WHEN FRENCH TOUCH MEETS BEAUTY - Hyaluronic Acid … · 2017-05-24 · When French touch meets beauty. ... Evaluation and comparison study of the G’ rheologi-cal properties of PERFECTHA®

WHENFRENCHTOUCHMEETSBEAUTY

When French touch meets beauty

PERFECTHA® is manufactured 100% in France by SINCLAIR PHARMA in its laboratory specialized in the research, development and manufacturing of Hyaluronic Acid (HA) dermal fillers, and ISO 13485 certified since 2007.

The biocompatibility and performance of the entire PERFECTHA® range have been clinically demonstrated. PERFECTHA® complies with all safety standards required by health authorities and has been CE marked since 2007. It is registered and launched in more than 70 countries around the world.

With more than 10 years of clinical use, 2.8 million syringes sold worldwide, PERFECTHA® has established itself among the leaders on the aesthetic market.

PERFECTHA®,MADE IN FRANCE BY SINCLAIR


PERFECTHA® IS A TAILOR - MADE RANGE OF

1 - Perfectha is intended for reconstructive purposes in the treatment, for instance, of facial lipoatrophy, or morphological asymmetry associated with the aging process or other underlying conditions. Perfectha is for intradermal and subcutaneous application and is implanted in the areas of the face and hands to fill skin depressions and also for the augmentation of tissue volume.

« MADE IN FRANCE » HA DERMAL FILLERS,

DESIGNED FOR WRINKLE CORRECTION, FACIAL CONTOURING AND VOLUME RESTORATION,

COMBINING EASE OF INJECTION

AND NATURAL AND LONG-LASTING RESULTS.1

PE

RF

EC

TH

A®

/ 0 3


THE E-BRID TECHNOLOGY: A STATE OF

Use of high molecular weight and

high purity Sodium Hyaluronate

ENHANCED CROSS-LINKING

PROCESS

Elimination of impurities

1

2

3

ENHANCED CROSS-LINKING PROCESS

Microgel Particles

The Macromolecular Network is maintained

in the resulting microgel particles.

Free HA Macromolecular Network

BDDE

CROSS-LINKINGPARTICLE CREATION

+

2

RANGE OF FILLERS


THE ART MANUFACTURING PROCESS

CONTROLLEDMIXING PROCESS

Standardized pharmaceutical

grade sterilization

Extensive quality control

4

5 6

CONTROLLED MIXING PROCESS

Microgel particles

HA Polymer Solution Network

CONTROLLED MIXING

MULTI STRUCTURED CONNECTIVE NETWORKS

+

PE

RF

EC

TH

A®

/ 0 5

4

RANGE OF FILLERS


MULTI-STRUCTURED CONNECTIVE NETWORKS

FEATURES BENEFITSBENEFITS FOR PATIENTS

Use of high quality, high molecular weight Sodium Hyaluronate

� Product with a high safety rating� Tolerance� Safe use

� Ensures coherent flow and ease of injection

� Lifting and volumizing effect

� Slows down the gel degradation process

� Slows down the gel degradation process

� Antioxidant effect

� Confers mobility to the microgel particles and thus ensures coherent flow and ease of injection

� Instant volumizing effect� Filled cutaneous depressions

� Better / healthier looking� Longer-lasting results

� Longer - lasting results

� Slows down the skin degradation process

� Less painful

� Low risk of adverse events

� Less painful

PURE GEL

RESILIENT MICROGEL NETWORKS

CREATES A PROTECTIVE FLUID ENVIRONMENT

PROVIDES BRIDGES BETWEEN NETWORKS

Degree of cross-linking

HA Polymer Solution Network

Interfacial Network

MACROMOLECULAR NETWORKA combination of both physical and chemical bonds leading to a strong cross-linked network.

HA POLYMER SOLUTION NETWORKPhysical network made of entangled HA chains. It is a soft solution.

INTERFACIAL NETWORK This interfacial network is created by the presence of entanglements between the outer region of the microgel particles and the neighbouring HA.

PE

RF

EC

TH

A®

/ 0 7


No significant cytotoxicity3

OPTIMAL GEL CHARACTERISTICS

PERFECTHA® complies with safety standards for dermal fillers2. It is a non-cytotoxic product3 and proves to be a biologically safe product2.

CTL

S A F E T Y

PERFECTHA® is made of cross-linked hyaluronic acid gel of non-animal origin at a concentration of 20 mg/ml in phosphate-buffered saline.

Non-detectable BDDE residual content

< 2 ppm

Low Endotoxin level

< 4 UI / ml ( routinely < 0.5 UI/ml )

Low Protein Load

< 6 µg / ml

1:4 DILUTION NO DILUTION1:2 DILUTION

Relative Cell Viability (%)

PERFECTHA® showed greater than 90% cell viability3.Cell toxicity was tested on fibroblast cell line. Cell viability was assessed neat and in 1/2 and 1/4 dilutions using 0.2g/ml HA filler.

References : 2- Technical file3- Park KY1, Kim HK, Kim BJ. Comparative study of hyaluronic acid fillers by in vitro and in vivo testing. J Eur Acad Dermatol Venereol. 2014 May;28(5):565-8.

JUVEDERM ULTRA-XC PERLANE® PERFECTHA DEEP ®

0%

20%

40%

60%

80%

100%


0.018 % adverse events5

PERFECTHA is devoid of

inflammatory effect4

References : 4- Koenig B., Analysis of IL-8 inducing potential from human effector cells. Evaluation of inflammatory potential of Perfectha product line by measurement of IL-8 release from adherent macrophages. Study Report, MMD, May 2016.5- Post-market survey from July 2012 to June 2016

PE

RF

EC

TH

A®

/ 0 9

2.8 million syringes sold worldwide and a very low adverse event rate.

PERFECTHA® products were tested on adherent macrophages and induced a very low release of IL - 8 (specific mediators of inflammation), around 50 pg / ml, evidencing that the products are devoid of inflammatory effect4.

120000,00

STIMULUS

IL-8

[pg/

ml]

100000,0080000,0060000,0040000,00

20000,000,00

Lps 1 µg/ml100944,48

Lps 100 ng/ml49598,48

Lps 10 ng/ml17614,98

Lps 1 ng/ml5296,16

LPS : positive controle4

Dilution of hyaluronan filler4

IL-8

[pg/

ml]

1:2

50

1:4 1:8 1:16 1:32 1:64 1:128 1:256

PERFECTHA® COMPLEMENT

PERFECTHA® DEEP

PERFECTHA® DERM

PERFECTHA® SUBSKIN


References : 6- Talarico S. et al. Evaluation of the safety and efficacy of a new filler with hya-luronic acid for the treatment of nasolabial folds and lip contour; Surg. Cosmet. Dermatol.2010;2(2):83-67- Park KY1, Kim HK, Kim BJ. Comparative study of hyaluronic acid fillers by in

vitro and in vivo testing. J Eur Acad Dermatol Venereol. 2014 May;28(5):565-8.8- Da Costa et al. Durability of Three Different Types of Hyaluronic Acid Fillers in Skin: Are There Differences Among Biphasic, Monophasic Monodensified, and Monophasic Polydensified Products?; Aesthet. Surg. J. 2016, 1-9

Studies conducted on PERFECTHA® Derm evidenced that 86% of patients showed « much improved » and « very much improved » appearances one week after treatment, according to the Global Aesthetic Improvement Scale (GAIS). Moreover, they proved that filling effects last even after 6 months as excellent results remained in the nasolabial folds in 57% of the patients, and in the lips in 45%6.

E F F I C I E N C Y

L O N G L A S T I N G

Degradation rate in vitro7 (%)

Reduction rate in vivo in humans at 6 months8 (%)

50% 40% 79%

86% much improved and very much improved

appearances 6

PERFECTHA ®

DERMTEOSYAL®

GLOBAL ACTIONESTHELIS®

BASIC

PERLANE® PERFECTHA DEEP ®

JUVEDERM®

ULTRA-XC

86% much improved and very much improved

appearances 6

25% 12.5% 62.5%

The E-BRID Technology enables the presence of a higher number of covalent bonds which help to minimize the effects of hyaluronidase and oxidation in the body, thus slowing down the enzymatic degradation and allowing the gel to stay longer in the skin7.8. The HA Polymer Solution network acts as a protective environment also slowing down the gel degradation process.

Perc

enta

ge o

f sat

isfa

ctio

n %

100 %

90 %80 %

70 %

60 %

40 %

30 %

50 %

20 %

10 %

0 %

7 days 90 days 180 days

LIP CONTOUR

NASOLABIAL FOLD


All PERFECTHA® gels are among the most elastic on the market, making post-in jection results in terms of volume and lifting excellent9. Providing the practitioner an immediate effect, PERFECTHA® reduces the risk of overcorrection and gives the desired volume with a small amount of gel.

H I G H L I F T I N G A N D V O L U M I Z I N G C A P A C I T Y

E A S Y T O I N J E C T

9- Internal data - Evaluation and comparison study of the G’ rheologi-cal properties of PERFECTHA® with the main competitors HA-based dermal fillers. This study was conducted internally on a TA Instruments DHR-2 rheometer with a 25mm parallel-plate geometry. Frequency sweep tests were performed on samples between 0.1 and 100 rad/s

at a 1% strain in order to match the gels Newtonian Plateau and using plate-plate geometry.10- Internal Data: Material: Brookfield Texturometer CT3-4500 with a TA51 probe. Extrusion speed: 12mm/s over distance of 15mm.

10

100

1000

PE

RF

EC

TH

A®

/ 1 1G

’ mod

ulus

(Pa)

Juve

derm

Ultra

4

Juve

derm

Volu

ma

Teos

yal P

ures

ense

Firs

tlines

Teos

yal P

ures

sens

e Kiss

Belot

ero

Balan

ceRe

stylan

e Voly

me

Resty

lane

Resty

lane V

ital

Resty

lane K

ysse

Resty

lane L

yft

Art F

iller U

niver

sal

Art F

iller V

olum

ePE

RFEC

THA®

Der

m

PERF

ECTH

A® S

ubsk

inPE

RFEC

THA®

Dee

p

Juve

derm

Ultra

3Ju

vede

rm V

olbell

a

BIPHASIC VOLUMIZERExtrusion force

(Newtons)

Measurement of injectability10

MONOPHASIC VOLUMIZER

PERFECTHA® SUBSKIN

22,5

8,08,7

Thanks to its specific technology, PERFECTHA® allows a smooth injection given the low extrusion force needed to inject the gel, and the addition of HA Polymer Solution which acts as a lubricant agent. Moreover, the controlled particle size of PERFECTHA® and its thin wall needle enable the gel to have a regular flow, reducing any possible discomfort during injection.

PERFECTHA® Subskin is as easy to inject as the

reference monophasic product and 2.5 times

easier than the reference biphasic product10


A TAILOR-MADE

� Superficial facial lines and skin depressions� Periorbital lines� Perioral lines

SUPERFICIAL DERMISDEPTH OF INJECTION

INDICATIONS

PERFECTHA®

COMPLEMENT

HA CONCENTRATION

VOLUMINIZING CAPACITY

VOLUME

NEEDLES & CANNULAS

20 mg / ml

0.5 ml

2 x 30 G1/2’’ needle 2 x 30 G1/2’’ needle

0.8 ml

+

20 mg / ml

+

SUPERFICIAL DERMIS

� Superficial facial lines and skin depressions� Forehead finelines

PERFECTHA®

FINELINES


RANGE OF FILLERSPERFECTHA®

DEEPPERFECTHA®

SUBSKIN

2 x 27 G1/2’’ needle

22G x 50mm needle+ 22G x 50mm cannula

21G x 50mm needle+ 21G x 50mm cannula

1 ml1 x 3 ml3 x 1 ml

20 mg / ml

+++

20 mg / ml

++++

DEEP DERMISSUBCUTANEOUS OR SUPRAPERIOSTEAL

� Deep facial lines and skin depressions� Lip volume� Nose� Nasolabial folds� Marionette lines� Oral commissures� Cheekbones and chin moderate augmentation

� Volume creation� Facial contours� Malar areas� Chin and cheeks� Nose bridge� Hands

PE

RF

EC

TH

A®

/ 1 3

PERFECTHA®

DERM

2 x 30 G1/2’’ needle

1 ml

20 mg / ml

++

MID-DERMIS

� Medium facial lines and skin depressions� Glabellar lines� Lip contour


DIFFERENT PRODUCTS FOR DIFFERENT LAYERS

PERFECTHA® is a range of gels made of a 20mg/ml HA concentration. Each gel has the same HA concentration, however the cross-linking within each gel influences the rheological properties enabling a range of gels to be produced.

In particular, what differentiates PERFECTHA® gels is the particle size: the bigger the particles, the greater the volumizing effect, and the longer-lasting the results.

Each PERFECTHA® gel is unique and designed to best meet specific needs: depending on the treated areas, the volume needed and the depth of injection required, a different variant will be used.

Particle size

Resistance to enzymatic degradation

Volumizing capacity

+

+

+-

PERFECTHA® SUBSKIN

PERFECTHA® DEEP

PERFECTHA® DERM

PERFECTHA® DERM

PERFECTHA® DEEP

PERFECTHA® SUBSKIN

PERFECTHA® FINELINES





PERFECTHA® SUBSKIN : THE IDEAL VOLUMIZER

Be moldable, enabling you to shape your patients’ faces

Remain in place after injection

Perfectly restore or create volume, and redefine facial contours

Injection depth: Subcutaneous or Supraperiosteal

References : 11- J. Fares, A prospective study of evaluation of the results achieved with the application of PERFECTHA® Subskin, a new gel of hyaluronic acid non animal origin for malar and mental enhancement.

PE

RF

EC

TH

A®

/ 1 5

L O N G L A S T I N G R E S U L T S U P T O 1 8 M O N T H S 1 1

E L A S T I C A N D V I S C O U S E N O U G H T O :

18 months Efficacity Results according to the Physician Evaluator Aesthetic Rating

2

60%

50%

40%

30%

20%

10%

0%4 8 12

MONTHS

Perc

enta

ge o

f Sat

isfa

ctio

n %

18

Very much improved

Much improved

Improved

No change

Worse

100% of patients rated as very much improved or improved11


FULL - FACE TREATMENT CASE STUDY

ASSESSMENT

Atrophy of the fat layers above the nasolabial fat pad which increases

the nasolabial line and induces convexity of the jawline.

Valérie – 42 years oldBEFORE

Valérie – 42 years oldAFTER

Cheek bones PERFECTHA® SUBSKIN 1 ml Subcutaneous Fanning

Deep dermis Fanning

Deep dermis Retrograde

Superficial dermis

Retrograde

Mid - dermis

Deep dermis

Retrograde

Multi-bolus

0.4 ml right0.2 ml left

0.4 ml right0.2 ml left

0.6ml

0.4 ml

1.8 ml

PERFECTHA® DEEP

PERFECTHA® DEEP

PERFECTHA® DERM

PERFECTHA® DEEP


TREATED AREA PRODUCT QUANTITY INJECTION

DEPTH TECHNIQUE

Preauricular

Nasolabialfolds

Lipcommissures

Marionette lines, jawline & chin

TREATMENT GOAL

Reduce the nasolabial folds by lifting the mid face laterally.

The procedures featured were performed by Dr. Iñigo de Felipe, Dermatologist, Barcelona, Spain.


NATURAL - LOOKING RESULTS

BEFORE

BEFORE

AFTER

AFTER

Treated areas:Glabellar lines CheeksNasolabial folds

Treated areas:Bridge of the noseTip of the noseNasolabial angle

Products used:PERFECTHA® DERM 0.5 ML PERFECTHA® SUBSKIN 1 MLPERFECTHA® FINELINES 0.4 MLPERFECTHA® DERM 1 ML

Products used:PERFECTHA® DEEP 0.3 MLPERFECTHA® DEEP 0.3 MLPERFECTHA® DEEP 0.3 ML

PE

RF

EC

TH

A®

/ 1 7

Sécoura51 years old

Joseph32 years old



BEFORE

BEFORE

AFTER

AFTER

Treated areas: Cheeks Nasolabial foldsJawline

Treated areas:CheekbonesTip of the noseNasolabial foldsJawline & zygomatic area

Products used:PERFECTHA® SUBSKIN 1.5 MLPERFECTHA® DEEP 0.6 MLPERFECTHA® SUBSKIN 0.8 ML

Products used:PERFECTHA® SUBSKIN 1 MLPERFECTHA® DEEP 0.3 MLPERFECTHA® DEEP 0.8 MLPERFECTHA® SUBSKIN 2 ML

NATURAL - LOOKING RESULTS

Edwige48 years old

Antonio41 years old



PERFECTHA®

BY YOUR SIDE

� Injection technique videos� Case studies� Patient leaflets� Patient follow-up books � Waiting room video� Posters� Next visit reminders

www.perfectha.com

PERFECTHA® social networks are regularly updated with the latest information.

A C O M P L E T E S E T O F T O O L S T O S U P P O R T Y O U I N Y O U R D A I L Y P R A C T I C E

I N F O R M A T I O NP

ER

FE

CT

HA

®

/ 1 9

www.perfectha.com

SINCLAIR PHARMA Office Village, Chester Business Park

Chester, CH4 9QZUnited Kingdom

PF-D

B3-0

3201

7-A

Sinclair Pharma, has been commited to skin expertise since 1971, and more recently to the development of a safe, minimally invasive and effective portfolio of aesthetic treatments including

PERFECTHA®.

Documents

WHEN FRENCH TOUCH MEETS BEAUTY - Hyaluronic Acid … · 2017-05-24 · When French touch meets beauty. ... Evaluation and comparison study of the G’ rheologi-cal properties of PERFECTHA®