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FREEZE ON FAT OFF

Treat 2 Areas Simultaneously in Only 40 Minutes.

Upgraded Technology for Enhanced Results.The upgraded 360° surround cooling of the CLATUU Alpha delivers cooling energy throughout the entire applicator and makes it possible to reach the designated treatment temperature at a faster rate, thus increasing efficiency by up to 18%.

The CLATUU Alpha is equipped with an expandable range of applicators that makes it easier than ever to achieve significant results on the most challenging of areas.

360° Surround Cooling Technology

Upper & Lower Abdomen WING Max

Bra Line, Back & Love Handles

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Thighs & Other Flat and Wide Areas

ARC-TUpper & Lower AbdomenFlanks & Other Large Areas

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Abomen & Inner ThighsFLAT

Double Chin, Axilla, Knees & Other Local Regions

FLAT MiniDouble Chin, Axilla, Knees & Other Local Regions

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Fast and Easy Applicator ExchangeWith a simple press-and-release mechanism, the CLATUU Alpha allows maximum convenience and makes switching cooling cups as simple as possible. Detaching cables or turning the system off is not required even during treatments.

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anesthetics on adipocytes. Keck et al. reportedthat several local anesthetics, including lido-caine, markedly impaired adipocyte differentia-tion. They observed that there were significantdifferences in the viability of preadipocytesunder the influence of various local anesthetics(16).Although the exact mechanism of cryolipoly-

sis remains unclear, our investigational resultsconfirmed that non-invasive fat cooling resultsin adipocyte cell death and apoptosis over time.This selective non-invasive treatment for local-ized excess fat was associated with a noticeablereduction in subcutaneous fat in our study anddid not cause skin surface damage. This in vivo

study suggests the newly developed cryolipoly-sis device with a 4D handpiece, when combinedwith tumescent anesthesia, is an effective andsafe treatment for fat reduction. We hope thiswork will encourage additional studies of fatreduction techniques and safer delivery of cry-olipolysis.

Funding sources

None.

Conflicts of interest

None declared.

References

1. Krueger N, Mai SV, LuebberdingS, Sadick NS. Cryolipolysis fornoninvasive body contouring: clini-cal efficacy and patient satisfaction.Clin Cosmet Investig Dermatol2014; 7: 201–205.

2. Nelson AA, Wasserman D, AvramMM. Cryolipolysis for reduction ofexcess adipose tissue. Semin CutanMed Surg 2009; 28: 244–249.

3. Kwon TR, Yoo KH, Oh CT, ShinDH, Choi EJ, Jung SJ, Hong H,Choi YS, Kim BJ. Improved meth-ods for selective cryolipolysisresults in subcutaneous fat layerreduction in a porcine model. SkinRes Technol 2015; 21: 192–200.

4. Mahl JA, Vogel BE, Court M,Kolopp M, Roman D, Nogu�es V.The minipig in dermatotoxicology:methods and challenges. Exp Toxi-col Pathol 2006; 57: 341–345.

5. Yabuki A, Kamimura R, SetoyamaK, Tottori J, Taniguchi K, Mat-sumoto M, Suzuki S. Skin mor-phology of the Clawn miniaturepig. Exp Anim 2007; 56: 369–373.

6. Klein JA. Tumescent technique forregional anesthesia permits lido-caine doses of 35 mg/kg for lipo-suction. J Dermatol Surg Oncol1990; 16: 248–263.

7. Berntorp E, Berntorp K, Brorson H,Frick K. Liposuction in Dercum’s

disease: impact on haemostatic fac-tors associated with cardiovascu-lar disease and insulin sensitivity.J Intern Med 1998; 243: 197–201.

8. Gonz�alez-Ortiz M, Robles-Cer-vantes JA, C�ardenas-Camarena L,Bustos-Salda~na R, Mart�ınez-Abun-dis E. The effects of surgicallyremoving subcutaneous fat on themetabolic profile and insulin sensi-tivity in obese women after large-volume liposuction treat-ment. Horm Metab Res 2002; 34:446–449.

9. Rao RB, Ely SF, Hoffman RS.Deaths related to liposuction. NEngl J Med 1999; 340: 1471–1475.

10. Gulec AT. Treatment of cellulitewith LPG endermologie. Int J Der-matol 2009; 48: 265–270.

11. Moreno-Moraga J, Valero-Alt�es T,Riquelme AM, Isarria-Marcosy MI,de la Torre JR. Body contouring bynon-invasive transdermal focusedultrasound. Lasers Surg Med 2007;39: 315–323.

12. Lach E. Reduction of subcutaneousfat and improvement in celluliteappearance by dual-wavelength,lowlevel laser energy combinedwith vacuum and massage. JCosmet Laser Ther 2008; 10: 202–209.

13. Avram MM, Avram AS, JamesWD. Subcutaneous fat in normal

and diseased state: 1. Introduction.J Am Acad Dermatol 2005; 53:663–670.

14. Tierney EP, Kouba DJ, Hanke CW.Safety of tumescent and laser-assisted liposuction: review of theliterature. J Drugs Dermatol 2011;10: 1363–1369.

15. Keck M, Zeyda M, Gollinger K,Burjak S, Kamolz LP, Frey M, Stul-nig TM. Local anesthetics have amajor impact on viability of prea-dipocytes and their differentiationinto adipocytes. Plast ReconstrSurg 2010; 126: 1500–1505.

16. Keck M, Janke J, Ueberreiter K.Viability of preadipocytes in vitro:the influence of local anestheticsand pH. Dermatol Surg 2009; 35:1251–1257.

Address:Kui Young Park and Beom Joon KimDepartment of DermatologyChung-Ang University Hospital224-1 Heukseok-dongDongjak-kuSeoul 156-755South KoreaTel: +82 2 6299 1525Fax: +82 2 823 1049e-mails: [email protected];[email protected]

9

Efficacy and safety of newly developed cryolipolysis

24.2% after c-c treatment and by 42.3% after n-ctreatment. By 90 days after receiving a tumes-cent solution injection, fat cell size decreased by49.3% in the c-c-treated site and by 66.8% in then-c-treated site. Treatment with the c-c deviceresulted in a 27.6% reduction in fat-cell distribu-tion and treatment with an n-c device led to a49.3% reduction (Fig. 7).

Safety assessment via skin-surface photographyExperts performed a visual safety assessment tocheck for changes or damage to the skin sur-face. We evaluated for skin changes on day 0(immediately after treatment), 1, 7, 30 and 90;our final evaluation was completed on day 90(Fig. 8). Although we noted some erythemaimmediately after applying the cooling devices,the animals recovered within 2–3 days aftertreatment completion. We did not observe anysignificant side effects in the tumescent solu-tion-treated sites.

Discussion

According to the American Society for AestheticPlastic Surgery, by 2013, liposuction hadreplaced breast augmentation as the most popu-lar surgical procedure, with 363,912 proceduresperformed. Its popularity has grown consider-ably because it offers esthetic improvement andnumerous metabolic benefits (7, 8). Despite itspopularity, liposuction is associated with rarebut significant risks that can sometimes be fatal,including complications from anesthesia andinfections (9). Currently available nonsurgicalliposuction procedures employ mechanical vac-uum massage, lasers, radiofrequency, ultra-sound, or low-level energy infrared light, but

these techniques are not intended for theremoval of large volumes of fat (10).Current cryolipolysis procedures are per-

formed with either small or large vacuum-pres-sure applicators that are capable of extractingheat from both sides of a fold and reducingblood flow via tissue compression and cold-induced vasoconstriction (11–13). Two mecha-nisms of fat-cell loss have been described in theliterature (dedifferentiation and apoptosis), andthe results we present here are consistent withthe conclusion that exposure to cold inducesfat-cell apoptosis (14).Conventional cryolipolysis equipment con-

tains a cooling-plate-mounted applicator, butthe newly developed cool4D� has an applicatorthat acts as its own cooling plate. It has theworld’s first 360° cooling panel that can delivercooling energy more effectively than the con-ventional two-sided model (Fig. 9).The advantages of this new device are its

higher cooling conductivity and that it deliversuniform cooling energy to the skin better thanthe conventional applicator. Its cooling effectsare not focused on limited areas and it caneffectively reduce subcutaneous fat. A rareside effect of cryolipolysis is frostbite.Improved technology allows it to maintain astable cooling temperature so that it can pro-vide enhanced treatment results in a shortertime period compared with conventional meth-ods. Furthermore, we found a strongerdecreasing effect for subcutaneous fat by90 days after treatment with the n-c comparedwith the c-c.Klein’s introduction of the tumescent lipo-

suction technique in 1987 revolutionized thefield of cosmetic body-fat sculpting. Somedebates about the use of tumescent solution

0

500

1000

1500

2000

2500

3000

3500

4000

0 day 90 day

Area 1Area 2Area 3Area 4

Fat c

ell s

ize

(µm

2 )

0

20

40

60

80

100

120

0 day 90 day

Area 1Area 2Area 3Area 4

Fat c

ell a

rea

(%)

Fig. 7. Changes in fat-cell size and number after treatment with the two cooling devices with/without tumescent solution at day 0 vs. day 90.

7

Efficacy and safety of newly developed cryolipolysis

Non-invasive tumescent cryolipolysis using a new 4D

handpiece: a comparative study with a porcine model

S. Y. Jeong1,2, T. R. Kwon1, J. Seok1, K. Y. Park1 and B. J. Kim1

1Department of Dermatology, Chung-Ang University College of Medicine, Seoul, Korea and 2GoodDay Skin & Laser Clinic, Seoul, South Korea

Background/Purpose: The growing demand for a youthful

appearance, including a favorable body shape, has motivated

recent developments in noninvasive body contouring tech-

niques. Our aim was to investigate the efficacy and safety of a

new version of a 4D handpiece-mounted cooling device for

cryolipolysis with or without tumescent injections.

Methods: We conducted a side-by-side comparative study

using two female porcine models. Two areas of each pig’s

left abdomen were treated using a conventional device and

the new cooling device, and two areas of the right abdomen

were also treated using the conventional and new cooling

device, but both were combined with tumescent-solution

injections.

Results: The conventional method alone yielded a 75.25%

reduction in skin thickness, while the new cooling device alone

yielded a 81.63% reduction. When paired with tumescent injec-

tions, the conventional device yielded a 86.3% reduction in

skin thickness and the cooling device yielded a 85.9% reduc-

tion. Using histological analysis with H&E, oil red O, and tolu-

idine blue stain, we confirmed that selective cryolipolysis was

able to induce selective apoptosis of fat cells.

Conclusion: This in vivo study presents a new 4D handpiece-

assisted cooling device with tumescent anesthesia that is safe

and effective for fat reduction.

Key words: cryolipolysis – fat – 4D handpiece – tumescent

� 2016 John Wiley & Sons A/S. Published by JohnWiley & Sons LtdAccepted for publication 21 June 2016

VARIATION IN fat accumulation patterns leadsto differential contour changes along the

human body. These contour changes are relatedto a complex combination of factors, includinglifestyle, age, gender, hormone levels, andgenetic elements. Fat accumulation in thehuman body has dramatically increased in thepast few decades and is associated with manydiseases and various other health problems.Consequently, research efforts to develop amore effective and safe method for fat reduc-tion are steadily increasing.In recent years, there has been a strong focus

on developing non-invasive methods as analternative to liposuction; particularly promis-ing emerging techniques include cryolipolysis,high-intensity focused thermal ultrasound,radiofrequency ablation, and low-level externallaser therapy. Each technology employs a differ-ent mechanism to cause apoptosis or necrosis oftargeted adipocytes. Cryolipolysis, a medicaltreatment used to destroy fat cells, relies oncontrolled cooling for non-invasive localizedreduction of fat deposits, resulting in reshaped

body contours. Cooling exposure is calibratedto cause cell death in subcutaneous fat tissuewithout damaging the overlying skin. In 2010,the US Food and Drug Administrationapproved the first cryolipolysis device and pro-cedure (1). Initial animal and human studieshave yielded significant reductions in superfi-cial fat layer thickness, ranging from 20% to80%, following a single cryolipolysis treatment.Decreases in fat thickness occur gradually overthe first 3 months following treatment, and aremost pronounced in patients with limited, dis-crete fat bulges (2). However, cryolipolysis isassociated with local side effects, includingtransient redness, bruising, skin numbness, anduneven fat reduction. Therefore, improvementsto cryolipolysis equipment for more effectiveand safe fat removal are necessary.We performed this study to compare the effi-

cacy and safety of a newly developed improveddevice (cool4D�; Classys Inc., Seoul, Korea),hereafter referred to as n-c, with a commerciallyavailable cooling device (CLATUU�; ClassysInc.), hereafter referred to as c-c (3).

1

Skin Research and Technology 2016; 0: 1–9Printed in Singapore � All rights reserveddoi: 10.1111/srt.12305

© 2016 John Wiley & Sons A/S.Published by John Wiley & Sons Ltd

Skin Research and Technology

Our clinical results confirmed that non-invasive fat cooling results in adipocyte cell

death and apoptosis over time.

It has the world’s first 360° cooling panel that can deliver cooling energy more effectively

than the conventional two-sided model.

Stronger Suction

Adjustable LevelsNot only is the CLATUU Alpha capable of 20% stronger suction, it also provides medical practitioners with the ability to adjust both cooling and suction levels to confidently provide customized treatments for patients.

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Customized Solutions for the Most Challenging of Patients’ Needs.




Proven Results

Post 13 Weeks / 1 SessionBaselineWING Max for Large Fat Pockets

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Baseline Post 6 Weeks / 1 Session


Post 8 Weeks / 1 SessionBaselineFLAT for Small Fat Pockets

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