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LIPOKONTUR - ABSTRACT MERGED STUDY
1. COMBINED TECHNIQUES TO PERFECT THE BODY – LIPOKONTUR™:
COMBINING SHOCKWAVE/RADIO-FREQUENCY USING THE SHYLD™
PROTOCOL
(Abstract)
Co-Authors: Dr. Ashraf Badawi, MD, PhD, Dr. Dan J. Castro, MD, Dr. Peter M. Prendergast, MD,
Dr. Marie-Jeanne Miniconi, Dr. Micheline Clavé
INTRODUCTION & OBJECTIVES:
This report is a preliminary description of a 4-month informal study which evaluated the safety and
efficacy of an innovative, versatile, cost effective and non-invasive therapy concept we call the SHYLD™
Concept, using the LIPOKONTUR™ device for the treatment of cellulite, stretch marks, body contouring
and face and neck skin tightening.
In the last few years combining techniques, modalities and technologies prevail. Using complementary
methods and devices has proven to achieve better outcomes in challenging aesthetic procedures like
cellulite improvement or body contouring. New devices, combining energies used sequentially (based on
advanced medical protocols like SHYLD™), have shown excellent results so far. They are also easy to use
and safe, sophisticated all-in-one machines, hence avoiding the need to purchase multiple devices.
LIPOKONTUR™ offers in one machine both Radial Shockwaves Energy (RSWT) and a 4th generation
Multi-Polar RF technology for body sculpting, cellulite and treatment of stretch
marks as well as face and neck skin tightening. It is a compact device yet very
powerful, for use in private offices. It uses only few consumables, and can be
easily moved from one clinical site to another, enabling the practitioner to treat
a wider client base, with lower starting costs and greater efficiency.
In this informal clinical study we have tested the effectiveness of the SHYLD™
Concept protocol, using the LIPOKONTUR™ device for the treatment of upper
thighs, buttocks and abdominal cellulite, love-handles, circumferential reduction
and stretch marks.
KEY WORDS: non-invasive technique. Fatty tissue and fibrous cellulite. Localized adiposity. High demand
procedure. Social problem. Ideal alternative to liposuction
2. COMBINED TECHNIQUES TO PERFECT THE BODY – LIPOKONTUR™:
COMBINING SHOCKWAVE/RADIO-FREQUENCY USING THE SHYLD™
PROTOCOL
(Abstract)
MATERIALS AND METHODS:
THE PURPOSE: to apply the SHYLD™ protocol, using the LIPOKONTUR device to apply the SHYLD
protocol (Shock, Hyperthermia, Lymphatic Drainage), for treating the superficial layer of the fat with
radiofrequency combined with acoustic waves and to eliminate it with lymphatic drainage.
METHODS: four sessions required, once a month, one session on the same area; several areas can be
treated concurrently during the same session. Each session lasts about 50 minutes per zone; 3 steps (
step1: acoustic wave therapy, step 2 : radiofrequency ,step 3 : lymphatic drainage.)
DETAIL: 10 adult female volunteers in several European countries, with BMI (Body Mass Index) of less
than 30, ranging from 32 to 55 years of age with grade II - III cellulite according to the Nurnberger and
Muller classification system (1) received 4 monthly treatments in the upper thighs, buttock and
abdomen during a 4 months period, with the New LIPOKONTUR™ system (Carismed GmbH, Germany)
and were evaluated at intervals during the 4 months period.
The program consisted of step-by-step sequential treatments, following an innovative protocol named
“SHYLD™” for Shock, Hyperthermia and Lymphatic Drainage. Each treatment combined a three-step
session, the first, a Radial Acoustic Wave Treatment (RSWT) – the “Shock”, immediately followed by a
second step using Radio-Frequency (RF) energy –the “Hyperthermia” and ending with a third step of
RSWT for an energetic “Lymphatic Drainage”.
This informal study evaluated the efficacy and safety of a new and advanced SHYLD™ Concept (Shock,
Hyperthermia , Lymphatic Drainage) protocol using a LIPOKONTUR™ device, which generates
alternatively either acoustic shockwaves in multiple therapeutic profiles and/ or Multipolar RF energy
for the treatment of upper thighs, buttocks and abdomen cellulite, love-handles, circumferential
reduction and the treatment of stretch marks. There were three discrete and successive stages for each
treatment session.
In the FIRST stage, RSWT was used to mechanically weaken and loosen the stiffened/ hardened septae
of connective tissues holding the fat cells, improving elasticity, and to increase the permeability of the
fat cells’ membranes, concurrently increasing blood and lymph circulation.
In the SECOND stage, deep dermal RF heating using the “waving frequencies” proprietary method of
the LIPOKONTUR™ was used to liquefy the weakened fat cells and promote neo-collagenesis, tightening
the overlying skin over long term and leading to reduction of cellulite and stretch marks.
3. COMBINED TECHNIQUES TO PERFECT THE BODY – LIPOKONTUR™:
COMBINING SHOCKWAVE/RADIO-FREQUENCY USING THE SHYLD™
PROTOCOL
(Abstract)
In the THIRD stage, RSWT was used again to enhance the drainage of lipids resulting from the
breakdown of fat cells and to remove excess debris and fluids into the vascular and lymphatic system.
Each volunteer received up to 4 courses of RSWT and MultiPolar RF treatment during a 4-month period
following the advanced SHYLD™ standardized protocol. Independent evaluators measured treatment
efficacy with pre and post circumference measurements and evaluation of photographs using a 0-4 scale
system (0=no improvement , 1=minimal , 2= mild, 3= moderate, 4=significant improvement) .
The volunteers self-reported their overall satisfaction post treatment. Assessment of cellulite
improvement and degree of reduction of skin laxity and stretch marks also included the review of a
series of photographs for each subject at baseline, 6 weeks, 3 months and 4 months or thereabout.
These photographs were separately scored by independent observers, and potential adverse effects
were also observed and recorded.
RESULTS:
RESULTS : visible 3 months later, similar to liposuction. This smooth technique allows to eliminate 30% of fatty
tissue gradually.
Discussion of the Preliminary Results
Independent evaluators assessed circumference measurements and photographs using a 0-4 scale system (0
= no improvement, 4 = significant improvement) pre and post RSWT and RF treatments. These showed
progressive improvement of cellulite scores in several of the volunteers at the 3-month follow up, with a score
of at least two points, while in couple of them a score of one point was noted.
In addition, a noticeable reduction in circumference measurements was observed both at the levels of the
upper thighs and of the abdomen.
After 4 treatments, almost all volunteers showed an improvement in skin roughness, elasticity, elevations and
depressions.
Observation at various intervals during the next three months following the final treatment showed that all
analytic measurements were real improvements and not just an immediate effect of the generated acoustic
shockwaves or heat alone.
In average, the analyses show improvement in skin roughness, elasticity, elevations and depressions in all
patients after the program of 8 treatments.
4. COMBINED TECHNIQUES TO PERFECT THE BODY – LIPOKONTUR™:
COMBINING SHOCKWAVE/RADIO-FREQUENCY USING THE SHYLD™
PROTOCOL
(Abstract)
A large percentage of treated subjects reported being satisfied or very satisfied with the degree of cellulite
reduction and/or striae improvement, with tighter skin.
A few had a neutral opinion with the degree of cellulite reduction and noticed only mild changes of skin texture.
The most common adverse reaction was a transient mild erythema and minor bruises / contusion in areas with
striae. This reaction was noted in some of patients and lasted for a few hours to several days. No major
complications were reported on the sample treated.
All volunteers who completed this informal course of SHYLD™ Therapy with the LIPOKONTUR™ dual RSWT
/multipolar RF were followed up during and at different post treatment points. All had a measured Body Mass
index (BMI) of less than 30 (average BMI of 26).
All RSWT and RF treatments following the SHYLD™ protocol were well tolerated by patients with a pain scale
range which seemed to fluctuate between a 3-5 on a scale of 0-10. No topical anesthesia or sedation was
needed for any of the volunteers. All described mostly a feeling of tolerable mild to moderate shock and/or heat
sensation caused by the various probes during the treatment.
Of the 10 female volunteers who participated in this informal trial, most had a grade III cellulite, while a few had
grade II cellulite. All of them had some degree of stretch marks, mostly at the level of the abdominal and upper
thighs areas. None of them had any major health problems or any underlying skin disorders. None of them had
any past history of previous cosmetic surgical procedures such as abdominal lipectomy and/or liposuction.
Independent evaluators assessed circumference measurements and photographs using a 0-4 scale system (0
= no improvement, 4 = significant improvement) pre and post RSWT and RF treatments. These showed
progressive improvement of cellulite scores in several of the volunteers at the 3-month follow up, with a score
of at least two points, while in couple of them a score of one point was noted.
In addition, a noticeable reduction in circumference measurements was observed both at the levels of the
upper thighs and of the abdomen.
After all 4 treatments, almost all volunteers showed an improvement in skin roughness, elasticity, elevations
and depressions.
Observation at various intervals during and following the final treatment showed that all analytic measurements
were real improvements and not just an immediate effect of the generated acoustic shockwaves or heat alone.
In average, the analyses show improvement in skin roughness, elasticity, elevations and depressions after 4
treatments.
A large percentage of treated subjects reported being satisfied or very satisfied with the degree of cellulite
reduction and/or striae improvement, with tighter skin.
A few had a neutral opinion with the degree of cellulite reduction and noticed only mild changes of skin texture.
5. COMBINED TECHNIQUES TO PERFECT THE BODY – LIPOKONTUR™:
COMBINING SHOCKWAVE/RADIO-FREQUENCY USING THE SHYLD™
PROTOCOL
(Abstract)
The most common adverse reaction was a transient mild erythema and minor bruises / contusion in areas with
striae. This reaction was noted in some of patients and lasted for a few hours to several days. No major
complications were reported on the sample treated.
There were no scarring, bruising, dysesthesia, or asymmetries noted in any of the volunteers.
CONCLUSIONS :
CONCLUSIONS : safe , effective and well tolerated non-invasive procedure ; Ideal alternative to liposuction
in some cases .
DISCUSSION OF THE CONCLUSION
The new, versatile, cost effective, and non-invasive therapy we call the SHYLD™ Concept implemented
on the LIPOKONTUR™ system combining both Radial shockwaves energy and multi-frequencies (1, 0.75,
0.5 Megahertz) Multipolar RF delivery system seems to be an effective and safe therapy which produces
an objective and subjective reduction in cellulite, with notable skin tightening, improvement of
elasticity, smoothing and reduction of roughness in striae with acceptable epidermal safety.
These changes seem to confirm a cellulite fat breakdown and dermal wound healing process in response
to the symbiotic and complementary effects of both acoustic shockwave and mild hyperthermia induced
by RF energy.
In addition, since each of these energy sources (RSWT and/or RF) may be used separately, the
LIPOKONTUR™ applications may be extended to the management of facial/neck wrinkles, and body
contouring and skin tightening after liposuction, VASER™ treatment or pregnancy – as demonstrated in
other studies of either technology.
This 4 months, informal, pilot clinical study is pointing to the effectiveness and safety of this new,
versatile, non-invasive SHYLD™ Therapy as implemented on the LIPOKONTUR™ system which includes
Dual Radial Shock Wave Therapy (RSWT) combined with a multipolar RF, and used for the treatment of
grade II-III cellulite, circumference reduction, and skin tightening of the upper thighs, buttocks and
abdomen.
Repeat RSWT and RF treatments are feasible and appear to generate a synergistic effect. The treatments
are well tolerated with no anesthetics with negligible adverse effects and no long-term complications.
The 4 months cosmetic results are promising and future studies with adjustment of treatment settings
6. COMBINED TECHNIQUES TO PERFECT THE BODY – LIPOKONTUR™:
COMBINING SHOCKWAVE/RADIO-FREQUENCY USING THE SHYLD™
PROTOCOL
(Abstract)
may further improve the clinical results. These preliminary observations are also showing improvements
in body contouring and stretch marks but these need to be quantified and further observed and
measured.
In addition, the compact nature, cost effectiveness and versatility of this device combining both the
technologies of Radial Shock Wave Therapy and Radio Frequency are making it very attractive in today's
health care system and aesthetic surgery.
A more formal pilot study is in the works and its results need to confirm the ones reported here.
Too, scientifically designed studies including more subjects and a longer follow up should be
implemented and should further confirm the effectiveness and elegance of the SHYLD™ Therapy
concept and of the LIPOKONTUR machine.
PREPARED FOR PRESENTATION, 6th
5CC, Aesthetic and Laser Medicine
Cannes, September 3-6, 2015
CARISMED GmbH