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Efficacy and safety of non-invasive body tightening with high-intensity

focused ultrasound (HIFU)

Article in Skin Research and Technology · May 2017

DOI: 10.1111/srt.12371

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Accepted: 12 April 2017

DOI: 10.1111/srt.12371

ORIGINAL ARTICLE

Efficacy and safety of non-­invasive body tightening with

high-­intensity focused ultrasound (HIFU)

E. J. Ko1,2 | J. Y. Hong1 | T.-R. Kwon1 | E. J. Choi1 | Y.-J. Jang1,3 | S. Y. Choi1,4 |

K. H. Yoo5 | S. Y. Kim6 | B. J. Kim1

1
Department of Dermatology, Chung-Ang
University College of Medicine, Seoul, South Abstract
Korea Background: Noninvasive skin-­tightening devices have become increasingly popular
2
Department of Dermatology, Myongji
in response to increasing demand for improvements in skin laxity and tightening with
Hospital, Seonam University College of
Medicine, Goyang, Korea minimal risk and recovery time.
3
Department of Medicine, Graduate School, Objective: We evaluated the efficacy and safety of HIFU for skin tightening in the face
Chung-Ang University, Seoul, Korea
and body.
4
Department of Dermatology, Seoul Paik
Hospital, Inje University College of Medicine, Methods: A total of 32 Korean subjects enrolled in this prospective clinical trial. The
Seoul, Korea subjects were treated with HIFU to both cheeks, lower abdomen, and thigh. Skin elas-
5
Department of Dermatology, College of ticity was measured before and after treatment using a Cutometer (CT575, Courage
Medicine, Catholic Kwandong University,
International St. Mary’s Hospital, Incheon, and Khazaka®, Cologne, Germany). Three blinded, experienced dermatologists evalu-
Korea ated paired pre-­and post-­treatment (week 4 and 12) photographs according to the
6
Classys Inc., Seoul, Korea
Global Aesthetic Improvement Scale (GAIS). Participants also completed self-­
Correspondence assessments using GAIS. Subjects rated their pain on a numeric rating scale (NRS) im-
Beom Joon Kim, Department of Dermatology,
mediately, 7 days, 4 weeks, and 12 weeks after treatment.
Chung Ang University Hospital, 224-1
Heukseok-dong, Dongjak-ku, Seoul 156-755, Results: Skin elasticity measured via a Cutometer was significantly improved 12 weeks
South Korea.
after treatment at all treated sites (P<.05). Both IGAIS and SGAIS showed significant
Email: [email protected]
improvements 12 weeks after treatment. Immediately after treatment the mean NRS
score was 3.00±1.586, but no pain was reported at 4 and 12 weeks post-­treatment.
No serious adverse effects were observed during the follow-­up period.
Conclusion: HIFU safely and effectively improves skin elasticity and clinical contour-
ing of the face and body.

KEYWORDS
body tightening, high-intensity focused ultrasound

1 | INTRODUCTION body laxity. Radiofrequency and infrared laser devices which expose
the dermis to controlled heat and stimulate neocollagenesis in der-
The most common features of aging skin are laxity and loss of elas- mis have inferior efficacy so that surgery still remains the treatment
ticity. As the skin ages, elastic fiber, collagen, and connective tissue of choice in moderate to severe tissue laxity.1 Although surgical face
in the dermis are reduced. Skin moisture and subcutaneous fat also lifting is the most effective treatment to improve skin laxity, it is also
decrease. There are many procedures to improve skin laxity, such as a procedure that involves risks such as scarring, infection, nerve dam-
laser therapy, radiofrequency, botulinum toxin, fat autografts, and sur- age, inherent risks of anesthesia, swelling, and bruising.2
gical lifting. Of these procedures, botulinum toxin and fat autografts HIFU technology was originally used as a non-­invasive modality
are used for facial rejuvenation but are difficult to apply for improving for selectively destroying tumor cells of internal organs by thermal

Skin Res Technol. 2017;1–5. wileyonlinelibrary.com/journal/srt © 2017 John Wiley & Sons A/S. | 1
Published by John Wiley & Sons Ltd
2 | KO et al.

coagulative necrosis for many decades.3 HIFU was recently intro- depth), and four newly developed transducers for body skin tighten-
duced as a new treatment modality for skin tightening and rejuvena- ing (MF3: 2-­MHz, 3.0-­mm focal depth, MF4: 2-­MHz, 4.5-­mm focal
tion. The mechanism of HIFU is transcutaneous heat delivery to the depth, MF6: 2-­MHz, 6.0-­mm focal depth and MF9: 2-­MHz, 9.0-­mm
deep dermis, subdermal connective tissue, and fibromuscular layer focal depth). Ultrasound gel was applied to the treated area and the
in precise microcoagulation zones at consistent programmed depths transducer of HIFU was pressed perpendicularly, uniformly, and firmly
without damage to the epidermis. This microcoagulation is thought to to the skin surface (Figure 2). Treatment exposure was initiated with a
cause gradual tightening of the skin through collagen contraction and line of individual ultrasound pulses. The pulse duration for each indi-
remodeling.4 HIFU first received approval for eyebrow lifting, but der- vidual exposure ranged from 25 to 40 milliseconds. The 25-­mm-­long
matologists are using the technology for many off-­label applications, exposure lines of ultrasound pulses were manually delivered adjacent
such as facial rejuvenation, skin whitening, and lipolysis. and parallel to one another approximately 3–5 mm apart. We treated
HIFU has been used safely and effectively to treat facial and neck subjects with several types of transducers appropriate to the thick-
skin in a variety of skin types, but some studies have examined its use nesses of facial and body skin. Three transducers (MF1, 3, and 4) were
for the body, including our pilot study.5–7 In this study, we sought to applied to the face and all five transducers (MF1, 3, 4, 6, and 9) were
determine the clinical efficacy and safety of HIFU with novel transduc- applied to the body. The energy per ultrasound pulse ranged from 1.0
ers in both face and body regions. to 1.5 J. When patients reported feeling pain, we reduced exposures
to 0.1–0.3 J per time, and did not increase exposures up to 1.5 J. The

2 | SUBJECTS AND METHODS

Korean patients with skin laxity on the face, abdomen, and thigh were
recruited for study entry. The study was approved by the Institutional
Review Board of Chung-­Ang University Hospital. Informed consent
was obtained from all patients. Exclusion criteria were prior cosmetic
or surgical treatments (eg, laser, RF, surgical lifting, filler injections),
skin infection or inflammation, pregnancy, skin diseases that may alter
wound healing, open wounds, and scarring over the treatment area.
For pre-­treatment preparation, we applied topical anesthetic cream
to all treated areas including both cheeks, the lower abdomen, and
the posterior thigh. The sizes of the involved areas were 5.0 × 5.0 cm2
on each cheek and 7.5 × 7.5 cm2 on each lower abdomen and thigh
(Figure 1). We used a HIFU device (ULTRAFORMER III (SHURINK)
F I G U R E 2 The ULTRAFORMER III (SHURINK) HIFU device MF9
CLASSYS INC., Seoul, Korea) with five different transducers: one (2 MHz, 9.0 mm) tip applied on the abdomen (obtained from Classys
basic transducer for facial skin tightening (MF1: 7-­MHz, 1.5-­mm focal Inc., with permission)

FIGURE 1 Face and body treatment

areas
KO et al. | 3

treatment lines included a total of 120 shots for the cheek, distributing all treated areas (Figure 3). The change of the mean R7 value at the
a total 537.6 J, and 450 shots for the abdomen and thigh, distributing thigh was 0.054±0.032, which represented the greatest change among
a total 900 J. The time required for complete HIFU treatment of the the treated areas. IGAIS scores also showed good results (Table 1).
face and body was over 40 minutes. Of the three treated areas, the cheek demonstrated the greatest im-
All patients were followed up at 4 and 12 weeks after treatment, provements after treatment. At 4 weeks post-­treatment, the improve-
at which times we obtained clinical photographs using consistent pa- ment rates of subjects who were assessed as either improved (IGAIS
tient positioning, camera settings (Canon EOS 600D, high-­resolution score 1) or much improved (IGAIS score 2) were 96.9%, 84.4%, and
setting, 5760 × 3840 pixels, Canon Inc., Tokyo, Japan), and room 78.1% on the cheek, abdomen, and thigh respectively. At 12 weeks
lighting. Baseline and post-­
treatment photographs were randomly post-­treatment, the improvement rate of the cheek area was reduced
displayed, and independently evaluated by three dermatologists who to 90.6%, but the body areas did not change significantly. Most sub-
were masked to the study protocol. Investigator Global Aesthetic jects were satisfied with the results of treatment (Table 2). At 4 weeks
Improvement Scale (IGAIS) scores were determined using side-­by-­ post-­treatment, all subjects rated SGAIS scores as greater than 1 on
side comparisons of 4-­and 12-­
week post-­
treatment photographs the cheek and thigh. The improvement rate assessed for the abdomen
to baseline. The subjects also evaluated the tightening effects using as greater than SGAIS 1 was 93.8%. At 12 weeks post-­treatment, the
the Subject Global Aesthetic Improvement Scale (SGAIS) at 4 and improvement rates of cheek and thigh were reduced from 100% to
12 weeks post-­treatment. We used the Cutometer (Courage+Khazaka 96.9%. However, the improvement rate of the abdomen increased to
Electronic GmbH, Cologne, Germany) to measure skin elasticity and 96.8%.
objectively evaluate skin tightening. Among the cutometer-­specific R
values (R0–R9), the R7 value is the ratio of elastic recovery to the total
deformation and represents biological elasticity. Adverse effects were TABLE 1 Investigator Global Aesthetic Improvement Scale
(IGAIS)
assessed at each visit after treatment. A numeric rating scale (NRS)
was used to score pain immediately, 7 days, 4 weeks, and 12 weeks IGAIS
after the application of HIFU.
0 1 2 3

Cheek
2.1 | Statistical analyses Post-­treatment n 1 29 2 0
(4W) % 3.1 90.6 6.3 0
Statistical analyses were performed using SPSS version 21.0 for
Windows (SPSS Inc., Chicago, IL, USA) and R version 3.2.3 (2015-­12-­ Post-­treatment n 3 29 0 0
10). We used Hochberg step-­up methods to adjust values for multiple (12W) % 9.4 90.6 0 0
comparisons. Statistical comparisons before and after treatments were Abdomen
performed using paired t tests. Data are presented as mean±standard Post-­treatment n 5 27 0 0
deviation. P values <.05 were considered statistically significant. (4W) % 15.6 84.4 0 0
Post-­treatment n 5 26 1 0
(12W)
3 | RESULTS % 15.6 81.3 3.1 0
Thigh
3.1 | Efficacy Post-­treatment n 7 25 0 0
(4W) % 21.9 78.1 0 0
This study included 32 Korean patients (29 females and 3 males), aged
21–59 (mean±SD: 44.47±9.73) with Fitzpatrick skin types III and IV. Post-­treatment n 7 25 0 0
(12W) % 21.9 78.1 0 0
All patients completed the 3-­month study.
The mean R7 value according to the Cutometer was significantly 0=No change, 1=Mild improvement, 2=Moderate improvement,
increased at 4 and 12 weeks post-­treatment compared to baseline in 3=Significant improvement.

*** ***
0.6

*** ***
0.5
0.4
Cutometer_R7

*** ***
Time
0.3

Before
0.2

After 4 weeks
After 12 weeks
0.1

‘***’ : Significant differences;

F I G U R E 3 Mean pre-­and post-­
0.0

P < 0.001 versus before by

Cheeks Abdomen Thigh
treatment R7 values of skin elasticity paired-samples t-test
measured using Cutometers Cutometer (R7) test
4 | KO et al.

TABLE 2 Subject Global Aesthetic Improvement Scale (SGAIS) ecchymosis had resolved. We observed no serious or delayed adverse
effects during the follow-­up period.
SGAIS

0 1 2 3

Cheek 4 | DISCUSSION
Post-­treatment n 0 13 13 6
(4W) % 0 40.6 40.6 18.8 There are many noninvasive options of body sculpting, such as radiof-
requency ablation, cryolipolysis, injection lipolysis, external low-­level
Post-­treatment n 1 10 13 8
(12W) lasers, laser ablation, nonthermal ultrasound, and HIFU. Each of these
% 3.1 31.3 40.6 25
treatments has no admission for treatment without anesthesia or an-
Abdomen
algesia and typically fewer complications than liposuction. However,
Post-­treatment n 2 15 11 4
with the exception of HIFU, patients have to visit the hospital several
(4W) % 6.3 46.9 34.4 12.5
times for multiple treatments to achieve meaningful. Injection lipolysis
Post-­treatment n 1 13 13 5 and cryolipolysis have significant potential for AEs, which is largely
(12W) % 3.1 40.6 40.6 15.6 unregulated and may cause significant pain, hematoma, allergic reac-
Thigh tions, necrosis, scarring, panniculitis, and rapid release of lipids into
Post-­treatment n 0 14 13 5 the bloodstream. In contrast, previous clinical studies supported ther-
(4W) % 0 43.8 40.6 15.6 mal HIFU for body sculpting have had no serious AEs including al-
Post-­treatment n 1 13 11 7 terations in lipid profiles or other laboratory parameters.5–8 Therefore,
(12W) % 3.1 40.6 34.4 21.9 many clinician are keeping an eye on the HIFU technique as purpose
of body sculpting.
0=No change, 1=Mild improvement, 2=Moderate improvement,
3=Significant improvement.
Studies of HIFU facilitate the understanding of mechanisms of
action for body sculpting. When used for body sculpting, HIFU de-
livers focused, high intensity ultrasonic energy to deep subcutaneous
tissue, producing heat capable of effectively ablating adipocytes and
thermally modifying collagen within the tissue matrix. In addition to
local adipocyte necrosis, evidence of collagen remodeling from the
thermal effects of HIFU has been observed.9 Application of HIFU at
a frequency of 1 MHz to adipose tissue leaves collagen fibers intact,
but at frequencies of 2–3 MHz, diffuse contraction of collagen fibers
occurs. Histological analyses performed after the procedure confirm
that HIFU disrupts or denatures collagen fibers, resulting in new colla-
gen formation accompanied by a general tightening of the septal fibers
and skin.9 Based on these results, newly developed transducers for
application to body sites at a variety of focal depths (3.0–9.0 mm) are
deemed to be suitable for body tightening.
Also, we found no thermal damage on the skin surface of the HIFU
F I G U R E 4 Post-­procedural mild erythema on the HIFU treatment site. Kwon et al. has reported the temperature changes of
application site immediately after the treatment (black arrows). the porcine model during HIFU procedure, which showed targeted
Erythema was resolved within 5 days subcutaneous fat to be around 70°C, while the skin surface tempera-
ture only went up to 33.1–35.6°C.10 Therefore, we hypothesized that
newly developed transducers could effectively and safely deliver HIFU
3.2 | Safety
energy deeper into the skin and eventually show body sculpting ef-
The mean pain scores immediately and at 7 days after treatment fects due not only to skin tightening but also to the reduction of sub-
were 3.00±1.586 and 0.031±0.177, respectively. The degree of pain cutaneous fats.
decreased substantially within the first week post treatment. All pa- In this study, we used the Cutometer to evaluate the skin tighten-
tients were able to complete the treatment. No subjects experienced ing effects of HIFU. Objective measurements of skin elasticity after
persistent pain over the treatment areas at 3 months follow-­
up. laser, radiofrequency, and HIFU treatments are desirable. The use of
Erythema was seen in up to 9.38% of the treatment sessions imme- uniform photographic documentation has improved, but there are
diately post-­treatment, but mostly subsided within 5 days (Figure 4). often still inconsistencies in patient position and lighting. Physician-­
No patients showed surface injury or thermal damage on the treat- based grading systems are characterized by inherent elements of
ment site. Ecchymosis was seen in up to 6.25% of treatment sessions subjectivity. The purely objective quantification of results would be
immediately post-­treatment. By 3 days post-­treatment, all cases of of great benefit for the evaluation of skin tightening procedures.
KO et al. | 5

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Not declared.

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