SADICK VenusLegacy CoolsculptStudy

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November 2016 1354 Volume 15 Issue 11
Copyright 2016 ORIGINAL ARTICLES Journal of Drugs in Dermatology
SPECIAL TOPIC
Prospective Internally Controlled Blind Reviewed Clinical

Evaluation of Cryolipolysis Combined With Multipolar
Radiofrequency and Varipulse Technology for Enhanced
Subject Results in Circumferential Fat Reduction
and Skin Laxity of the Flanks
Julius Few MD,a Michael Gold MD FAAD,b and Neil Sadick MD FACP FAACS FACPh FAADc
The Few Institute, Chicago, IL
a
Gold Skin Care Center; Tennessee Clinical Research Center, Nashville, TN

b
c
Department of Dermatology, Weill Cornell Medical College; Sadick Dermatology, New York, NY
ABSTRACT
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Background: Increasing demand for non-invasive skin tightening and body contouring procedures has led to several technological in-
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novations in energy-based devices such as ultrasound, radiofrequency and cryolipolysis. An emerging trend in the field is to evaluate
whether combination therapies for skin laxity/body contouring using energy-based devices can deliver superior clinical results and
patient satisfaction. As such, the objective of this prospective, internal-controlled, blind clinical study was to assess the safety and ef-
ficacy of cryolipolysis followed by multipolar radiofrequency with pulsed electromagnetic fields (PEMF) and adjustable pulsed suction
for the treatment of skin laxity in the flanks.
Methods: Ten subjects with focal adiposities in the flanks were enrolled in the study. All subjects received one session of cryolipolysis
treatment and after randomization received two sessions of radiofrequency with PEMF (spaced two weeks apart), followed by another
two sessions of radiofrequency with PEMF and adjustable pulsed suction (spaced two weeks apart). Clinical photography was used to
monitor the subjects results at baseline, one week, three, and six months post treatment. Blinded reviewers and the treating inves-
tigator assessed the clinical outcomes using the Global Aesthetic Improvement (GAI) scale. Side effects were recorded at every visit
and patient satisfaction was noted at the one week, three and six-month follow-up using a 5-scale subject satisfaction assessment
questionnaire.
Results: Analysis of the blinded investigator ratings demonstrated statistical significant enhanced skin laxity mean improvement of
1 grade on the GAI scale in subject treated with the combination treatment (cryolipolysis+RF/PEMF/suction) compared with the
cryolipolysis treatment alone. The unblinded investigator GAI ratings also showed enhanced (20%) mean improvement of laxity in the
combination treated subjects versus those receiving cryolipolysis alone. Over half of the participants reported satisfaction with both
treatment results, but there was a 10% statistically significant higher satisfaction rating of the outcomes in the flank treated with the
combination treatment. Procedures were well tolerated, side effects were transient and self-resolving and no unexpected adverse ef-
fects were reported for the duration of the study.
Conclusion: The results of this study show that the combination of multipolar RF with PEMF/suction following cryolipolysis is a safe,
effective, and painless approach to enhance skin tightening following fat reduction procedures in the flanks.
J Drugs Dermatol. 2016;15(11):1354-1358.
INTRODUCTION
T
he demand for non-invasive skin tightening, body con- to stimulate intrinsic metabolic pathways that lead to lipolysis
touring and localized excess fat deposit reduction pro- and neocollagenesis.
cedures has grown dramatically over the past decade
as new treatments and technologies have been introduced. Radiofrequency mediates thermal stimulation of the ex-
During this period, there has been a substantial increase in en- tracellular matrix in the dermis and aims to deliver heat at
ergy-based technologies available for skin laxity, cellulite and a controlled depth. This results in an immediate and tempo-
fat reduction including radiofrequency, ultrasound, acoustic rary shrinkage of the collagen triple helix1-8 and subsequent
waves, low-level laser therapy, and cryolipolysis. By harnessing stimulation of the fibroblast which in response produces new
energy from various sources, the scope of these technologies is collagen (neocollagenesis), new elastin (neoelastogenesis)
2016-Journal of Drugs in Dermatology. All Rights Reserved.
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1355
Journal of Drugs in Dermatology J. Few, M. Gold, N. Sadick
November 2016 Volume 15 Issue 11
and ground substances together with growth factor infiltration multipolar/PEMF/suction treatments spaced one week apart
that rejuvenates the tissue according to the wound healing using the 4D body applicator. At the conclusion of the study,
cascade. This results in enhanced tensile strength and elastic- subjects had the option to undergo optional RF equalization
ity of the dermis with the aid of the newly produced proteins treatments with the Venus Legacy device on the control side.
and protoglycans.1-8 One of the latest generation of radio-
frequency devices for skin tightening, body contouring and The cryolipolysis treatment was done using the CoolSculpting
localized excess fat deposit reduction combines multi-polar system (Zeltiq, Pleasanton, CA) according to the manufactur-
RF with pulsed electromagnetic fields (PEMF) and adjustable ers instructions. The treatment area was cleaned with isopropyl
pulsed suction for deep energy penetration, lymphatic drain- alcohol and after securing the applicator on the treatment area,
age, and stimulating circulation. The device, Venus Legacy treatment was initiated (41.6C, 60 minutes). The subjects level
(Venus Concept, Ontario, CA) exploits the synergist effects of comfort was assessed during treatment and at the conclu-
of PEMF, which via a non-thermal stimulates neovascularity, sion of the treatment, the treatment site was examined for
fibroblast proliferation, and collagen neosynthesis with the any epidermal, dermal or subcutaneous findings (eg, blanch-
thermal RF-mediated denaturation/contraction of existing col- ing, erythema, bruising, swelling); alterations in sensation (eg,
lagen. PEMF has been used in medicine for decades and is numbness, tingling) and pain score was be assessed. Post-
scientifically proven with regard to its regenerative properties
through the upregulation of several cytokines including bone Do Not Copy
treatment massage was performed.
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morphogenetic proteins 2 and 4 (BMP2, BMP4), transform- Multipolar radiofrequency with PEMF treatments were deliv-
ing growth factor-beta (TGFb), and fibroblast growth factor-2 ered using the Venus Legacy system (VenusConcept, Toronto,
(FGF-2).9-13 Application of this RF-device for skin rejuvenation CA). The applicator was placed in close contact with the skin,
and laxity has been extensively evaluated and proven to de- and moved on the treatment area. As soon as the body
liver superior clinical results.7 reached therapeutic temperatures (42C - 45C) the treatment
continued according to subject feedback. During whole treat-
Cryolipolysis treatments on the other hand deliver precisely ment duration, subject reaction was monitored and pain score
controlled cooling to gently and effectively target the fat cells was noted.
underneath the skin. Treated fat cells are crystalized frozen and
over several weeks post-treatment undergo apoptosis and are Clinical Evaluations
naturally eliminated via phagocytosis.14 One of the main cryoli- Each subject had screening assessment and photographs were
polysis devices is the CoolSculpting system (Zeltiq, Pleasanton, taken using high-resolution clinical photography; pre-treatment
CA) that features applicators for various anatomic areas includ- (baseline), one-week post treatment, at 3- and 6-months post
ing the abdomen, flanks, arms, and chin. The CoolSculpting treatment. Evaluations of flanks were conducted using the Glob-
System is designed to cool subcutaneous fat without affecting al Aesthetic Improvement (GAI) Scale by the investigator and
adjacent or underlying structures by delivering low tempera- two blinded experienced plastic surgeon reviewers (Table 1) at
tures at a controlled preset level and providing continuous
feedback on the temperature at the skin interface. TABLE 1.
Global Aesthetic Improvement (GAI) Scale
The objective of this prospective, internally controlled blind
study was to evaluate whether combination of cryolipolysis us- Score Improvement
ing the Coolscupting system followed by radiofrequency using Very Much Optimal cosmetic result in this
-3
the Venus Legacy device would lead to enhanced clinical out- Improved subject
comes in skin laxity of the flank area. Marked improvement in appearance
-2 Much Improved from the initial condition, but not
MATERIALS AND METHODS completely optimal for this subject
Treatments -1 Improved
Obvious improvement in appearance
Ten healthy subjects (9 females, 1 male) between the ages from the initial condition.
of 21 and 50 years with excess focal adiposities in the flanks The appearance is essentially the
0 No Change
were enrolled in the study. Subjects were randomized after same as baseline.
meeting all the inclusion/exclusion criteria and providing The appearance is worse than the
(-1) Worse
signed informed consent. All subjects underwent one ses- original condition
sion of cryolipolysis on both flanks. The randomized flank Marked worsening in appearance
(-2) Much Worse
received the following treatments two weeks after cryolipol- from the initial condition.
ysis: 1) Two multipolar/PEMF treatments spaced one week Obvious worsening in appearance
(-3) Very Much Worse
apart with the Venus Legacy Octipolar applicator and 2) Two from the initial condition.
1356
FIGURE 1. Mean average of GAI scale assessments of subjects by two FIGURE 2. Mean average of GAI scale assessments of subjects by
blinded investigators at the 6 month follow up. unblinded investigators at the 6 month follow up.
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the 1 one-week, 3- and 6-month follow up. Subjects reactions Assessment questionnaire. Analysis of the results demonstrat-
to treatments were examined by the principal investigator or ed a significant increased mean satisfaction in the flank that
delegated trained personnel at the end of each treatment while received the combination treatment compared with the cryoli-
subjects satisfaction was assessed with the help of a 5-scale polysis treated side (Figure 5).
Satisfaction Assessment questionnaire (4 = Very Satisfied, 3 =
Satisfied, 2 = Having No Opinion, 1 = Unsatisfied, 0 = Very Unsat- At the end of every treatment, sites treated with a combination
isfied) at the one-week, 3- and 6-month follow-up. of cryolipolysis and multipolar RF/PEMF/suction were exam-
ined for the following adverse skin reactions and pain score
Statistical Analysis was also assessed. There was no severe adverse reaction on
Study data were analysed using a combination of descriptive sites treated with both cryolipolysis and multipolar RF/PEMF/
statistical tools and Wilcoxon Matched-Pairs Signed-Ranks Test. suction. No subject treated with a combination of cryolipolysis
and multipolar RF/PEMF/suction experienced purpura while
RESULTS no subject treated with cryolipolysis device experience bruis-
All 10 subjects completed the study and the following results ing. An average of 70% of sites treated with a combination of
were obtained from analysing the blinded investigator as- cryolipolysis and multipolar RF/PEMF/suction experienced
sessments of photographs of subjects flanks at the 6-month modest heat sensation, while 35% and 7.5% of sites treated had
follow-up. Statistical analysis of the Global Aesthetic Improve- modest erythema and edema, respectively. All reported cases
ment (GAI) Scale assessments demonstrated a significant were temporary and improved over time.
improvement in skin laxity reduction by a mean average grade
of 1 in subjects flanks treated with a combination of cryolipoly- DISCUSSION
sis, two treatments of multipolar RF/PEMF and two treatments From the study data results, it is evident that treating cir-
of multipolar RF/PEMF/suction compared to the flank that re- cumferential fat reduction and skin laxity of the flanks with
ceived cryolipolysis only (P<0.1; Figure 1). cryolipolysis procedure is safe and effective but patients will
benefit enhanced results when treated with a combination
In addition to assessment of subjects flanks photographs by of cryolipolysis, followed treatments with multipolar RF/
blinded expert reviewers, 6-month post-treatment GAI Scale PEMF/suction. Although improvement did not reach statistical
scores of subjects flanks by unblinded Principal Investigator significance (0.05<P<0.1) during the analysis of GAI scale as-
were analysed and demonstrated a significant improvement sessments of both the blinded and unblinded investigators, this
in skin laxity of 20% in subject flanks that received the com- was likely due to the pilot nature of the study and small number
bination treatment compared to those receiving cryolipolysis of enrolled subjects. Post-hoc analysis of the data revealed that
treatment only (Figure 2, 3, 4). a minimum of 70 participants would be required in order for
values to have reached statistical significance. Nevertheless,
Subjects satisfaction with the treatment outcomes of flanks re- subjects satisfaction assessment of the clinical outcome of
ceiving cryolipolysis and those treated with a combination of the flanks treated with the combination protocol together
cryolipolysis and multipolar RF/PEMF/suction were recorded with the safety profile of the overall treatment strategy sup-
at the 6-month post treatment visit using a 5-scale Satisfaction ports proposing this method during patient consultations
1357
FIGURE 3. Male patient at baseline (A) and at the six month FIGURE 4. Female patient at baseline (A) and at the six month
follow-up (B) Both flank were treated with cryolipolysis but the left follow-up (B). Both flank were treated with cryolipolysis but the right
flank received additional treatments with multipolar RF/PEMF/suction. flank received additional treatments with multipolar RF/PEMF/suction.
(A) (A)
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(B) (B)
for non-invasive body rejuvenation. Thus despite the small

sample size and the fact that larger scale studies will be con-
FIGURE 5. Mean average of subject satisfaction assessments scale at
ducted, the positive results of this study indicate the protocol the 6 month follow up.
design was simple and effective, without requiring subject
downtime or lengthy investment in treatment time. Clini-
cal outcomes and patient feedback merit evaluating similar
protocols in other anatomical areas that would benefit from
simultaneous fat reduction and improvement of skin laxity,
such as the arms, abdomen and lower body.
CONCLUSION
The results and data analysis generated from this study con-
firm that circumferential fat reduction and skin laxity of the
flanks treatment with a combination of cryolipolysis with mul-
tipolar RF/PEMF/suction yield enhanced results for patients
compared to when either of the technology is used alone.
1358
DISCLOSURES
Dr. Neil Sadick is a consultant/board member for Venus Con-
cept. Dr. Michael Gold has stock options and is a consultant for
Venus Concept. Dr. Julius Few is an investigator and consultant
for Zeltique and Venus Concept
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AUTHOR CORRESPONDENCE
Neil Sadick MD FACP FAACS FACPh FAAD

E-mail:.................................. nssderm@sadickdermatology.com


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To order reprints or e-prints of JDD articles please contact sales@jddonline.

Prospective Internally Controlled Blind Reviewed Clinical

Gold Skin Care Center; Tennessee Clinical Research Center, Nashville, TN

J Drugs Dermatol. 2016;15(11):1354-1358.

for non-invasive body rejuvenation. Thus despite the small

Neil Sadick MD FACP FAACS FACPh FAAD

2016-Journal of Drugs in Dermatology. All Rights Reserved.

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