipid peroxidation and nitrite assays


2 | MATERIAL AND METHODS
Lipid peroxide content was assayed with xylenol orange as previously
described.8 Total nitrite (nitrate + nitrite) concentration was measured
2.1 | Ex vivo thermal evaluation of HIFU
with the Griess reagent and nitrate reductase activity.9 Absorbance
Thermal analysis following treatment was performed on 10-mm-thick was determined at 540 nm with an ELISA microplate reader.
porcine abdominal adipose tissue with preserved dermis and epidermis
using a FLIR I60 infrared camera (FLIR system Inc., USA). The Dual
2.7 | Statistical analysis
SOONTM HIFU device (Tonedermâ, Brazil) was used with a standard
ultrasonic gel smeared on the skin before treatment to achieve ade- The percentages of treated and control groups were compared and
quate acoustic contact. Settings were as follows: 57 W power output, expressed as mean  SEM. The Shapiro-Wilk test was used to
pulsed mode (20 cycles of 6 seconds), 3 MHz frequency. The cooled assess normality. For the parameters comparing two groups, it was
transducer was imaged to check the initial temperature of the device, used the Student’s t test. In all cases, the results were considered
then, at the focal point after a single pass and right after 20 cycles. statistically significant when P < .05. All analyzes were performed
using SPSS (Statistical Package for Social Sciences) version 18.0 (Chi-
cago, IL, USA).
2.2 | Patients and treatment details
This prospective pilot clinical before-after study was approved by
the Ethics Research Committee of Universidade do Vale do Taquari 3 | RESULTS
(protocol # 018925/2016). All volunteers signed an informed con-
sent. Twenty-four male subjects between the ages of 18 and We started our study analyzing the focal temperature rise induced
59 years with BMI ≤ 30 kg/cm² and at least 2 cm of abdominal fat by HIFU exposure on porcine abdominal adipose tissue. As depicted
were randomly selected for this study. Subjects were divided into in Figure 1, the initial temperature of the treated area measured
two groups: control (n = 12) and treated (n = 12). with a thermal camera was 14.5°C~16.5°C. After 20 cycles, the tem-
perature of the focal intra-dermal area was measured and the aver-
age obtained was 47.9°C  4.2°C, which was about 33.4°C higher
2.3 | High-intensity focused ultrasound lipolysis
than initial temperature. The average temperature rise in the tissue
A single HIFU treatment session was performed. A stencil was used to surface was 9.2°C  1.5°C.
mark the treatment region in the infra-abdominal area. The subjects Abdominal measurements of individuals that underwent 30 min-
TM
were placed supine and the therapy was applied using Dual SOON utes HIFU treatment were evaluated. As shown in Figure 2A, the
device delivering 3 MHz, 57 W of power for 6 seconds with 2-second percentage difference of abdominal circumference of supraumbilical
interval at each area. Control group did not receive HIFU treatment. and umbilical areas had no significant difference between treated
and control groups. However, a significant decrease of 0.6%
(P < .05) was verified in the measurement of infraumbilical circum-
2.4 | Body measurements
ference of subjects submitted to HIFU treatment. In addition, thick-
Thickness of subcutaneous abdominal fat on both sides was first ness of subcutaneous fat on the right and left abdomen remained
assessed by a spring-loaded skinfold calipers. Abdominal circumfer- unchanged after HIFU application (Figure 2B).
ence measurements on the umbilicus, 5 cm above and 5 cm below According to Table 1, the results of lipid panel showed overall
it, were taken before and 30 minutes after treatment. To normalize stable levels of total cholesterol, HDL, LDL, VLDL and triglycerides
individual differences, data were expressed as percent changes over with no statistical differences between control and treated groups.
the initial measures. There were no substantive differences between the study groups for
the parameters of liver, kidney and pancreatic functions. In addition,
there was no significant alteration on serum levels of the inflamma-
2.5 | Laboratory parameters
tory marker CRP (Table 1) and erythrocyte sedimentation rate, leu-
Blood samples were obtained at baseline and 30 minutes after treat- kocytes, monocytes, lymphocytes percentage. However, there was a
ment. Samples were used to analyze lipid panel values (total 25% increase in the number of segmented neutrophils, and a
GUTH ET AL. | 3

(A) (B) (C)

F I G U R E 1 Surface temperature changes of the porcine model during application of High-intensity focused ultrasound (HIFU). A, Cooled
ultrasound transducer. B, Initial measurement of adipose tissue during HIFU application. C, Measurement immediately after HIFU application.
HIFU delivered heat intensively only to the subcutaneous fat layer of the focal area and did not affect surrounding skin tissue

F I G U R E 2 Percentage difference of abdominal measurements 30 minutes after High-intensity focused ultrasound (HIFU) treatment.
A, Abdominal circumference of supraumbilical, umbilical and infraumbilical areas. B, Thickness of subcutaneous fat on the right and left
abdomen. Data are expressed as mean  SEM (n = 12). *P < .05

consequent increase of granulocytes (6.2%) in the group of indivi- temperature raise of 27°C of porcine adipose tissue without causing
duals who received HIFU treatment when compared with the group damage to adjacent tissues. These data are in keeping with those of
that did not receive treatment (data not shown). previous in vivo porcine studies, in which HIFU was shown to cause
selective adipose cell reduction without injury to skin.10,11 Based on
these data, we decided to use the same HIFU parameters for appli-
4 | DISCUSSION cation on male subjects.
To verify possible immediate effects of HIFU treatment with
Porcine skin and subcutaneous tissue closely resemble human tissue regard to the anthropometric measurements of the treated area,
with respect to morphological and physiological properties making it abdominal circumference and skinfold were performed. Although
a reliable model.10 In this sense, we initially evaluated ex vivo the there was no significant difference in skinfold and abdominal circum-
temperature at the local area of application of HIFU in swine tissue. ference of supraumbilical and umbilical areas, there was a 0.6%
Our findings showed that Dual SOONTM HIFU device reached a decrease in infraumbilical circumference. It is noteworthy that this
4 | GUTH ET AL.

T A B L E 1 The effects of High-intensity


Control HIFU
focused ultrasound (HIFU) on serum
Before After Before After biochemical parameters 30 minutes after
Total cholesterol (mg/dL) 192.0  12.2 191.2  11.9 194.4  10.7 193.6  11.3 a single treatment
HDL (mg/dL) 54.8  4.1 55.6  4.0 47.4  1.5 47.5  1.6
LDL (mg/dL) 114.8  11.9 113.8  11.4 117.1  7.6 117.8  8.4
VLDL (mg/dL) 22.7  3.1 21.9  2.6 29.9  5.0 28.1  5.1
Triglycerides (mg/dL) 111.7  14.2 109.9  13.1 149.5  25.0 141.1  25.3
CRP (mg/dL) 1.6  0.2 1.6  0.2 1.2  0.4 1.1  0.4
Lipase (IU/mL) 42.8  5.6 44.7  4.6 44.0  7.3 39.2  6.4
CK (mg/dL) 119.1  20.6 122.8  20.3 224.9  48.9 217.0  47.2
Albumin (mg/dL) 4.4  0.1 4.4  0.1 4.6  0.1 4.6  0.1
AST (IU/L) 21.0  2.1 20.2  1.7 24.6  1.3 23.1  1.2
ALT (IU/L) 19.1  2.5 19.5  2.7 21.0  2.9 22.3  2.8
GGT (IU/L) 27.4  2.8 30.9  5.5 33.1  5.4* 34.1  5.6*
LDH (IU/L) 268.0  19.4 263.3  10.2 302.2  18.2 295.3  12.7

HDL, High-density lipoprotein; LDL, low-density lipoprotein; VLDL, very low-density lipoprotein; CRP,
C-reactive protein; CK, creatine phosphokinase; AST, aspartate aminotransferase; ALT, alanine transami-
nase; GGT, c-glutamyl transpeptidase; LDH, lactic dehydrogenase.
Data are expressed as mean  SEM.
*P < .05.

region is the area of greater fat deposit and the one that received subjects. Although the limitation of the present study includes the
most of HIFU application compared with other abdomen regions. lack of histological assessment and a longer follow up period, it fur-
Previous studies using other methodological parameters demon- ther strengthens the current view that HIFU is an effective and safe
strated that the reduction in circumference happens even 3 months tool for liporeductive purposes in the abdominal region.
after HIFU application. Fatemi5 reported that 282 patients who
underwent a single HIFU treatment on the abdomen and flanks
ACKNOWLEDGMENT
showed an average reduction of 4.7 cm in waist circumference after
3 months. In addition, Teitelbaum, Burns12 reported a mean reduc- This work was supported by a Postdoc Grant from Coordenacß~ao de
tion of approximately 2 cm in abdomen, thighs or flanks circumfer- Aperfeicßoamento de Pessoal de Nıvel Superior (Capes) awarded to
ence and approximately 2.9 mm in skin fat thickness in 137 healthy Shanna Bitencourt.
subjects within 2 weeks and sustained at 12 weeks after a single
HIFU treatment.
ORCID
According to previous studies, when raising the temperature of
adipose tissue above 58°C, HIFU can promote the death of adipo- Shanna Bitencourt http://orcid.org/0000-0002-5854-1550
cytes by heating without affecting adjacent tissue.13 In the search Giovana Sinigaglia http://orcid.org/0000-0002-4614-3272
for the physiological responses that can lead to improvement of the
body contour without harming, we assessed biochemical markers.
Our results demonstrated that under the experimental conditions, REFERENCES
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