QU4650 Ellansé Practitioner Brochure_V6_DIGI

The regenerative volumising filler

1 ELLANSÉ PRACTITIONER GUIDE Model is not an actual patient.

Contents

4 Safely treating the true cause of facial ageing 1 6 Innovation for safety and optimal results 1

12 Ellansé for volume restoration and rejuvenation 14 Where to use Ellansé? 16 Patient case studies 24 High patient satisfaction

10 Beyond Hyaluronic Acid (HA) and Collagen Stimulators

26 Ellansé by Sinclair. Transforming customer confidence.

Model is not an actual patient.

2 ELLANSÉ PRACTITIONER GUIDE

3 ELLANSÉ PRACTITIONER GUIDE

Safely treating the true cause of facial ageing 1

While your patients might want a quick fix, it isn’t often the best way to achieve natural-looking and long-lasting results. But thanks to Ellansé, ® you can now offer them both; high quality, instant results and long-lasting powerful benefits.

Ellansé goes beyond simply correcting superficial lines and folds. A unique dual-action dermal filler, it also works deep under the skin to treat the real causes of facial ageing by stimulating the body’s production of natural collagen. THE SCIENCE BEHIND THE STIMULATION Combining smooth PCL microspheres with a CMC-based carrier gel 2 , Ellansé gets to work immediately, filling the areas affected by volume loss. Then, the microspheres degrade over time, leaving behind collagen structures that steadily rebuild and reshape facial contours to restore the skin’s youthful infrastructure.

A UNIQUE COMPOSITION: PCL AND CMC 1

30% Polycaprolactone (PCL) microspheres 70% Carboxymethyl Cellulose (CMC) based carrier gel

PCL chains within the microsphere

Model is not an actual patient.

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5 ELLANSÉ PRACTITIONER GUIDE

Innovation for safety and optimal results 1

Long-lasting results for sustained effectiveness

SAFETY

A UNIQUE AND SAFE COMPOSITION

Ellansé is available in two options: S and M with results lasting for 18 months and 24 months respectively,* distinguished only by the initial polymer chain length of the PCL.

From its launch in 2009, Ellansé’s excellent safety profile has been continuously reported, not only in clinical trials and vigilance surveys but also by clinical experts in daily practice. 3

S M ELLANSÉ 18 MONTHS * ELLANSÉ 24 MONTHS *

PCL

In a review of adverse events from launch to August 2022, the adverse event rate was 0.0462% - or 1 event in 2,165 syringes. 4

ADVERSE EVENT RATE BY TYPE: 4

PCL is biodegradable and bioresorbable, naturally hydrolysed by the body into CO 2 and H 2 O. 5

0.0207%

0.0032%

* Treatment effects have variable duration dependant on the variant used, practitioner injection technique, patient lifestyle and metabolic rate.

NODULES / LUMPS

HARDNESS / INDURATION

CMC

0.0008%

0.0121%

ELLANSÉ LONGEVITY OPTIONS The PCL microspheres’ unique biodegradation pattern maintains a longer effective lifetime than other dermal fillers, which start to degrade from day one.

CMC is a widely-used component classified as generally recognised as safe (GRAS). 5

INFECTION

SWELLING

S

M

0.0031%

0.0010%

CMC Effect:

INFLAMMATION

BRUISING / HAEMATOMA

PCL Microsphere Effect:

4 weeks

6 8

12 weeks

18 months 24 months

6 ELLANSÉ PRACTITIONER GUIDE

7 ELLANSÉ PRACTITIONER GUIDE

90% of patients, having undergone an Ellansé S and M treatment, had improved, much improved or very much improved results at 12 months. 6 100% of patients, having undergone an Ellansé M treatment, had improved, much improved or very much improved results at 24 months. 6 Innovation for safety and optimal results 1

Ellansé M offers immediate and sustained performance 7

• Efficacy increases notably from 1 to 3 months • Results are maintained for up to 24 months

MEAN GAIS SCORES

3

Mean GAIS score over a 24-month period. The scores increased notably from 1 to 3 months, and the scores were well maintained for up to 24 months.

2.5

2

MEAN GAIS SCORES PHYSICIAN EVALUATION 1 month 3 month 6 month 12 month 24 month 2.14 ± 0.95 2.38 ± 0.77 2.50 ± 0.76 2.45 ± 0.52 2.33 ± 0.50

1.5

1

0.5

Global Aesthetic Improvement Scale (GAIS) 3 = very much improved | 2 = much improved 1 = improved | 0 = no change | -1 = worse

0

1

3

6 MONTHS

12

24

A clinical trial by Bae et al. (2016) evaluated the safety and efficacy of forehead augmentation with Ellansé-M in combination with botulinum toxin Type A (n=58). Efficacy was assessed using physician scores from the GAIS at 1, 3, 6, 12 and 24 months post-treatment.

Investigator Evaluated Global Aesthetic Improvement Scale (GAIS) Ellansé S Ellansé M High efficacy of Ellansé-S and Ellansé-M in nasolabial fold treatment with high safety over a 2 year period 6

Proven Neocollagenesis for regenerative results

2013: 21 months post-injection (rabbit), Type I collagen confirms stable environment and long-term efficacy. 8

3.5%

5,2%

TYPE I COLLAGEN

100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0%

6%

4%

23%

7%

10%

13,8%

20%

20%

50μm

51.7%

50%

62,8%

11% 11%

55%

45%

58%

50%

71%

10%

77%

60%

78%

45%

2015: 13 months post-injection, confirmed collagen production in the human body. PCL microspheres were surrounded with collagen deposition and a mild fibroblastic and histiocytic tissue response (Martin’s Trichrome staining, a collagen staining). 9

44%

41.4%

40% 45%

35%

35%

31%

27,6%

25,9%

15%

14%

10%

MONTHS

3

6

9

12

15 18

3

6

9

12

15 18

24

24

IMPROVED MUCH IMPROVED VERY MUCH IMPROVED

A clinical trial by Moers-Carpi and Sherwood (2013) assessed the effectiveness of Ellansé-S (n=10) and Ellansé-M (n=30) for the correction of moderate to severe nasolabial folds using GAIS at 3, 6, 9, 12, 18 and 24 months post-treatment.

Actual patient. Individual results may vary.

8 ELLANSÉ PRACTITIONER GUIDE

9 ELLANSÉ PRACTITIONER GUIDE

Beyond Hyaluronic Acid (HA) and Collagen Stimulators

Ellansé versus Collagen Stimulators

HIGH QUALITY SCAFFOLD

SMOOTH

SPHERICAL MICROPARTICLES

IMMEDIATE AND SUSTAINED PERFORMANCE • Collagen stimulation induces long-term volumising capacity, for lasting, natural-looking results from a minimum of 18 months to 24 months.* • Immediate results compared to Poly-L-Lactic Acid (PLLA)-based filler. • Improved stability and duration compared to Calcium Hydroxylapatite (CaHA)-based filler.

Ellansé versus Hyaluronic Acid Fillers

Light microscopy: Histology 2-weeks post-injection

Light microscopy picture

Scanning Electron Microscope picture (SEM)

COLLAGEN STIMULATOR

POLYMER/ MINERAL ◊

Ellansé offers clear advantages over the NASHA-based dermal filler in terms of performance, durability and efficacy. A split-face clinical study by Galadari et al. (2015) evaluated the safety and efficacy of Ellansé S with the HA dermal filler, Perlane, when used to treat moderate to severe nasolabial folds (n=40). Efficacy was compared using the mean wrinkle severity rating score (WSRS).

• Statistically superior to an HA dermal filler, Ellansé outperforms non-animal stabilised hyaluronic acid (NASHA)- based dermal filler in both effectiveness and longevity. 10 • Compared to the NASHA-based dermal filler effect, results show that Ellansé achieved the optimal result with a 17% lower injection volume. 10 • Ellansé was shown to build greater structural support and volumisation, with significantly higher elasticity (G’ of 1,000 Pa) than the NASHA dermal filler. 7 • After neocollagenesis, Ellansé provides an elastic modulus almost equal to that of the dermis and is cosmetically more favourable than an HA dermal filler. 7

SIZE

SHAPE

SURFACE DURATION

Ellansé

PCL

25 - 50 µm Spherical

Smooth

From 18-24 months* 16

Generally spherical

CaHA

25 - 45 µm

Smooth

Over 12 months 17

Radiesse ®

Sculptra ®

PLLA

40 - 63 µm Irregular

Irregular

25 months** 18

SMOOTHER, MORE SPHERICAL MICROSPHERES. 11-15 Ellansé is composed of smooth, spherical

PCL particles with a diameter of 25-50μm. Since rough surfaces and irregular-shaped particles can cause adverse reactions (such as nodules and decreased collagen deposition), it’s been specifically designed for optimum compatibility with the body.

Ellansé microspheres Circularity (mean) † 0.997

Circularity (mean) † 0.994 Radiesse microspheres

Circularity (mean) † 0.682 Sculptra microspheres

Comparative clinical study of Ellansé versus NASHA for treatment of nasolabial folds 10

SUMMARY

PCL

NASHA

Mean Wrinkle Severity Rating Score (WSRS)

4.00

3.53

3.50

A

B

C

Baseline

3.55

3.05

3.00

2.87

PCL

2.54

2.50

NASHA

Smooth surface compared to PLLA-based filler.

Improved, long-term volume and control of mass loss compared to CaHA-based filler.

Longer-lasting results compared to PLLA and CaHA-based fillers with no top-up sessions required.

2.29

2.57**

2.57

2.21

2.16**

2.00

2.00*

12 months

1.88

1.50

Baseline Month 1 Month 3 Month 6 Month 9 Month 12

*P < 0.05 **P < 0.005

* Treatment effects have variable duration dependant on the variant used, practitioner injection technique, patient lifestyle and metabolic rate. ** Expected duration of action based on three sessions. † Roundness calculated by Flow Particle Image Analyser (FPIA).

10 ELLANSÉ PRACTITIONER GUIDE

11 ELLANSÉ PRACTITIONER GUIDE

Ellansé for volume restoration and rejuvenation Ellansé comes with the added benefit of improving the skin’s quality as evidenced clinically and via various quantitative parameters. 19, 20 In cases, with results being more significant and longer lasting than other available tested dermal fillers. 20 So, Ellansé not only immediately corrects lines and folds and gradually restores facial contours, it also enhances the skin’s density, firmness, tonicity and texture from within. 20

Ellansé versus Baseline 20

A clinical trial was conducted to assess the effect of Ellansé (n=24) on skin quality parameters at 3, 6, 9, 12, 18 and 24 months post-treatment in the mid-face.

Although Ellansé was injected in the subdermis, subject echographs clearly display a substantial increase in tissue density in the dermis.

Echographic analysis revealed the improvement of skin density was statistically significant at all time points in comparison with the baseline following treatment with Ellansé.

Percentage increase in skin density following Ellansé treatment

Skin echograph of subject mid-face pre and post Ellansé treatment

10 20 30 40 50 60 70

59.6*

56.1*

45.0*

41.3*

36.2*

16.0*

3m 6m 9m

12m 18m 24m

BASELINE

18 MONTHS POST

TIME POST-INJECTION

Ellansé also enhances a number of other skin biomechanical parameters; skin firmness, tonicity and smoothness were statistically significantly improved, in comparison with the baseline.

Percentage increase in skin firmness and tonicity following Ellansé treatment

Increase in skin smoothness following Ellansé treatment

40

5 10 15 20 25 30 35

Firmness Tonicity

0.5 1.0 1.5 2.0 2.5 3.0 3.5

35.1*

32.6*

3.01

2.67

2.27

2.09

1.99

15.9* 14.1* 16.8*

16.2*

14.3*

14.1*

1.37

9.2*

9.2*

6.5 2.3

3m

6m

9m TIME POST-INJECTION

12m 18m 24m

3m

6m

9m TIME POST-INJECTION

12m 18m 24m

Actual patient. Individual results may vary.

13 ELLANSÉ PRACTITIONER GUIDE

Where to use Ellansé?

Which areas can Ellansé treat?

Ellansé is indicated for subdermal (subcutaneous fat/hypodermis) injections. Experts recommend the injection modalities per region (upper, mid and lower-face) and per area. 21

A

UPPER-FACE

B

C

A. Forehead B. Temples C. Brow area

D

E

MID-FACE

D. Nose reshaping E. Cheek augmentation F. Nasolabial folds

F

DID YOU KNOW? Ellansé can also be injected into the nose and chin, offering a minimally-invasive alternative for reshaping and contouring. Ellansé’s characteristics make it easy to shape and mould, allowing treated areas to be defined more precisely and naturally.

A

B

G

LOWER-FACE

E

H

J

G. Oral commissures H. Marionette lines I. Chin definition J. Jawline

C

I

E

D

Model is not an actual patient.

A Epidermis B Dermis C Subcutaneous fat/hypodermis D Supraperiosteal layer E Ellansé

14 ELLANSÉ PRACTITIONER GUIDE

15 ELLANSÉ PRACTITIONER GUIDE

Audrea AGE 45 2 WEEKS AFTER ELLANSÉ PATIENT CASE STUDY

TREATMENT – MID-FACE

Piriform fossa Bolus 0.2 ml left and right Zygoma Retrograde fanning 1 ml left and right Cheeks Retrograde fanning 0.6 ml left and right

BEFORE ELLANSÉ

2 WEEKS AFTER ELLANSÉ

TREATMENT – LOWER-FACE

Jowl Retrograde fanning 0.3 ml left and right Nasolabial folds Retrograde fanning 0.3 ml left and right

BEFORE ELLANSÉ

• Loss of volume on the mid-face • Deep nasolabial folds • Sagging face

AFTER ELLANSÉ

• Volume replenished on cheeks • Softened nasolabial folds • Overall better facial definition

BEFORE ELLANSÉ

2 WEEKS AFTER ELLANSÉ

The procedure featured was performed by Dr. Victoria Manning in London, UK, using Ellansé M. Actual patient. Individual results may vary.

16 ELLANSÉ PRACTITIONER GUIDE

17 ELLANSÉ PRACTITIONER GUIDE

Cassie AGE 40 3 MONTHS AFTER ELLANSÉ PATIENT CASE STUDY

TREATMENT – MID-FACE

Piriform fossa Bolus 0.15 ml left and right Zygoma Retrograde fanning 0.9 ml left and right Preauricular area Retrograde fanning 0.3 ml left and right

BEFORE ELLANSÉ

2 WEEKS AFTER ELLANSÉ

3 MONTHS AFTER ELLANSÉ

TREATMENT – LOWER-FACE

Marionette lines Retrograde fanning 0.3 ml left and right Nasolabial folds Retrograde fanning 0.3 ml left and right

BEFORE ELLANSÉ

• Loss of volume on the mid and lower-face • Noticeable facial lines

AFTER ELLANSÉ

• Volume replenished on cheeks • Softened nasolabial folds and marionette lines

2 WEEKS AFTER ELLANSÉ

3 MONTHS AFTER ELLANSÉ

BEFORE ELLANSÉ

The procedure featured was performed by Dr. Victoria Manning in London, UK, using Ellansé M. Actual patient. Individual results may vary.

18 ELLANSÉ PRACTITIONER GUIDE

19 ELLANSÉ PRACTITIONER GUIDE

Micheal AGE 57 3 MONTHS AFTER ELLANSÉ PATIENT CASE STUDY

TREATMENT – MID-FACE

Piriform fossa Bolus 0.15 ml left and right Cheeks Retrograde fanning 0.7 ml left and right

BEFORE ELLANSÉ

2 WEEKS AFTER ELLANSÉ

3 MONTHS AFTER ELLANSÉ

TREATMENT – LOWER-FACE

Marionette lines Retrograde fanning 0.8 ml left and right Jawline Retrograde fanning 0.8 ml left and right

BEFORE ELLANSÉ

• Loss of volume on the mid-face • Noticeable facial lines • Uncontoured jawline

AFTER ELLANSÉ

• Volume replenished on cheeks • Softened marionette lines • Redefined chin

BEFORE ELLANSÉ

2 WEEKS AFTER ELLANSÉ

3 MONTHS AFTER ELLANSÉ

The procedure featured was performed by Dr. Victoria Manning in London, UK, using Ellansé M. Actual patient. Individual results may vary.

20 ELLANSÉ PRACTITIONER GUIDE

21 ELLANSÉ PRACTITIONER GUIDE

Paul AGE 48 3 MONTHS AFTER ELLANSÉ PATIENT CASE STUDY

TREATMENT – MID-FACE

Cheeks Retrograde fanning 0.4 ml left and right

TREATMENT – LOWER-FACE

BEFORE ELLANSÉ

2 WEEKS AFTER ELLANSÉ

3 MONTHS AFTER ELLANSÉ

Mandibular angle Bolus 0.2 ml left and right Jawline Retrograde fanning 0.8 ml left and right Mental crease Retrograde fanning 1.2 ml Chin Bolus 1.2 ml

BEFORE ELLANSÉ

• Loss of volume on the mid and lower-face • Undefined and uncontoured jawline • Receding chin

AFTER ELLANSÉ

• Volume replenished on cheeks • Jawline definition recreated • Chin projection created

BEFORE ELLANSÉ

2 WEEKS AFTER ELLANSÉ

3 MONTHS AFTER ELLANSÉ

The procedure featured was performed by Dr. Victoria Manning in London, UK, using Ellansé M. Actual patient. Individual results may vary.

22 ELLANSÉ PRACTITIONER GUIDE

23 ELLANSÉ PRACTITIONER GUIDE

High patient satisfaction 6

Patient satisfaction rated at 24 months following treatment with Ellansé S and Ellansé M.

72% ELLANSÉ S

82% ELLANSÉ M

Mean patient satisfaction using Visual Analogue Scale (VAS).

75% ELLANSÉ S

78% ELLANSÉ M

Patient willingness to repeat treatment at 24 months post-injection.

A year after Ellansé it felt fantastic to be told by friends that I looked much younger than my true age.

Model is not an actual patient.

PATIENT TESTIMONIES

MARIA 12 MONTHS AFTER ELLANSÉ

24 ELLANSÉ PRACTITIONER GUIDE

25 ELLANSÉ PRACTITIONER GUIDE

Ellansé by Sinclair. Transforming customer confidence.

Ellansé is part of Sinclair's global portfolio. Founded in 1977, Sinclair delivers a unique range of scientifically-advanced, high-margin aesthetic products and services made exclusively for a worldwide industry of high-skilled clinicians.

But beautiful, lasting results aren’t down to products alone. It’s the combination of science and talent that creates the kind of transformations that can change lives for the better. It’s this understanding that makes Sinclair's approach to high standards unwavering. That’s why we place as much emphasis on supporting our exceptional clinicians through training, as we do on our product portfolio.

WITH ELLANSÉ YOU’LL HAVE ACCESS TO:

Sinclair College Sinclair's educational arm, providing quality training and education, through collaboration and insight from worldwide experts. Unlock specialist Ellansé training from the Sinclair College platform; available on desktop and via My E-College App.

Ongoing practice support A dedicated Sales Representative, as well as free marketing materials via the Sinclair Portal. A free platform from where you can download our product brochures, aftercare leaflets and waiting room videos. Ellansé Expert's Guide A book presenting a novel approach to the art of injecting, detailing all you need to know about Ellansé. From the latest detail on facial anatomy and the ageing process to best practice guidance from leading physicians and a discussion on the latest technologies to deliver Augmented Reality assets that bring the Ellansé injection techniques to life.

Not a member yet? Scan the QR code using a mobile device.

Models are not actual patients.

26 ELLANSÉ PRACTITIONER GUIDE

27 ELLANSÉ PRACTITIONER GUIDE

Ellansé publication listing

PCL-based dermal fillers offer advantages over the NASHA-based dermal fillers, in terms of both cosmetic longevity and efficiency. 17% less injection volume was required with Ellansé to reach optimal cosmetic effects compared to the NASHA dermal filler. Galadari H, et al. A randomised, prospective, blinded, split-face, single-centre study comparing polycaprolactone to hyaluronic acid for treatment of nasolabial folds. J Cosmet Dermatol. 2015;14(1):27-32. 13 months after an Ellansé-M injection, PCL microspheres were surrounded by collagen deposition and a mild fibroblastic and histiocytic tissue response was seen. This confirms that PCL particles are maintained in their original state at least 13 months post-injection in human tissue.

A novel dermal filler and promising new device with immediate aesthetic correction and sustained results due to the formation of new collagen. The PCL microspheres in the filler trigger a natural response within the human body to stimulate neocollagenesis.

Gritzalas K. Preliminary results in using a new dermal filler based on poly-caprolactone. Eur J Aesth Med Dermatol. 2011;1:22-26.

Mixing lidocaine into the PCL-based dermal filler can be safely performed without causing harmful changes to the physical properties of the original dermal filler. Adding up to 0.3% of the anaesthetic agent lidocaine will not substantially affect the filler’s characteristics, confirming the usability of this mixture in clinical practice. De Melo F, Marijnissen-Hofsté J. Investigation of physical properties of a polycaprolactone dermal filler when mixed with lidocaine and lidocaine/ epinephrine. Dermatol Ther. 2012;2:13-22. Ellansé is safe, well tolerated and effective for hand rejuvenation with high patient satisfaction and retention rates. Ellansé provides an immediate effect and offers a good choice based on its longevity.

Kim JA, Van Abel D. Neocollagenesis in human tissue injected with a polycaprolactone-based dermal filler. J Cosmet Laser Ther. 2015;17(2):99-101.

Ellansé shows advantages over an HA dermal filler when applied to the forehead. Ellansé has significantly higher elasticity (G’) compared to the HA dermal filler and the non-crosslinked CMC molecules make it smoother and easier to inject. These neocollagenesis benefits are long term and the natural looking results last for at least 24 months.

Figueiredo VM. A five-patient prospective pilot study of a polycaprolactone based dermal filler for hand rejuvenation. J Cosmet Dermatol. 2013;12:73-77.

Bae B, et al. Safety and long-term efficacy of forehead contouring with a polycaprolactone-based dermal filler. Dermatol Surg. 2016;42(11):1256-60.

Ellansé-S and Ellansé-M are safe and have sustained efficacy and high patient satisfaction results over 24 months. Ellansé is a unique option for patients seeking longer lasting but non-permanent results. Moers-Carpi MM, Sherwood S. Polycaprolactone for the correction of nasolabial folds: a 24-month, prospective, randomized, controlled clinical trial. Dermatol Surg. 2013;39 (3 Pt 1):457-63. The PCL microspheres of Ellansé-M are still present 21 months post-injection. The PCL microspheres are embedded in a collagen scaffold of primarily type-1 collagen fibres.

A multinational, multidisciplinary group of experts, plastic surgeons and dermatologists have developed recommendations on the injection techniques of Ellansé. These recommendations provide a guideline for physicians who wish to perform safe and efficacious treatment for volume augmentation and rejuvenation of the face and hands. De Melo F et al. Recommendations for volume augmentation and rejuvenation of the face and hands with the new generation polycaprolactone-based collagen stimulator (Ellansé®). Clinical, Cosmetic and Investigational Dermatology 2017:10 431-440. A 46-year-old Asian woman was treated with Ellansé to restore facial volume loss. Facial images after Ellansé treatment revealed a more reverse triangular shaped and in proportion rejuvenated face coupled with the improvement of a downward shift of soft tissue

Nicolau P, Marijnissen-Hofsté J. Neocollagenesis after injection of a polycaprolactone based dermal filler in a rabbit. Eur.J.Aesth Medicine and Dermatology. 2013;3:19-26.

Lin SL. Polycaprolactone facial volume restoration of a 46-year-old Asian woman: A case report. J Cosmet Dermatol. 2018; 1-5.

Model is not an actual patient.

28 ELLANSÉ PRACTITIONER GUIDE

29 ELLANSÉ PRACTITIONER GUIDE

References

1. Data on file. 2. Whitepaper W113.05.

13. Anderson JM. Mechanism of inflammation and infection with implanted devices. Cardiovasc Pathol. 1993;2:33S-41S. 14. Matlage BF et al. Tissue response to implanted polymers: The significance of sample shape. J Biomed Meter Res. 1976;10:391-397. 15.Nicolau PJ. Long-Lasting and permanent fillers: Biomaterials influence over host response. Plast Reconstr Surg. 2007; 119:2271-2286. 16. Ellansé Instruction for Use. Sinclair IS Pharma Corporate. 2016. 17. Radiesse instruction for Use. Merz Aesthetics. 2016. 18. Sculptra Instruction for Use. Galderma. 2016. 19. Moers-Carpi MM, Christen MO, Delmar H, Brun P, Bodokh I, Kestemont P. European Multicenter prospective clinical study evaluating long-term safety and efficacy of the polycaprolactone –based dermal filler in nasolabial fold correction. Dermatol Surg 2021, Accepted. 20. Converset-Viethel S. A prospective, randomized, controlled, comparative, single-centre study on the safety and effectiveness of Ellansé® dermal filler for correction of age-related volume deficit in the mid-face. Internal report 2020. 21. Francisco de Melo F, Nicolau P, Piovano L, Lin SL, Baptista-Fernandes T, Martyn I King M, Camporese A, Hong K, Khattar MM, Christen MO. Recommendations for volume augmentation and rejuvenation of the face and hands with the new generation polycaprolactone-based collagen stimulator (Ellansé®). Clinical, Cosmetic and Investigational Dermatology 2017:10 431-440.

3. Christen MO, Vercesi.F. Polycaprolactone: Or How a Well-Known and Futuristic Polymer Has Become an Innovative Collagen-Stimulator in Aesthetics. Clin

Cosmet and Investig Dermatol 2020; 12:1-18. 4. Ellansé post market surveillance report, 2022. 5. Christen MO Ellansé safety report. 2016.

6. Moers-Carpi MM, Sherwood S. Polycaprolactone for the correction of nasolabial folds: a 24-month, prospective, randomized, controlled clinical trial. Dermatol Surg. 2013;39 (3 Pt 1):457-63. 7. Bae B, et al. Safety and long-term efficacy of forehead contouring with a polycaprolactone-based dermal filler. Dermatol Surg. 2016;42(11):1256-60. 8. Nicolau P, Marijnissen-Hofsté J. Neocollagenesis after injection of a polycaprolactone based dermal filler in a rabbit. Eur.J.Aesth Medicine and Dermatology. 2013;3:19-26. 9. Kim JA, Van Abel D. Neocollagenesis in human tissue injected with a polycaprolactone-based dermal filler. J Cosmet Laser Ther. 2015;17(2):99-101. 10. Galadari H, et al. A randomised, prospective, blinded, split-face, single-centre study comparing polycaprolactone to hyaluronic acid for treatment of nasolabial folds. J Cosmet Dermatol. 2015;14(1): 27-32. 11. Laeschke K. Biocompatibility of microparticles into soft tissue fillers. Semin Cutan Med Surg. 2004; 23(4):214-217. 12. Morhenn VB et al. Phagocytosis of different particulate dermal filler substances by human macrophages and skin cells. Dermatol Surg. 2002;28(6):484-490.

30 ELLANSÉ PRACTITIONER GUIDE

1st Floor Whitfield Court, 30-32 Whitfield St, London, W1T 2RQ, United Kingdom. E. ellanse@sinclair.com www.ellanse.com

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