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The Efficacy and Safety of Cryolipolysis for Subcutaneous Fat Reduction

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The Efficacy and Safety of Cryolipolysis for Subcutaneous Fat Reduction

Brief Report
Vol. 30, No. 5, 2018 619
Received June 5, 2017, Revised September 8, 2017, Accepted for publication October 13, 2017
Corresponding author: Sung-Eun Chang, Department of Dermatology, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-ro 43-gil,
Songpa-gu, Seoul 05505, Korea. Tel: 82-2-3010-3467, Fax: 82-2-486-7831, E-mail: csesnumd@gmail.com
ORCID: https://orcid.org/0000-0003-4225-0414
Kyoung Ae Jang, Leaders Clinic, Shinsegae Dept. Store 13 F, 63 Sogong-ro, Jung-gu, Seoul 04530, Korea. Tel: 82-2-310-1945, Fax: 82-2-310-1950, E-mail:
derm722@hanmail.net
ORCID: https://orcid.org/0000-0003-3861-3534
*These two authors contributed equally to this work.
T
his is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/
licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly
cited.
Copyright © The Korean Dermatological Association and The Korean Society for Investigative Dermatology
https://doi.org/10.5021/ad.2018.30.5.619
The Efficacy and Safety of Cryolipolysis for
Subcutaneous Fat Reduction
Heun Joo Lee*, Ho Jeong Shin*, Seung Hee Kang1, Jae-Yeon Park2, Kyoung Ae Jang1,
Sung-Eun Chang
Department of Dermatology, Asan Medical Center, University of Ulsan College of Medicine, 1Leaders Dermatology Clinic, 2Yonsei J Plastic
Surgery, Seoul, Korea
Dear Editor:
Liposuction remains the gold standard method for fat re-
duction; however, it is accompanied by severe adverse ef-
fects, including infection, prolonged recovery time, hema-
toma, and scarring1. Moreover, liposuction has a risk of fa-
tal complications related to anesthesia. Noninvasive tech-
niques of fat reduction have been developed for and pre-
ferred by patients who are seeking safer alternatives to
surgery. Cryolipolysis is one of the most frequently per-
formed noninvasive techniques of fat reduction. Low-level
laser therapy, cryolipolysis, radiofrequency (RF), and
high-intensity focused ultrasound (HIFU) are the four most
common energy devices for fat reduction. Among several
other devices for fat reduction, cryolipolysis and HIFU
were the only devices that have accomplished significant
reductions with a single treatment session2. Cryolipolysis
received Food and Drug Administration clearance for fat
reduction in the flanks in 2010, abdomen in 2012, and
thigh in 2014. However, the procedure has also been
used for off-label treatments of the arms, thighs, knees,
back, and chest3. Although numerous clinical studies have
been conducted in the United States, only a limited num-
ber of patients have been treated and studied in other
countries. In this study, we investigated the tolerance,
safety, and patient satisfaction of cryolipolysis in Korea.
This article reports the results of a retrospective series of
patients treated at multiple private practices in Korea. This
study was approved by the Institutional Review Board of
Asan Medical Center (no. 2016-0669). We received the
patient’s consent form about publishing all photographic
materials. The patients received cryolipolysis treatments
(CoolSculpting; ZELTIQ Aesthetics, Pleasanton, CA, USA)
between May 2014 and December 2015. Trained clini-
cians collected patient data on age, sex, and medical
history. The chart review was conducted at 673 cry-
olipolysis treatment sites in 281 patients. Of the 281 pa-
tients, 41 were available for evaluation. The treatment effi-
cacy was assessed according to circumference measure-
ments before treatment and at the 1-month and 3-month
follow-up. When patients have repeated treatment ses-
sions, we measured the circumference after the last
treatment. As the results can be affected by body weight,
circumference measurements were also performed before
treatment and at the follow-up visits. The abdominal cir-
cumference was measured at the level of umbilicus and
the circumference of treatment sites other than abdomen
was measured at the center of sites pulled into the
applicator. For accuracy, the circumference of all treat-
ment sites was measured at the same point before and af-
ter procedures. The treatment sites included any roll of fat
Brief Report
620 Ann Dermatol
Table 1. Circumference evaluation and satisfaction score according to the treatment sites
Treatment site
Circumference measurements,
Average change from baseline to
1-month follow up (cm)
Circumference measurements,
Average change from baseline
to 3-month follow up (cm)
Average change of
body weight (kg)
Satisfaction
score
Axilla 0.00 0.00 0.00 1.00
Arm 0.09 0.56 0.12 2.06
Upper back 1.00 1.00 3.00 2.00
Lower back 0.00 0.75 0.00 2.00
Upper abdomen 0.29 0.71 0.14 1.29
Lower abdomen 0.33 0.92 0.04 1.88
Upper flank 1.00 1.00 2.00 1.00
Lower flank 0.31 0.69 0.17 1.89
Banana line 0.07 0.37 0.33 2.00
Anterior thigh 0.00 0.50 0.00 3.00
Lateral thigh 0.50 1.13 0.00 2.50
Inner thigh 0.40 0.68 0.00 2.00
Average 0.33 0.69 0.48 1.88
Fig. 1. (A) Baseline and 12 week
post-treatment photos for a 39-year-
old female. Patient received two
sessions of cryolipolysis treatment
to her lower abdomen and both
flank areas. Weight change was
+3 kg from baseline. (B) Baseline
and 12 week post-treatment photos
for a 20-year-old female. Patient
received two sessions of cryoli polysis
treatment to her arms. There was
no weight change.
that could be safely pulled into the applicator. Each treat-
ment session had a duration of 60 minutes. The self-re-
ported patient satisfaction score was assessed 3 months af-
ter the last treatment with measurement of the results, and
was evaluated by using a four-point scale as follows: ‘3’
(75% improvement), ‘2’ (51%75% improvement), ‘1’
(25%50% improvement), ‘0’ (25% improvement).
Safety was evaluated according to the number of adverse
events.
The cryolipolysis procedure was performed at 97 treat-
ment sites in 41 patients. The average patient age was 44
years, and the overall age range was 2169 years.
Treatments were delivered primarily to the lower abdo-
men (26.8%, n=26), lower flank (18.5%, n=18), arm
(17.5%, n=17), inner thigh (10.3%, n=10), banana line
(9.2%, n=9), upper abdomen (7.2%, n=7), lateral thigh
(4.1%, n=4), upper back (2%, n=2), axilla, lower back
(1%, n=1), upper flank (1%, n=1), and anterior thigh
(1%, n=1). A single session of treatment was usually rec-
ommended for each treatment site, and ten patients
(24.3%) received more than two treatment sessions for the
same site. The areas that required more than two sessions
were the lower abdomen, lower flank, arm, lateral thigh,
inner thigh, banana line, and upper back. Four patients re-
ceived more than two sessions on the lower abdomen,
and one of four patients received four cycles of treatment
Brief Report
Vol. 30, No. 5, 2018 621
on the lower abdomen. The average change from baseline
to the 1-month and 3-month follow-up was 0.33 cm and
0.69 cm, respectively (Table 1). The average change of
body weight at 3 months was 0.15 kg. Among the 41
patients, only 3 patients lost weight (1, 2, 3 kg).
Fig. 1 shows the clinical photographs of patients.
Of the 41 patients, 8 (19.5%) reported pain in the treated
area that required analgesics after treatment. None of the
patients reported pain at 2 weeks after treatment. Two pa-
tients (4.8%) reported numbness, and one patient (2.4%)
reported a tingling sensation in the treated site, which sub-
sided spontaneously at 3 days after treatment without fur-
ther intervention. There were no other adverse effects in-
cluding scarring, bleeding, hyperpigmentation, or hypo-
pigmentation. The average satisfaction score was 1.88 of
3. Patients who were treated in the anterolateral thigh re-
ported the highest satisfaction score (2.53).
In general, noninvasive modalities for fat reduction deliver
energy with adipocytes as the target. Heat is the most im-
portant stimulus generated by laser, RF, and ultrasound.
The energy sources of laser, RF, and ultrasound are finally
transformed into the heat, and this thermal energy de-
stroys fat cells4. On the other hand, the mechanism of cry-
olipolysis is completely different from that of other
modalities. Cryolipolysis uses ‘cold’ exposure or thermal
energy reduction to destroy fat cells. The exposure to low
temperature induces apoptosis of adipocytes5. The sus-
ceptibility of adipocytes to cold is greater than that of oth-
er cells, leading to selective adipocyte destruction6. The
surrounding inflammatory cells, especially macrophages,
subsequently engulf and digest the adipocytes6. After 4
weeks of treatment, these inflammatory cell infiltrations
become reduced and the volume of adipose tissue de-
creases7. Two to four months after treatment, the in-
flammatory response further decreases, and the volume of
adipose tissue decreases7. The well-known adverse effects
of cryolipolysis are discomfort (96%), pain (55%), and
bruising (9.5%50%)2. A significant risk of transient sen-
sory nerve dysesthesia, which resolved during 23
months, has been reported, and the histopathologic evalu-
ations showed no significant changes in peripheral nerves5.
In our study, we treated 281 patients, and no patient re-
ported a significant adverse effect including persistent er-
ythema, blistering, or skin necrosis (data not shown).
Although there were reports of numbness (4.8%) and tin-
gling sensation (2.4%) in the treated site, these conditions
subsided spontaneously. The cryolipolysis procedure ach-
ieves selective reduction in superficial fat without causing
injury to the epidermis or dermis. The main advantage of
cryolipolysis is a low profile of adverse effects. Taking the
findings together, although the outcomes of cryolipolysis
are rather modest, this technology is well suited to pa-
tients who desire safe and noninvasive fat reduction.
CONFLICTS OF INTEREST
The authors have nothing to disclose.
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3. Stevens WG, Pietrzak LK, Spring MA. Broad overview of a
clinical and commercial experience with CoolSculpting.
Aesthet Surg J 2013;33:835-846.
4. Mulholland RS, Paul MD, Chalfoun C. Noninvasive body
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The risks, financial costs and lengthy downtime associated with surgical procedures for fat reduction have led to the development of a number of non-invasive techniques. Non-invasive body contouring now represents the fastest growing area of aesthetic medicine. There are currently four leading non-invasive techniques for reducing localized subcutaneous adipose tissue: low-level laser therapy (LLLT), cryolipolysis, radio frequency (RF) and high-intensity focused ultrasound (HIFU). To review and compare leading techniques and clinical outcomes of non-invasive subcutaneous fat reduction. The terms 'non-invasive', 'low-level laser', 'cryolipolysis', 'ultrasound' and 'radio frequency' were combined with 'lipolysis', 'fat reduction' or 'body contour' during separate searches in the PubMed database. We identified 31 studies (27 prospective clinical studies and four retrospective chart reviews) with a total of 2937 patients that had been treated with LLLT (n = 1114), cryolipolysis (n = 706), HIFU (n = 843) or RF (n = 116) or other techniques (n = 158) for fat reduction or body contouring. A majority of these patients experienced significant and satisfying results without any serious adverse effects. The studies investigating these devices have all varied in treatment regimen, body locations, follow-up times or outcome operationalization. Each technique differs in offered advantages and severity of adverse effects. However, multiple non-invasive devices are safe and effective for circumferential reduction in local fat tissue by 2 cm or more across the abdomen, hips and thighs. Results are consistent and reproducible for each device and none are associated with any serious or permanent adverse effects. © 2015 European Academy of Dermatology and Venereology.
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