Ideas and Innovations

Cosmetic
Three-dimensional Cryolipolysis for Submental and
Lateral Neck Fat Reduction
Stavroula Rodopoulou, MD,
FEBOPRAS Summary: Median and lateral neck areas are quite challenging to improve. Three-
Maria-Ioanna Gavala, MD dimensional cryolipolysis is a noninvasive technique for localized fat reduction. We
Evangelos Keramidas, MD, investigated the efficacy and safety of the technique when applied to these areas. A
FEBOPRAS prospective study of patients treated with one session of 3-dimensional (3D) cryo-
lipolysis is performed. Clinical outcomes are assessed using caliper measurements,
patient surveys, and independent, blinded plastic surgeons’ photographic evalua-
tion. The studies are conducted using a commercially available noninvasive medical
device for 3D cryolipolysis. All patients received gentle massage of the treated areas
for 3 minutes, and the final follow-up is after 3 months. Thirty-nine patients are
enrolled in our study from June 2018 to December 2018. All 39 subjects received
treatment on at least one intended area (median, right, and left lateral neck).
Comparison of the pre- and posttreatment caliper measurements demonstrated
a significant reduction of the treated areas at 3 months. Posttreatment, 82.05%
of patients marked the results of fat reduction as exceptional or very improved,
12.82% as improved, 5.13% as no result, and 0% as worse. Improved patients and
the blinded plastic surgeons noticed at these patients’ groups a bonus tightening
effect. No serious adverse reactions are observed; thus, 3D cryolipolysis consid-
ered as a safe and effective noninvasive localized fat reduction technique with an
extra, almost regularly observed, tightening effect. (Plast Reconstr Surg Glob Open
2020;8:e2789; doi: 10.1097/GOX.0000000000002789; Published online 29 April 2020.)

INTRODUCTION skinfold caliper of at least 1 cm, minor to moderate skin lax-

Submental fullness is a rising aesthetic issue that has a ity, body mass index that ranged between 18.5 and 34.9 and
profound impact on one’s facial features. In the era of min- agreed to maintain their body weight within 5% of the base-
imally invasive medical aesthetic procedures,1 cryolipolysis line during the study, and they were in general good health.
has received much attention due to its proven safety, good All subjects provided written informed consent.
patient tolerance, and efficacy.2–5 We present the results of
39 patients who underwent a 3-dimensional (3D) cryolipol- End Points
ysis solitary treatment cycle for the submental and lateral The safety end point of the device and/or procedure-
neck areas, using a novel, small, vacuum cryolipolysis cup related adverse effects were examined. Immediately after
applicator. To the best of our knowledge, this is the first treatment, at 1 week and at 12 weeks post treatment, a clinical
office-based study concerning the entire neck area. examination was performed and the patients filled in written
questionnaires evaluating the pain and common symptoms.
Efficacy of treatment end points, between baseline
MATERIALS AND METHODS and 12 weeks post treatment, were: statistically significant
Thirty-nine patients were enrolled in this study generated
reduction of the skinfold caliper measurements, at least
in our private practice between June 2018 and December
80% correct identification of pre- and post treatment
2018. Eligible participants demonstrated visible accumu-
images assessed by a blinded panel of 3 independent
lation of submental and/or lateral neck fat, measured by
board-certified plastic surgeons and at least 90% subject
From the Kosmesis Aesthetic Plastic Surgery Center, Athens, Greece.
satisfaction rate using patient surveys.
Received for publication January 9, 2020; accepted February 26,
Documentation
2020.
Before treatment and at 12-week follow-up visits,
Presented at the IMCAS Paris, January 31-February 2 2019, France photographies were obtained with the subject’s head
Copyright © 2020 The Authors. Published by Wolters Kluwer Health, in a neutral, sitting, and stable position. Caliper mea-
Inc. on behalf of The American Society of Plastic Surgeons. This surements were undertaken by the same physician, and
is an open-access article distributed under the terms of the Creative an average of 3 different measurements was calculated.
Commons Attribution-Non Commercial-No Derivatives License 4.0 A transparent malleable film was also used to draw the
(CCBY-NC-ND), where it is permissible to download and share the
work provided it is properly cited. The work cannot be changed in Disclosure: The authors have no financial interest to declare
any way or used commercially without permission from the journal. in relation to the content of this article.
DOI: 10.1097/GOX.0000000000002789

www.PRSGlobalOpen.com 1
 PRS Global Open • 2020

exact landmark points of the measurement and individ- Patients’ surveys according to the GAIS 5-point scale
uals’ jawline to easily reuse it in a conventional manner (Global Aesthetic Improvement Scale), showed that
in the follow-up visit. 82.05% considered the results of fat reduction as excep-
tional or very improved, 12.82% as improved, 5.13% as
3D Cryolipolysis Treatment no result, and 0% as worse. An additional outcome is that
A commercially available device (CLATUU Alpha 69.24% of patients marked the results of skin’s tighten-
from Classys Inc, Seoul, South Korea, CE marked as ing as exceptional or very improved, 20.51% as improved,
medical device, Korean FDA, Thai FDA) was used in this 10.26% as no result, and 0% as worse. A very high per-
study including a dual handpiece: a wing and a flat mini centage of patients (94.9%) would recommend 3D cryo-
applicator that can function simultaneously. The adjust- lipolysis to a friend and 92.3% found the procedure to
able parameters were suction, cooling, and duration. All be comfortable, generating for the whole study outcome a
39 subjects received treatment on at least one intended high subject satisfaction rate (93.6%). Thus, all safety and
area. For the purpose of this study, submandibular and efficacy endpoints were satisfied.
carotid triangles were referred as lateral neck areas. Each
treatment session included a minimum of 1 and a maxi-
DISCUSSION
mum of two 60 minutes cooling cycles, if applied in sub-
Primary results of this study demonstrate neck’s fat
mental and both lateral neck areas. Treatment areas were
reduction and contouring improvement after a single
marked and a disposable gel pad (CLATUU Matrix gel
hourly session of 3D cryolipolysis while providing safety,
pad from Classys Inc, Seoul, South Korea, Korean FDA,
tolerability, and high patient satisfaction.
Thai FDA) was used to fully cover and protect them,
Previous studies investigated cryolipolysis in submental
followed by application of the suction cup. Maximum
area using a device with an originally introduced 2-sided
suction pressure (30 Kpa) and maximum cooling tem-
cooling plate technology of the vacuum cup applicators.5–8
perature (−7°C) were then applied for 1 hour. A neck
In our study, another cryolipolysis device was used intro-
pillow and straps were used to stabilize the handpieces.
ducing a new patented 3D technology to treat the entire
At the end of the treatment, the area was manually mas-
neck area. In 3D cryolipolysis that was investigated in this
saged for 3 minutes, allowing the stiff tissue to gradually
study, a 360° surrounding cooling effect (−7°C) was main-
rewarm and regain its original shape.
tained three-dimensionally to the whole suctioned tissue
(30 Kpa), for 1 hour. This may hypothetically lead to a
RESULTS more even “cooling shock” of the treated area, and there-
Safety assessment revealed that 46.15% of patients men- fore, a greater number of adipocytes cells were forced
tioned minor pain during the procedure. Immediately to apoptosis and permanent death, even after a solitary
after treatment, minor edema, redness, numbness, and application.
tingling of the area were observed which, in most cases, A limitation of this study is the absence of a standard-
resolved within hours or a few days. Other side effects ized method to quantify objectively fat reduction, except
included discomfort during therapy due to vacuum’s cap of the skinfold caliper measurements. Regarding skin
weight that resolved in a few minutes. By the 12-week final tightening after 3D cryolipolysis treatment, it is a clinical
evaluation visit, all side effects were self-resolved. Side finding, both from patients and plastic surgeons involved
effect profile considered to be safe and tolerable. in the study judgment, but has not yet been confirmed
Skinfold caliper measurements were analyzed to calcu- through histologic examination. Skin firmness could be
late fat reduction (Table 1). attributed probably to neocollagenesis stimulation and
Submental areas showed a mean (SD) fat layer reduc- has been reported in previous case study reports.7,9,10
tion of 7.4 mm (2.4) or 35.3%. Concerning the right lat- According to Carruthers et al9 as dermal fillers may stimu-
eral neck areas, mean (SD) reduction was 5.5 mm (1.1) late neocollagenesis by stretching of the fibroblasts, simi-
or 30.51%, and for the left lateral neck areas, mean (SD) larly the mechanical stretching of the fibroblasts due to
reduction reached 5.2 mm (1.2) or 32.1%. MATLAB (from vacuum suction of the fatty bulge may be a contributing
The Mathworks, Inc., Natick, Mass.) was used for all statisti- factor to neocollagenesis in cryolipolysis. Another factor
cal analysis. Figures 1, 2 show a representative participant. might be the gradual fat elimination that might allow the
From the independent photographic review, the skin to adjust more effectively in time and cover without
overall correct identification rate was 94.9% (111/117). excess, the resulted thinner fat pocket.

Table 1. Results with Pairwise Comparisons between Baseline and 12-week Follow-up
Between Baseline and
% of Submental 12-wk Follow-up Difference
Baseline 12-wk Follow-up Fat Reduction in Means (SD) P
Thickness of median (submental) and lateral neck fat (mm), mean (SD)
Right (n = 11) 18.2727 (3.1652) 12.7273 (2.5334) 0.3051 (0.0455) 16.3029 (1.1282) <0.01 (1.5664e-08)
Median (n = 38) 20.9211 (5.3594) 13.5000 (3.6373) 0.3530 (0.0633) 18.7921 (2.4343) <0.01 (1.6198e-20)
Left (n = 9) 16.5556 (4.2164) 11.3333 (3.4641) 0.3212 (0.0630) 11.2351 (1.3944) <0.01 (3.5356e-06)
Average 19.7414 (5.0837) 13.0172 (3.4666) 0.3390 (0.0627) 22.2629 (2.3002) <0.01 (8.4677e-30)

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Rodopoulou et al. • 3D Cryolipolysis for Neck Fat Reduction

Fig. 1. Patient's baseline measurements: (A) submental 19 mm; (B) right lateral neck 19 mm; and (C) left
lateral neck 17 mm (not shown).

Fig. 2. Patient's measurements 3 months post treatment (A) submental 11 mm; (B) right lateral neck
12 mm; and (C) left lateral neck 12 mm (not shown).

Considering the treatment and consumables cost, 2. Dierickx CC, Mazer JM, Sand M, et al. Safety, tolerance, and
it is quite affordable, which is an important factor in patient satisfaction with noninvasive cryolipolysis. Dermatol Surg.
private practice both for patient’s decision-making to 2013;39:1209–1216.
3. Ingargiola MJ, Motakef S, Chung MT, et al. Cryolipolysis
undergo treatment and from the physician’s point of view.
for fat reduction and body contouring: safety and effi-
Moreover, it should be noted that for this study popula- cacy of current treatment paradigms. Plast Reconstr Surg.
tion, the 3D cryolipolysis treatment was not free of charge, 2015;135:1581–1590.
and, thus, the overall 94.9% satisfaction rate highlights 4. Derrick CD, Shridharani SM, Broyles JM. The safety and efficacy
the objectivity of their judgment. of cryolipolysis: a systematic review of available literature. Aesthet
Surg J. 2015;35:830–836.
5. Kilmer SL, Burns AJ, Zelickson BD. Safety and efficacy of cryo-
CONCLUSION lipolysis for non-invasive reduction of submental fat. Lasers Surg
The results of this study demonstrate that this novel 3D Med. 2016;48:3–13.
cryolipolysis treatment can lead not only to safe, well toler- 6. Lipner SR. Cryolipolysis for the treatment of submental fat:
ated, and effective fat reduction, but also skin tightening review of the literature. J Cosmet Dermatol. 2018;17:145–151.
in the entire neck area, following a single, 1-hour session. 7. Bernstein EF, Bloom JD. Safety and efficacy of bilateral sub-
mental cryolipolysis with quantified 3-dimensional imaging
Stavroula Rodopoulou, MD, FEBOPRAS of fat reduction and skin tightening. JAMA Facial Plast Surg.
Kosmesis Aesthetic Plastic Surgery Center 2017;19:350–357.
Ethnikis Antistaseos 9-11 8. Leal Silva H, Carmona Hernandez E, Grijalva Vazquez M, et al.
Chalandri, Athens 15232, Greece Noninvasive submental fat reduction using colder cryolipolysis. J
E-mail: villyro@yahoo.com Cosmet Dermatol. 2017;16:460–465.
9. Carruthers J, Stevens WG, Carruthers A, et al. Cryolipolysis and
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