AQUALYX - Cosmedical Solutions · intravenous infusion for the treatment of intravascular fat ......

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Transcript of AQUALYX - Cosmedical Solutions · intravenous infusion for the treatment of intravascular fat ......

AQUALYX LIPOSUCTION WITH-OUT THE USE OF

SCALPELS

NON SURGICAL REDUCTION OF LOC ALIZED FAT DEPOSITS

INTRALIPOTHERAPYAQUALYX

Contents

1. Historical review

2. Composition

3. Mode of action

4. Histological evidence

5. Clinical evidence

6. Indications

7. Contra-indications

8. Safety data

9. Protocol of injection

10. Pricing recommendation

11. before & after Photo-Gallery

12. Medical training and intralipotherapycourse

1. Historical review of non surgical treatments

past

• Meso-therapy

• Electro-lipolyse

• O2O3-therapy

Recent past

• Ultrasound “cavitation”

• Phosphatidylcholine preparations

present

• Laserlysis

• Aqualysis “Intralipo-therapy”

• Cryo-lipolysis

Phosphatidylcholine ,Misconception and calrification“ Lipostabil _ Lipolight _ Lipodisolve _ Lipolyse _ Lipomelt _ Flabjap”

COMPOSITION

Phosphatidylcholine

Sodium deoxycholate

Benzilic alchol

Tocopherol

saline

MISCONCEPTION

Phosphatidylcholine as active ingredient.

Lipolysis as functional activity.

Meso-therapy as injection technique.

CLARIFICATION

Deoxycholate as active ingredient.

Adipocytolysis as functional activity.

Intralipo-therapy as injection technique.

Phosphatidylcholine“lipostabil”

• On 1966 , germany approve the use of lipostabil(5% phosphatedylcholine , 4.75% deoxycholate) as intravenous infusion for the treatment of intravascular fat embolism, dyslipidemia and liver cirrhosis).

• Few years later, a growing trend of off-label usage of lipostabil in reduction of infra-orbital fat without any clinical evidence.

• Few years later, many generics to lipostabil introduced commercially to the market under different names such as: lipodissolve , lipolight , lipolyse.

• 2010, FDA take restrictive action against these formulations which used for the treatment of localized adiposity after increasing reports of permanent scarring , skin deformations , deep painful nodules.

• Now, phosphatedylcholine is totally banned in Europe.

2. AQUALYX Composition

aqueous micro-gelatinous solution containing a polymer of

3:6-anhydro-l-galactose and D-galactose, buffer systems,

3,12-Dihydroxy-5-24-oico Cholanic Acid sodium Salt, physiologic solution

2. AQUALYX Composition cont.,

• Aqueous micro gelatinous solution with a slowly released, short half life time, biocompatible, fat selective and re-absorbable system of modified detergent compound; “ sodium deoxycholate”.

• The adipocytolytic action is enhanced by associated use of external ultrasound.

• AQUALYX must be injected exclusively and only by lipoinject needles with an injection technique called intralipotheraby .

3. AQUALYX mode of action

• The biocompatible , short half life time , highly selective sodium deoxycholate _without PC_ selectively destroy fat cell membrane initiating the process of adipocitolysis and liberating:

1. the water “absorbed by blood vessels and then excreted through urine”

2. triglycerides “ absorbed by lymphatic drainage system toward the liver where it excreted through stools”.

3. AQUALYX mode of action cont.,

Sodium Deoxycholate’s biocompatibility

DC is endogenous bile salt ,in the same time a compatible detergent

….. HOW !!?• Metabolically inert

• Excreted in same formula in which they are administrated

• Tissue specific activity

3. AQUALYX mode of action cont.,

Sodium Deoxycholate’s fat selectivity

DC preferentially targets fat tissue while sparing non fat tissues ... ….. WHY !!!?

• Albumin is a physiological protein, show very high affinity to Deoxycholate , bind to DC forming inactive complex ,absorbed by blood vessels, carry DC. to liver where it rejoins the endogenous bile acid pool.

• Albumin physiological levels in adipose tissue is 0.7% while 1.3% in muscle tissue & 4% in plasma “the sufficient level to completely deactivate the instantly cytotoxic level of DC.”.

• The physiological conc. of albumin in protein rich tissues such as “skin , muscles , vessels and plasma” deactivates DC-mediated cell lysis , while protein poor tissues “fat” is highly sensitive to DC. Cause of low albumin level.

• The rapid neutralization of DC. Into DC-albumin inactive complex , rapid absorption prevents DC. From accumulation in injection site and produces extensive tissue lysis.

3. AQUALYX mode of action cont.,

Sodium Deoxycholate’s fat selectivity

4. AQUALYX Histological Evidence

Histological studies performed ex-vivo show how AQUALYX is capable of producing adipose tissue alterations such as :

• Rupture of fat cell wall

• Homogenization of cytoplasmic vacuoles

• Liberation of triglycerides

A_ normal adipose tissue.

B_1% DC treated adipose tissue.

C_ foamy macrophages “grey arrows”.

D_ free lipid droplets “blue arrow” & remnants of

destroyed adipocytes “black arrow” .

4. AQUALYX Histological Evidence cont.,

Histological section under high power electronic microscope

INTRALIPOTHERAPY

5. AQUALYX clinical evidences

• Dr.Raffaele Rauso

• Dr.Antonio Rusciani

• Dr.Giuseppe CuringaAUTHOR

• Maxillo-Facial Surgery ,Centro Polispecialistico Santa Apollonian, Italy.

• University Of Foggi, Foggia , Italy.

• Department Of Plastic Surgery, La Sapienza, University Rome, Italy.

• Skinlaser, Plastic Surgery Center, Rome, Italy.

• Venuslab, Plastic Surgery Center, Rome, Italy.

LOCATION

• Journal Of Drugs In Dermatology , October2014, Volume 13 , Issue 10.

• Dr.raffaele rauso……………………………Dr.raffaelle.rauso@gmail.com.

PUPLICATION

&

Author

correspondence

5. AQUALYX clinical evidences CONT.,

•Dr. Hernan Pento

•Dr. Carlota Hernandez

•Dr. Cinara Turra

•Dr. Marisa Manzano

•Dr. Laura Salvador

•Dr. Paloma Tejero

AUTHOR

• Instituto de Investigaciones para las Especialidades Esteticas y del Envejecimiento , Barcelona , Spain.

• Clinica Arts Medica, Valencia, Spain.

• Beyou Medical Group, Malaga, Spain.

• Antiaging Group, Barcelona, Spain.

• Clinica Mediestetic, Toledo, Spain.

LOCATION

• Journal Of Drugs In Dermatology , December 2014, Volume 13 , Issue 12.

• Dr.Hernan Pento……………………………………………...hpinto@ageback.es

PUPLICATION

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Author Correspondence

5. AQUALYX clinical evidences CONT.,

• Dr. Giovanni Salti.

• Dr. Pasquale Motolese.AUTHOR

• Instituto Medilight, Florence, Italy.

• Professor FORMEST university of ferrara, Italy.LOCATION

• The European Journal of Aesthetic Medicine and Dermatology, Feb. 2012.

• Dr. Giovanni Salti…………………………..giosal@fol.it.

PUPLICATION

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Author Correspondence

5. AQUALYX clinical evidences CONT.,

• Dr. Hernan Pinto

• Dr. Graciela Melamed

• Dr.Luca Fioravanti

AUTHOR

• Age back, Barcelona

• MEG Group, Buenos Aires

• Thermalift Centre, PaviaLOCATION

• The European Journal of Aesthetic Medicine and Dermatology, Feb. 2012.

• Dr.Hernan Pento………………………………….…………...hpinto@ageback.es.

PUPLICATION

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Author Correspondence

5. AQUALYX clinical evidences CONT.,

• Dr. Raffaele RausoAUTHOR

• Consultant Aesthetic & Maxillo-Facial Surgery, Centro Polispecialistico Santa Apollonia, S.M.C.V (CE), ItalyLOCATION

• The European Journal of Aesthetic Medicine and Dermatology, Jan. 2011.

• Dr.Raffaele Rauso………………………….…………...raffaelerauso@virgilio.it.

PUPLICATION

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Author Correspondence

5. AQUALYX clinical evidences CONT.,

• Dr. El Kamshoushy A.

• Dr. Adel Maksoud R.

• Dr. El Mahdy N.

AUTHOR

• Department of Dermatology , Venereology and Andrology , Faculty of Medicine , University of Alexandria , Egypt. LOCATION

• Journal of Clinical and Experimental Dermatology Research , 2012 Volume 3 Issue 2.

PUPLICATION

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Author Correspondence

5. AQUALYX clinical evidences CONT.,

• Dr. Rattapon Thuangtong

• Dr. Jason J. Bentow

• Dr. Kristeene Knopp

• Dr. Nader A. Mahmood

• Dr.Nathaniel E. David

• Dr. Michael S. Kolodney

AUTHOR

• Department of Dermatology , Harbor-University of California at Los Angeles Medical Center and Los Angeles Biomedical Research Institute , Torrance , California.

LOCATION

• the American Society for Dermatologic Surgeries , 2010 , Published by Wiley Periodicals Inc..

• Dr. Michael S. Kolodney……………………………………………………..mkolodney@labiomed.org..

PUPLICATION

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Author Correspondence

5. AQUALYX clinical evidences CONT.,

• Dr. Adam M. RotundaAUTHOR

• Department of Dermatology , Harbor-University of California at Los Angeles Medical Center and Los Angeles Biomedical Research Institute , Torrance , California.

LOCATION

• the American Society for Dermatologic Surgeries , 2009 , Published in Dermatologic Surgery May 2009 Volume 35 Issue.

PUPLICATION

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Author Correspondence

5. AQUALYX clinical evidences CONT.,

• Dr. Roberto Amore

• Dr. Kostas Gritzalas

• Dr. Domenico Amuso

• Dr.Loredana Tanzarella

• Dr. Vincenza Leonardi

AUTHOR

• Department of Dermatology , University of Palermo , Italy . LOCATION

• the European Journal of Aesthetic and Dermatology , Dec. 2015 Volume 3.

• Dr. Roberto Amore…………………..robertoamore@Hotmail.com.

• Dr. Kostas Gritzzalas…………………….kostas.gritzalas@yahoo.com.

PUPLICATION

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Author Correspondence

6. AQUALYX Indications

• The best results can be obtained in patients with an average body weight or slightly over weight with local accumulation of fat , AQUALYX not indicated for obese patients .

• Same as liposuction target areas ; “over the knee, under the jaw” .

• Indicated areas are :

1. Buffalo hump

2. Sub mental fat “double chin”

3. Knee fat

4. Humero tricipital fat “arm fat”

5. Pseudo gynecomastia

6. Inner & outer thighs

7. Thoracic folds

8. Love handles “bananas”

9. Abdomen

10. Culottes de cheval

7. AQUALYX Contraindications

1. Pregnant and breast feeding woman.

2. Auto-Immune diseases.

3. Serious systemic diseases “kidney , hepatic failure”.

4. Acute or chronic pathologies in the skin of treated area.

5. Positive history to anaphylactic reaction.

8. AQUALYX Safety data

• AQUALYX is registered as medical device “ class 3 medical device CE0373” for the reduction of localized adipose deposits through the use of intralipotherapy technique.

• Sold in more than 50 countries worldwide including : UK , RUSSIA , GERMANY , SPAIN , ITALY , GREECE , ….

• Locally registered in GCC .

9. AQUALYX & Intra lipotherapy

9. AQUALYX protocol of injection

• No dermal and muscular tissue involvement ( safe ).

• Rapid .

• Non painful .

• Limited number of injections .

• Secure (selective)

9. AQUALYX protocol of injection cont.,

• Patient measurements

All patients measurements and zones marking should be done on upright stand position.

• 3 Dimensional Dose calculation

Tota

l do

se If skin pinch test less than 3 cm

One vial for each 100 cc

Example: area of 25 cm * 10 cm = 250 cc “needs 2.5 vials”

If skin pinch test more than 3 cm

One and half vial for each 100 cc

Example: area of 25 cm* 10 cm = 250 cc “needs 3.75 vial”

9. AQUALYX protocol of injection cont.,

• Maximum dose per areaT h e t o t a l i n j e c t e d d o s e s h o u l d n o t e x c e e d 6 v i a l s / t r e a t e d a r e a .

• Maximum dose per session T h e t o t a l i n j e c t e d d o s e s h o u l d n o t e x c e e d 6 v i a l s / s e s s i o n , i n c a s e o f i n j e c t i o n o f m o r e

t h a n o n e a r e a i n t h e s a m e s e s s i o n .

• Level of injectionT h e i n j e c t i o n m u s t b e d o n e i n t h e d e e p f a t t i s s u e n o t s u p e r f i c i a l ; w h e r e t h e p h y s i c i a n c a n n o t v i s u a l l y r e c o g n i z e t h e n e e d l e u n d e r t h e s k i n s u r f a c e .

• Injection techniqueT h e i n j e c t i o n t e c h n i q u e i s r e t r o g r a d e f a n n i n g t e c h n i q u e ; w h e r e t h e p h y s i c i a n i n j e c t t h e m a t e r i a l w h i l e w i t h d r a w t h e n e e d l e b a c k w a r d l y .

9. AQUALYX protocol of injection cont.,

• Infiltration rate T h e i n f i l t r a t i o n r a t e o f t h e i n j e c t i o n i s 0 . 3 m l i n e a c h s i n g l e p a s s o f t h e n e e d l e i n s i d e t h e

f a t t i s s u e ; w h e r e t h e p h y s i c i a n s h o u l d d o 2 4 p a s s e s a p p r o x i m a t e l y p e r e a c h v i a l .

• Lidocaine anesthesiaA d d 0 . 3 m l o f l i d o c a i n e 2 % f o r e a c h A Q U A LY X v i a l “ 8 m l ” , i m m e d i a t e l y b e f o r e t h e

p r o c e d u r e a n d w e l l m i x t h e c o m b i n a t i o n .

• Sessions intervalT h e r e c o m m e n d e d s e s s i o n ’ s i n t e r v a l i s 2 1 d a y s .

• Sessions interval for a new treated areaT h e r e c o m m e n d e d s e s s i o n ’ s i n t e r v a l i s 1 0 d a y s .

9. AQUALYX protocol of injection cont.,

• Required number of treatment sessions T h e n u m b e r o f t r e a t m e n t s e s s i o n s i n t h e s a m e t r e a t m e n t a r e a d e p e n d s o n t h e f a t v o l u m e . To a c h i e v e t h e d e s i r a b l e r e s u l t s 4 t r e a t m e n t s a r e r e q u i r e d .

• Result evaluationT h e f i r s t r e s u l t e v a l u a t i o n c a n b e c a r r i e d o u t a f t e r 4 2 d a y s f r o m t h e f i r s t t r e a t m e n t ;

“ o n t h e d a y o f t h e t h i r d s e s s i o n ”.

• After treatment symptomsT h e t y p i c a l s y m p t o m s o f t h e t r e a t m e n t a r e e d e m a a n d l i g h t b r u i s i n g , t h e s e s y m p t o m s

w i l l s u b s i d e i n l e s s t h a n 5 d a y s , h o w e v e r , t h e p a t i e n t s c a n r e t u r n t o t h e i r d a i l y r o u t i n e

j u s t a f t e r t h e t r e a t m e n t s e s s i o n w i t h z e r o d o w n t i m e .

• Aqualyx side effectsI n c a s e t h e t r e a t m e n t i s n o t p e r f o r m e d c o r r e c t l y , a n d t h e i n i n f i l t r a t i o n i s s u p e r f i c i a l a

p a i n s e n s a t i o n a n d e r y t h e m a w i l l o c c u r. H o w e v e r n e c r o s i s h a s n e v e r o c c u r r e d .

9. AQUALYX protocol of injection cont.,

• Recommendations• P r e s s - t h e r a p y• Ly m p h a t i c d r a i n a g e• C a r b o x i - t h e r a p y

• Recommended supplements• A m i n o a c i d s• C a r n i t i n e

• Contra- indicated procedures “4 days after treatment”• R a d i o - f r e q u e n c y• C r y o - l i p o l y s i s• O t h e r k i n d s o f m a s s a g e• P h y s i c a l i n t e n s e a c t i v i t y

• Expected results• I n d o u b l e c h i n , e x c e l l e n t r e s u l t s o b t a i n e d f r o m o n l y o n e s e s s i o n .• I n s m a l l a r e a s , e x c e l l e n t r e s u l t s o b t a i n e d q u i c k l y f r o m f e w s e s s i o n s .• I n l a r g e a r e a s , s a t i s f a c t o r y r e s u l t s “ 2 _ 5 c m r e d u c t i o n ” w i t h t h e f i r s t s e s s i o n , h o w e v e r , t h e

p a t i e n t s h o u l d c o m p l e t e t h e t r e a t m e n t c o u r s e ( 4 _ 6 s e s s i o n s ) t o o b t a i n e x c e l l e n t r e s u l t s .

9. AQUALYX protocol of injection cont.,

• Injecting needle “ lipoinject”

• Specifically designed for intralipotherapy technique. made of top

quality German steel, guarantee a painless and easy penetration and

size defined by a specific study of flows to a selective and

homogeneous infiltration.

• Available in two versions for the treatment of small and large areas of

the body “25G/70mm” & “25G/100mm” respectively.

10. AQUALYX pricing recommendations ,

• t h e p r i c i ng s ys t em s h oul d be on t h e ba s i s of t h e s i ze of t h e t r ea t ed

a r ea n o t t h e n umber o f t h e i n ject ed v i a l s .

Double chin

• The session charge : 350 _ 450 dollar # 1250_1600 aed / session.

• The clinic cost : (½ _ 1 vial) (1 _2 sessions) = 20_40 dollar # 70 _150 aed /session

Small areas

• The session charge: 400_500 dollar # 1500_ 1800 aed /session.

• The clinic cost : (1_3 vials) (2_4 sessions) = 40_120 dollar _ 150_450 aed / session.

Large areas

• The session charge: 550_700 dollar # 2000_ 2500 aed / session.

• The clinic cost : (3_6 vials) (4_6 sessions) = 160_240 dollar # 575 _ 860 aed / session.

AQUALYX Photo-Gallery

ABDOMEN 3 SESSIONS _ 4 VIALS / SESSION

ABDOMEN 3 SESSIONS _ 4 VIALS / SESSION

ABDOMEN 3 SESSIONS _ 4 VIALS / SESSION

ABDOMEN 5 SESSIONS _ 4 VIALS / SESSION

ABDOMEN 5 SESSIONS _ 4 VIALS / SESSION

ABDOMEN 5 SESSIONS _ 4 VIALS / SESSION

Bananas 3 SESSIONS _ 3 VIALS / SESSION

Pseudo-gynecomastia 3 SESSIONS _ 3 VIALS / SESSION

Back rolls 2 SESSIONS _ 6VIALS / SESSION

Back rolls 2 SESSIONS _ 6VIALS / SESSION

Back rolls 4 SESSIONS _ 4VIALS / SESSION

Back rolls 4 SESSIONS _ 3VIALS / SESSION

Thighs 4 SESSIONS _ 4VIALS / SESSION

Thighs 3 SESSIONS _ 6 VIALS / SESSION

Thighs 5 SESSIONS _ 4 VIALS / SESSION

Thighs 5 SESSIONS _ 4 VIALS / SESSION

Thighs 6 SESSIONS _ 4 VIALS / SESSION

Thighs 5 SESSIONS _ 4 VIALS / SESSION

Thighs 5 SESSIONS _ 4 VIALS / SESSION

Thighs 4 SESSIONS _ 4 VIALS / SESSION

Thighs 1 SESSION _ 4 VIALS / SESSION

Thighs 6 SESSIONS _ 4 VIALS / SESSION

Double chin 3 SESSIONS _ 1 VIAL / SESSION

Double chin 3 SESSIONS _ 1 VIAL / SESSION

AQUALYX

AQUALYX

AQUALYXThe Medical Advisor and Trainer

Dr. Gkritzalas konstantinos• Dermatologist, University of Bologna, Italy.

• Opinion Leader & Certified Trainer Greece, Turkey, ΕΜΕΑ,Russia , GCC.

kostas.gritzalas@yahoo.com

AQUALYX

THANKS !