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12/06/2019

Immediate effect and safety of HIFU single treatment for male subcutaneous fat reduction

Immediate effect and safety of HIFU single treatment for male subcutaneous fat reduction

Accepted: 2 November 2017

DOI: 10.1111/jocd.12466

O R I G I N A L C O N T R I B U T I O N

 

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

1Centro de Ciencias^ Biologicas e da Saude, Universidade do Vale do Taquari (Univates), Lajeado, RS, Brazil

2Laboratorio de Cultura de Celulas, Programa de Pos-graduac~ao em Biotecnologia, Universidade do Vale do Taquari (Univates), Lajeado, RS, Brazil

3Instituto Innovate, Caxias do Sul, RS, Brazil

Correspondence

Shanna Bitencourt, Programa de Pos-graduac~ao em Biotecnologia, Univates, Lajeado, RS, Brazil.

Email: shanna.lab@gmail.com

Funding information

Cordenac~ao de Aperfeicoamento de Pessoal de Nıvel Superior (Capes)

 

 

Summary

 

 

Background: The increasing search for procedures for fat reduction is related to dissatisfaction with body shape. High-intensity focused ultrasound (HIFU) has been proven effective in body sculpting when used noninvasively to reduce subcutaneous fat and improve body contour.

 

Aims: This study aimed to evaluate the immediate effect and safety of HIFU single treatment for male localized fat and body remodeling.

 

Patients/Methods: Twenty-four male subjects (18 to 59 years old) with BMI ≤ 30 kg/cm² and at least 2 cm of abdominal fat received a single HIFU treat-ment session. Individuals were subjected to abdominal measurements before and after procedure. In addition, biochemical analyses of blood samples were performed 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.

 

K E Y W O R D S

 

adipocytes, body contouring, localized fat

 

 

 

1    |    I N T R O D U C T I O N

 

There is a growing search for subcutaneous fat reduction for body contouring allied to the pursuit of health. For years, liposuction was the only accepted treatment for body contouring, however, like any other surgery procedure is not without complications. For that rea-son, the number of noninvasive methods to remove unwanted fat has grown significantly. Several methods using focused energy devices such as laser, radiofrequency, ultrasound and cryolipolysis have the principle of selectively damage fat tissue through apoptosis or necrosis induction of fat cells.1,2

High-intensity focused ultrasound (HIFU) has been proven effec-tive when used noninvasively to reduce fat and to improve body con-tours.3 The thermal effect causes increased local temperature generating coagulation and necrosis of adipocytes. The nonthermal effect creates the rupture of adipocytes and promotes the removal of lipids. Both effects occur without causing damage to adjacent tissues.4 Most lipids and cellular debris are removed within 12 weeks after the procedure, with 95% remove within 18 weeks, which results in an overall reduction in the volume of adipose tissue treated areas.5

Currently, there is no consensus about the exposure parameters 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 clearly understood.6,7 As the thermal effect of HIFU can result in adipocyte necrosis in the treatment area, it is important to evaluate safety of HIFU to confirm the lack of significant adverse reactions.7 This study was designed to evaluate the immediate effect and safety of HIFU clinical use for the treatment of localized fat and body remodeling in male subjects.

cholesterol, high-density lipoprotein [HDL], low-density lipoprotein [LDL], very low-density lipoprotein [VLDL], triglyceride); hepatic, pancreatic and renal function (alanine transaminase [ALT], aspartate aminotransferase [AST], c-glutamyl transpeptidase [GGT], albumin, lipase, creatine phosphokinase [CK]); lactic dehydrogenase [LDH]; C-reactive protein [CRP]; hematology and coagulation profiles.

 

2    |    M A T E R I A L A N D M E T H O D S

 

2.1    |    Ex vivo thermal evaluation of HIFU

Termal analysis following treatment was performed on 10-mm-thick porcine abdominal adipose tissue with preserved dermis and epidermis using a FLIR I60 infrared camera (FLIR system Inc., USA). The Dual SOONTM HIFU device (Tonederm , Brazil) was used with a standard ultrasonic gel smeared on the skin before treatment to achieve ade-quate acoustic contact. Settings were as follows: 57 W power output, pulsed mode (20 cycles of 6 seconds), 3 MHz frequency. The cooled transducer was imaged to check the initial temperature of the device, then, at the focal point after a single pass and right after 20 cycles.

 

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 (protocol # 018925/2016). All volunteers signed an informed con-sent. Twenty-four male subjects between the ages of 18 and 59 years with BMI ≤ 30 kg/cm² and at least 2 cm of abdominal fat were randomly selected for this study. Subjects were divided into two groups: control (n = 12) and treated (n = 12).

 

2.3    |    High-intensity focused ultrasound lipolysis

A single HIFU treatment session was performed. A stencil was used to mark the treatment region in the infra-abdominal area. The subjects were placed supine and the therapy was applied using Dual SOONTM device delivering 3 MHz, 57 W of power for 6 seconds with 2-second interval at each area. Control group did not receive HIFU treatment.

 

2.4    |    Body measurements

Thickness of subcutaneous abdominal fat on both sides was first assessed by a spring-loaded skinfold calipers. Abdominal circumfer-ence measurements on the umbilicus, 5 cm above and 5 cm below it, were taken before and 30 minutes after treatment. To normalize individual differences, data were expressed as percent changes over the initial measures.

 

2.5    |    Laboratory parameters

Blood samples were obtained at baseline and 30 minutes after treat-ment. Samples were used to analyze lipid panel values (total

 

2.6   |    Lipid peroxidation and nitrite assays

Lipid peroxide content was assayed with xylenol orange as previously described.8 Total nitrite (nitrate + nitrite) concentration was measured with the Griess reagent and nitrate reductase activity.9 Absorbance was determined at 540 nm with an ELISA microplate reader.

 

2.7   |    Statistical analysis

The percentages of treated and control groups were compared and expressed as mean SEM. The Shapiro-Wilk test was used to assess normality. For the parameters comparing two groups, it was used the Student’s t test. In all cases, the results were considered statistically significant when P < .05. All analyzes were performed using SPSS (Statistical Package for Social Sciences) version 18.0 (Chi-cago, IL, USA).

 

 

3    |    R E S U L T S

We started our study analyzing the focal temperature rise induced by HIFU exposure on porcine abdominal adipose tissue. As depicted in Figure 1, the initial temperature of the treated area measured 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 than initial temperature. The average temperature rise in the tissue surface was 9.2°C 1.5°C.

Abdominal measurements of individuals that underwent 30 min-utes HIFU treatment were evaluated. As shown in Figure 2A, the percentage difference of abdominal circumference of supraumbilical 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-ference of subjects submitted to HIFU treatment. In addition, thick-ness of subcutaneous fat on the right and left abdomen remained unchanged after HIFU application (Figure 2B).

According to Table 1, the results of lipid panel showed overall stable levels of total cholesterol, HDL, LDL, VLDL and triglycerides with no statistical differences between control and treated groups. 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-tory marker CRP (Table 1) and erythrocyte sedimentation rate, leu-kocytes, monocytes, lymphocytes percentage. However, there was a 25% increase in the number of segmented neutrophils, and a

 

GUTH ET AL.

 

 

 

|   3

 

 

 

 

 

(B)

 

 

 

 

 

 

(A)

(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

|  D I S C U S S I O N

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   |                                                

 

 

 

Control

 

 

HIFU

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Before

After

 

Before

After

 

 

 

 

 

 

 

 

 

 

Total cholesterol (mg/dL)

192.0

12.2

191.2

11.9

194.4

10.7

193.6

11.3

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

                     


 

 

T A B L E 1 The effects of High-intensity focused ultrasound (HIFU) on serum biochemical parameters 30 minutes after a single treatment

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.

region is the area of greater fat deposit and the one that received most of HIFU application compared with other abdomen regions. Previous studies using other methodological parameters demon-strated that the reduction in circumference happens even 3 months after HIFU application. Fatemi5 reported that 282 patients who underwent a single HIFU treatment on the abdomen and flanks showed an average reduction of 4.7 cm in waist circumference after 3 months. In addition, Teitelbaum, Burns12 reported a mean reduc-tion of approximately 2 cm in abdomen, thighs or flanks circumfer-ence and approximately 2.9 mm in skin fat thickness in 137 healthy subjects within 2 weeks and sustained at 12 weeks after a single HIFU treatment.

 

According to previous studies, when raising the temperature of adipose tissue above 58°C, HIFU can promote the death of adipo-cytes by heating without affecting adjacent tissue.13 In the search 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, HIFU did not promote clinically meaningful changes in findings on lipid panel or liver, pancreas and kidney functions. About the increase in neutrophils and total granulocyte counting, we can assume that this is given the mechanism of action of HIFU, whereby lesion formation is followed by a normal healing process, in which macrophages and neutrophils are attracted to remove lipids and cell debris.3,7

 

5    |    C O N CL U S I O N

This study evaluated the effects and safety of HIFU within 30 min-utes after a single treatment for subcutaneous fat reduction in male subjects. Although the limitation of the present study includes the ack of histological assessment and a longer follow up period, it fur-ther strengthens the current view that HIFU is an effective and safetool for liporeductive purposes in the abdominal region.

 

A C K N O W L E D G M E N T

 

This work was supported by a Postdoc Grant from Coordenac~ao de Aperfeicoamento de Pessoal de Nıvel Superior (Capes) awarded to

Shanna Bitencourt.

 

O R C I D

Shanna Bitencourt  http://orcid.org/0000-0002-5854-1550 Giovana Sinigaglia  http://orcid.org/0000-0002-4614-3272

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  1. Mulholland RS, Paul MD, Chalfoun C. Noninvasive body contouring with radiofrequency, ultrasound, cryolipolysis, and low-level laser therapy. Clin Plast Surg. 2011;38:503-520.

 

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  1. Fatemi A, Kane MA. High-intensity focused ultrasound effectively reduces waist circumference by ablating adipose tissue from the abdomen and flanks: a retrospective case series. Aesthetic Plast Surg. 2010;34:577-582.

 

  1. Fatemi A. High-intensity focused ultrasound effectively reduces adi-pose tissue. Semin Cutan Med Surg. 2009;28:257-262.

 

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How to cite this article: Guth F, Bitencourt S, Bedinot C, Sinigaglia G, Tassinary JAF. Immediate effect and safety of HIFU single treatment for male subcutaneous fat reduction. J Cosmet Dermatol. 2017;00:1–5. https://doi.org/10.1111/ jocd.12466