At Sinclair, we offer a unique range of Scientifically-advanced aesthetic products and services made for skilled clinicians; ensuring long-lasting and exceptional results.
MaiLi Lanluma Ellansé
Tailoring treatment with the right product to provide individualised outcomes
MaiLi
Lanluma Ellansé
PRODUCT COMPARISON
PRODUCT COMPARISON MaiLi, Lanluma and Ellansé
MaiLi
Lanluma
Ellansé
Product
Delayed volumising bio-stimulator
Immediate volumising bio-stimulator
Category
Hyaluronic Acid (HA) filler
Volumisation, projection, contouring, enhancement and wrinkle correction with natural-looking results
Volumisation, stimulation of type 1 collagen, and skin quality improvement
Improves skin tightness and texture
Benefits
Hyaluronic Acid (HA), pre-filled syringe ready to use
Poly-L-Lactic Acid (PLLA), vials with PLLA powder. To be reconstituted
Polycaprolactone (PCL) and Carboxymethyl Cellulose (CMC), pre-filled syringe ready to use
Main ingredient and presentation
Ellansé S: duration up to 18 months 1 Ellansé M: duration up to 24 months 1
duration of at least 12 months 1
1-3 sessions, duration up to 24 months 1
Duration
Indicated areas
Face
Face and body
Face
1. Sinclair Pharma. Data on file. Treatment effects have variable duration dependant on the variant used, practitioner injection technique, patient lifestyle and metabolic rate.
MaiLi
Lanluma Ellansé
PRODUCT COMPARISON
MaiLi is a next-generation hyaluronic acid range featuring award-winning Oxifree ™ technology, delivering the desired projection with less product, enabling HCPs to deliver natural-looking patient results.
Features Before & After Results 1 2 3 Why MaiLi
MaiLi
Lanluma Ellansé
PRODUCT COMPARISON
1
Who is MaiLi for?
Patients and practitioners who want:
Reduced signs of ageing 1
Natural- and youthful-looking
Long-lasting results with no need for top-ups 2
Fast acting volume restoration 3
Optimal product biocompatibility
1. Sinclair Pharma. MaiLi Physician Leaflet. 2021; 2. Sinclair Pharma. Data on file; 3. Sinclair Pharma. MaiLi Instructions for Use.
Features Before & After Results 1 2 3 Why MaiLi
Who is MaiLi for?
MaiLi Range
Published Evidence
Product Summary
Mode of Action
MaiLi
Lanluma Ellansé
PRODUCT COMPARISON
2
FEATURE 1
Why choose MaiLi?
Advanced OxiFree ™ technology removes reactive oxygen from MaiLi, protecting the product from degradation and offering long-lasting effects of at least 12 months. This technology uses low amounts of the cross-linking agent BDDE .
1
Award-winning OxiFree ™ technology
Sinclair Pharma. MaiLi Physician Leaflet. 2021.
Features Before & After Results 1 2 3 Why MaiLi
Who is MaiLi for?
MaiLi Range
Published Evidence
Product Summary
Mode of Action
MaiLi
Lanluma Ellansé
PRODUCT COMPARISON
3
FEATURE 1
Award-Winning Technology
Sustained high performance results and suppleness with no touch-ups % improvement in GAIS score across MaiLi range
OxiFree ™ is an advanced crosslinking technology
120 %
100 %
• Reduced chemical crosslinking
95 %
100 %
93 %
81 %
80 %
• Reactive oxygen removal protects HA network from degradation • Supple, long-lasting volumising effects (at least 12 months * , including in lips)
60 %
40 %
n=110
n=110
n=110
n=110
20 %
0 %
After injection
M 1
M6
M 12
of treated indications were improved , very improved or exceptionally improved at 81% 12 months with no top-up treatment… …with exceptional longevity in lip treatments up to a year
*Treatment effects have variable duration dependent on the variant used, practitioner injection technique, patient lifestyle and metabolic rate.
Features Before & After Results 1 2 3 Why MaiLi
Sinclair Pharma. Data on file: Clinical investigation 17E1176.
Who is MaiLi for?
MaiLi Range
Published Evidence
Product Summary
Mode of Action
MaiLi
Lanluma Ellansé
PRODUCT COMPARISON
4
FEATURE 1
Award-Winning Technology
OxiFree ™ Technology – Winner of the "Pioneering and Innovation" award
Features Before & After Results 1 2 3 Why MaiLi
Who is MaiLi for?
MaiLi Range
Published Evidence
Product Summary
Mode of Action
MaiLi
Lanluma Ellansé
PRODUCT COMPARISON
5
FEATURE 2
Why choose MaiLi?
2
Excellent projection with less product *
MaiLi requires 24% less * product than reference HA to achieve desired patient results. This can allow the treatment of more facial areas for optimal full-face enhancement.
* Sinclair Pharma. Data on file. Reference HA filler. Juvéderm Voluma.
Features Before & After Results 1 2 3 Why MaiLi 2
Who is MaiLi for?
MaiLi Range
Published Evidence
Product Summary
Mode of Action
MaiLi
Lanluma Ellansé
PRODUCT COMPARISON
6
FEATURE 2
Same projection with less product
Injected quantity (ml) required to achieve the same volume results
0 . 0 0 . 2 0 . 4 0 . 6 0 . 8 1 . 0 1 . 2 1 . 4 1 . 6 1 . 8
24% less * product is needed to produce the same volume compared with competitor.
1 . 39
1 . 12
MaiLi Extreme
Juvéderm Voluma
Sinclair Pharma. Data on file: Clinical investigation 17E1176
* Sinclair Pharma. Data on file. Reference HA filler. Juvéderm Voluma.
Features Before & After Results 1 2 3 Why MaiLi 2
Who is MaiLi for?
MaiLi Range
Published Evidence
Product Summary
Mode of Action
MaiLi
Lanluma Ellansé
PRODUCT COMPARISON
7
FEATURE 3
Why choose MaiLi?
A combination of projection power and supreme suppleness helps injectors achieve natural looking results. 1,2 MaiLi’s unique Smart Spring Science – with spring-like qualities – works in harmony with natural facial movement and expression. 1,2
3
Natural-looking patient results
1. De Melo F , et al. Clin Cosmet Investig Dermatol . 2020;13:333–44; 2. Sinclair Pharma. MaiLi physician leaflet. 2021.
Features Before & After Results 1 2 3 Why MaiLi 3
Who is MaiLi for?
MaiLi Range
Published Evidence
Product Summary
Mode of Action
MaiLi
Lanluma Ellansé
PRODUCT COMPARISON
8
FEATURE 3
Natural-looking patient results
Flexible. Volumising. Dynamic.
G’ (Elastic Modulus): Gives information about texture, gel stiffness High G’ (600 – 800 Pa): Very Stiff Low G’ (80 – 150 Pa): Very Soft Fn (Normal Force): Cohesivity and projection capacity
High Cohesivity / Projection: Used for volume & creating shadows (Jawlines…)
Low Cohesivity / Projection: Used for better tissue integration, sensitive areas (Lips)
Typically, as (HA) gels increase their projection capacity, there is a corre- sponding increase in their G' value 1,2
High Fn
Tissues
More projection
Low Fn
Tissues
More Spreading
1. de la Guardia C, et al. Facial Plast Surg 2022;38:116–123; 2 Sinclair Pharma. MaiLi physician leaflet. 2021.
Features Before & After Results 1 2 3 Why MaiLi 3
Who is MaiLi for?
MaiLi Range
Published Evidence
Product Summary
Mode of Action
MaiLi
Lanluma Ellansé
PRODUCT COMPARISON
9
FEATURE 3
Natural-looking patient results
MaiLi delivers high projection while maintaining suppleness 1,2
G’ (Pa) 1
Fn (gmf) 1
High projection capacity
MaiLi Extreme
MaiLi Precise
140
29
MaiLi Define
200
47
MaiLi Volume
MaiLi Volume
260
99
Juvéderm Volux
MaiLi Extreme
320
158
MaiLi De fi ne
Juvederm Volbella
271
19
Juvéderm Voli ft
MaiLi Precise
Juvéderm Voluma
Juvederm Volift
340
30
Low projection capacity
Juvederm Voluma
398
40
Juvéderm Volbella
Juvederm Volux
665
93
Suppleness
F i rmness
Elastic Modulus (G’)
Sinclair Pharma. Data on file.
1. Sinclair France SAS. Data on file; 2. HA Filler Characteristics Review de la Guardia et al., Facial Plast Surg 2022;38:116–123.
Features Before & After Results 1 2 3 Why MaiLi 3
Who is MaiLi for?
MaiLi Range
Published Evidence
Product Summary
Mode of Action
MaiLi
Lanluma Ellansé
PRODUCT COMPARISON
10
FEATURE 3
Natural-looking patient results
Smart Spring Science
Spring-like behaviour thanks to the combination of a relatively low G' (allowing mouldability) with a relatively high F N (providing projection capacity)
A uniquely supple gel that responds exceptionally well to pressure.
Follows the natural movements of the face Returns to its initial shape Recovers following vertical stress Resists external impacts
Features Before & After Results 1 2 3 Why MaiLi 3
Who is MaiLi for?
MaiLi Range
Published Evidence
Product Summary
Mode of Action
MaiLi
Lanluma Ellansé
PRODUCT COMPARISON
11
FEATURE 3
Natural-looking patient results
Photo courtesy of Dr. Jorge Mercado, Spain. Actual patients, results may vary . 2 hours after treatment. Treatment details for each side: Zygomatic 0.2ml – MaiLi Extreme Lateral SOOF 0.1ml – MaiLi Extreme Medial SOOF 0.2ml – MaiLi Extreme Malar 0.1ml – MaiLi Extreme
Features Before & After Results 1 2 3 Why MaiLi 3
Piriform fossa 0.3ml – MaiLi Extreme Chin 0.6ml – MaiLi Extreme Lip 0.30ml – MaiLi Precise Labiomental groove 0.35ml – MaiLi Volume Superior supraorbicular oral 0.15ml – MaiLi Volume
Who is MaiLi for?
MaiLi Range
Published Evidence
Product Summary
Mode of Action
MaiLi
Lanluma Ellansé
PRODUCT COMPARISON
12
The MaiLi range 1,2
Each product has a different concentration and provides its own benefits
One range | Four products | Endless possibilities. MaiLi Precise A long lasting solution to fine lines and tear trough * MaiLi Define For deep wrinkles and lip restructuring
MaiLi Volume A multi-purpose facial volumiser
MaiLi Extreme Our most powerful tool for facial shaping and sculpture
* The application of MaiLi Precise in the periorbital area is reserved to specialists specifically trained in this technique and having sound knowledge of the anatomy and physiology for this area.
Actual patients, results may vary.
MaiLi's safety rate is 99.98% 2
Features Before & After Results 1 2 3 Why MaiLi
1. Sinclair Pharma. MaiLi Phyician leaflet; 2. Sinclair Pharma, Data on file. MaiLi Safety Profile (December 2022-November 2024).
Who is MaiLi for?
MaiLi Range
Published Evidence
Product Summary
Mode of Action
MaiLi
Lanluma Ellansé
PRODUCT COMPARISON
13
The MaiLi range 1,2
Each product has a different concentration and provides its own benefits
One range | Four products | Endless possibilities. MaiLi Precise A long lasting solution to fine lines and tear trough * MaiLi Define For deep wrinkles and lip restructuring
MaiLi Volume A multi-purpose facial volumiser
MaiLi Extreme Our most powerful tool for facial shaping and sculpture
* The application of MaiLi Precise in the periorbital area is reserved to specialists specifically trained in this technique and having sound knowledge of the anatomy and physiology for this area.
Actual patients, results may vary.
MaiLi's safety rate is 99.98% 2
Features Before & After Results 1 2 3 Why MaiLi
1. Sinclair Pharma. MaiLi Phyician leaflet; 2. Sinclair Pharma, Data on file. MaiLi Safety Profile (December 2022-November 2024).
Who is MaiLi for?
MaiLi Range
Published Evidence
Product Summary
Mode of Action
MaiLi
Lanluma Ellansé
PRODUCT COMPARISON
13
The MaiLi range 1,2
Each product has a different concentration and provides its own benefits
One range | Four products | Endless possibilities. MaiLi Precise A long lasting solution to fine lines and tear trough * MaiLi Define For deep wrinkles and lip restructuring
MaiLi Volume A multi-purpose facial volumiser
MaiLi Extreme Our most powerful tool for facial shaping and sculpture
* The application of MaiLi Precise in the periorbital area is reserved to specialists specifically trained in this technique and having sound knowledge of the anatomy and physiology for this area.
Actual patients, results may vary.
MaiLi's safety rate is 99.98% 2
Features Before & After Results 1 2 3 Why MaiLi
1. Sinclair Pharma. MaiLi Phyician leaflet; 2. Sinclair Pharma, Data on file. MaiLi Safety Profile (December 2022-November 2024).
Who is MaiLi for?
MaiLi Range
Published Evidence
Product Summary
Mode of Action
MaiLi
Lanluma Ellansé
PRODUCT COMPARISON
13
The MaiLi range 1,2
Each product has a different concentration and provides its own benefits
One range | Four products | Endless possibilities. MaiLi Precise A long lasting solution to fine lines and tear trough * MaiLi Define For deep wrinkles and lip restructuring
MaiLi Volume A multi-purpose facial volumiser
MaiLi Extreme Our most powerful tool for facial shaping and sculpture
* The application of MaiLi Precise in the periorbital area is reserved to specialists specifically trained in this technique and having sound knowledge of the anatomy and physiology for this area.
Actual patients, results may vary.
MaiLi's safety rate is 99.98% 2
Features Before & After Results 1 2 3 Why MaiLi
1. Sinclair Pharma. MaiLi Phyician leaflet; 2. Sinclair Pharma, Data on file. MaiLi Safety Profile (December 2022-November 2024).
Who is MaiLi for?
MaiLi Range
Published Evidence
Product Summary
Mode of Action
MaiLi
Lanluma Ellansé
PRODUCT COMPARISON
13
The MaiLi range 1,2
Each product has a different concentration and provides its own benefits
One range | Four products | Endless possibilities. MaiLi Precise A long lasting solution to fine lines and tear trough * MaiLi Define For deep wrinkles and lip restructuring
MaiLi Volume A multi-purpose facial volumiser
MaiLi Extreme Our most powerful tool for facial shaping and sculpture
* The application of MaiLi Precise in the periorbital area is reserved to specialists specifically trained in this technique and having sound knowledge of the anatomy and physiology for this area.
Actual patients, results may vary.
MaiLi's safety rate is 99.98% 2
Features Before & After Results 1 2 3 Why MaiLi
1. Sinclair Pharma. MaiLi Phyician leaflet; 2. Sinclair Pharma, Data on file. MaiLi Safety Profile (December 2022-November 2024).
Who is MaiLi for?
MaiLi Range
Published Evidence
Product Summary
Mode of Action
MaiLi
Lanluma Ellansé
PRODUCT COMPARISON
13
Before & After SEE THE DIFFERENCE
BEFORE
IMMEDIATLEY AFTER
Photo Courtesy of Dr. Sonja Đorđević, Serbia. Actual patient, individual results may vary. Zygomatic region 1ml – MaiLi Extreme Malar region 1.5ml – MaiLi Volume Malar region in SOOF 0.5ml – MaiLi Define Nasolabial folds 0.5ml – MaiLi Define Lips 1ml – MaiLi define
Features Before & After Results 1 2 3 Why MaiLi
Who is MaiLi for?
MaiLi Range
Published Evidence
Product Summary
Mode of Action
MaiLi
Lanluma Ellansé
PRODUCT COMPARISON
14
Before & After SEE THE DIFFERENCE
BEFORE
IMMEDIATLEY AFTER
Photo Courtesy of Dr. Iva Ćirović, Serbia. Actual patient, individual results may vary. Cheekbones 2ml – MaiLi Volume Lips 0.5ml – MaiLi Define Chin and jawline 3 ml – MaiLi Extreme
Features Before & After Results 1 2 3 Why MaiLi
Who is MaiLi for?
MaiLi Range
Published Evidence
Product Summary
Mode of Action
MaiLi
Lanluma Ellansé
PRODUCT COMPARISON
14
Published evidence for MaiLi
This article evaluates the relevance of the key rheological parameters during the main steps of the clinical HA fillers’ lifetime.
Plastic and Aesthetic Research
Gavard Molliard et al . Plast Aesthet Res 2018;5:17 DOI: 10.20517/2347-9264.2018.10
Open Access
Original Article
Key rheological properties of hyaluronic acid fillers: from tissue integration to product degradation Samuel Gavard Molliard 1 , Jérémie Bon Bétemps 1 , Basste Hadjab 1 , David Topchian 2 , Patrick Micheels 3 , Denis Salomon 4 1 Research and Development Department, Kylane Laboratoires S.A., Plan-les-Ouates 1228, Switzerland. 2 Dr. David & Associates Private Practice, Armadale VIC 3143, Australia. 3 Dr. Patrick Micheels Private Practice, Genève 1206, Switzerland. 4 Clinique Internationale de Dermatologie Genève S.A. Private Practice, Genève 1201, Switzerland.
Mollard Gavard S, et al. Plast Aesthet Res 2018;5:17
Correspondence to : Dr. Samuel Gavard Molliard, Research and Development Department, Kylane Laboratoires S.A., Chemin des Aulx 14, Plan-les-Ouates 1228, Switzerland. E-mail: samuel.gavard@yahoo.fr
How to cite this article : Gavard Molliard S, Bon Bétemps J, Hadjab B, Topchian D, Micheels P, Salomon D. Key rheological properties of hyaluronic acid fillers: from tissue integration to product degradation. Plast Aesthet Res 2018;5:17. http://dx.doi.org/10.20517/2347-9264.2018.10
Received : 24 Feb 2018 First Decision : 29 Mar 2018 Revised : 3 Apr 2018 Accepted : 4 Apr 2018 Published : 14 May 2018
Science Editor : Wen-Guo Cui Copy Editor : Guang-Zhe Zhu Production Editor : Cai-Hong Wang
Abstract Aim : Over the last 15 years, hyaluronic acid (HA) fillers have become the most popular injectable biomaterial for soft tissue correction. With the increasing number of available HA fillers and the multiplication of facial treatments all over the world, there has been a need from physicians to better understand the HA fillers science. There is especially a growing interest in the science-based evaluation of rheological characteristics which represents an essential tool to guide physicians in the selection of the most appropriate HA fillers, administration techniques and depths of injection for their clinical applications.
Methods : Four key rheological parameters (viscosity η , elasticity G’, normal force F N and elasticity E’) are measured and discussed on five HA fillers.
Results : These four key rheological parameters are demonstrated to play a pivotal role, in combination with the cohesivity, for better predicting the clinical behavior of HA fillers at different stages of their lifetime.
Conclusion : This article discusses the importance of four key rheological parameters during the main steps of the clinical HA fillers’ lifetime, from the product injection to the loss of clinical effects. A better knowledge of these HA fillers’ rheological parameters can help the physicians to optimize their aesthetic outcomes, safety and patient satisfaction.
Keywords : Hyaluronic acid fillers, rheological properties, product lifetime, tissue integration, clinical effects
© The Author(s) 2018. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, sharing, adaptation, distribution and reproduction in any medium or format, for any purpose, even commercially, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
www.parjournal.net
Features Before & After Results 1 2 3 Why MaiLi
Who is MaiLi for?
MaiLi Range
Published Evidence
Product Summary
Mode of Action
MaiLi
Lanluma Ellansé
PRODUCT COMPARISON
15
Published evidence for MaiLi
This article highlights the use of a new skin model assay to assess the projection capacity of an OxiFree ™ manufactured filler and a VYCROSS (propriety technology) manufactured filler.
Plastic and Aesthetic Research
Bon Betemps et al . Plast Aesthet Res 2018;5:19 DOI: 10.20517/2347-9264.2018.24
Open Access
Original Article
Projection capacity assessment of hyaluronic acid fillers Jérémie Bon Betemps 1 , Francesco Marchetti 2 , Tingsong Lim 3 , Basste Hadjab 1 , Patrick Micheels 4 , Denis Salomon 5 , Samuel Gavard Molliard 1 1 Research and Development Department, Kylane Laboratoires S.A., Plan-les-Ouates 1228, Switzerland. 2 Surgeon Roma Plastic Surgery Center Private Practice, Roma 00199, Italy. 3 Clique Clinic Private Practice, Petaling Jaya 46300, Malaysia. 4 Dr. Patrick Micheels Private Practice, Genève 1206, Switzerland. 5 Clinique Internationale de Dermatologie Genève S.A. Private Practice, Genève 1201, Switzerland.
Correspondence to : Dr. Samuel Gavard Molliard, Research and Development Department, Kylane Laboratoires S.A., Plan-les- Ouates 1228, Switzerland. E-mail: samuel.gavard@yahoo.fr
How to cite this article : Bon Betemps J, Marchetti F, Lim T, Hadjab B, Micheels P, Salomon D, Gavard Molliard S. Projection capacity assessment of hyaluronic acid fillers. Plast Aesthet Res 2018;5:19. http://dx.doi.org/10.20517/2347-9264.2018.24
Bon Betemps J, et al. Plast Aesthet Res 2018;5:19
Received : 17 Apr 2018 First Decision : 18 May 2018 Revised : 11 Jun 2018 Accepted : 11 Jun 2018 Published : 28 Jun 2018
Science Editor : Raúl González-García Copy Editor : Jun-Yao Li Production Editor : Cai-Hong Wang
Abstract Aim : Hyaluronic acid (HA) is considered as the gold standard biomaterial for facial soft tissue correction. Over the last 8 years, there has been a strong demand from physicians for HA products with high projection capacity to restore facial volume loss at the level of the cheeks, cheekbones, chin, temples and jawlines. The projection capacity is thus an essential property for HA fillers especially for the products dedicated to the restoration of the volume of the face.
Methods : In this publication, a new skin model assay for evaluating the projection capacity of HA fillers is presented, applied and discussed.
Results : This skin model assay enables to efficiently assess the projection capacity of a HA filler product. The comparative evaluation of a product benefiting from the novel OXIFREE technology and Juvéderm Voluma shows a higher projection capacity for the OXIFREE product than for Juvéderm Voluma.
Conclusion : This assay is demonstrated to be a key tool to guide physicians in the selection of products with high ability of tissue projection to optimize their aesthetic outcomes when they need to create facial volume.
Keywords : Hyaluronic acid fillers, projection capacity, skin model assay, facial volume
© The Author(s) 2018. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, sharing, adaptation, distribution and reproduction in any medium or format, for any purpose, even commercially, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
www.parjournal.net
Features Before & After Results 1 2 3 Why MaiLi
Who is MaiLi for?
MaiLi Range
Published Evidence
Product Summary
Mode of Action
MaiLi
Lanluma Ellansé
PRODUCT COMPARISON
15
Published evidence for MaiLi
Journal of Clinical and Cosmetic Dermatology ISSN 2576-2826 | Open Access
Sci Forschen Open HUB for Scientific Research
This article present preliminary safety and efficacy data from the first private patient series treated with the first patented OxiFree ™ technology cross-linked hyaluronic acid gel – MaiLi.
RESEARCH ARTICLE A Preliminary Report on the Safety and Efficacy of a Novel MaiLi HA Filler for Facial Correction of Wrinkles, Folds, Volume and Lips Patrick Micheels 1, *, and Mickaël Poiraud 2 Volume 7 - Issue 1
1 Private office, Chemin de la Fontaine, Chêne-Bougeries, Switzerland 2 Clinique de la Croix d’Or, ASLAN Medical SA, Geneva, Switzerland
*Corresponding author: Patrick Micheels, Private office, Chemin de la Fontaine, Chêne-Bougeries, Switzerland, Tel: +41(0)223471113; E-mail: patrickscab@bluewin.ch
Received: 13 Dec, 2022 | Accepted: 12 Jan, 2023 | Published: 18 Jan, 2023
Citation: Micheels P, Poiraud M (2023) A Preliminary Report on the Safety and Efficacy of a Novel MaiLi HA Filler for Facial Correction of Wrinkles, Folds, Volume and Lips. J Clin Cosmet Dermatol 7(1): dx.doi.org/10.16966/2576-2826.175 Copyright: © 2023 Micheels P, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Abstract Introduction: The principal author was given the opportunity to assess new hyaluronic acid filler, first before its European Commission labeling during clinical investigations in France, and then after its European Commission labeling in his clinical practice in Geneva, Switzerland. This hyaluronic acid gel benefits from the world’s first patented OxiFree™ technology. This article sought to present preliminary safety and efficacy data from the first private patient series treated in Geneva with this cross-linked hyaluronic acid gel, called MaiLi. Material and methods: Like most of its competitors, MaiLi is available in various variants, including gel for filling fine wrinkles, for deeper wrinkles, folds, and for lip enhancement, in addition to gels for volumizing indications. This cohort study encompassed patients from the authors’ private esthetic clientele in Geneva, Switzerland. Depending on the indications, the injections were performed according to previously described techniques, ranging from the “blanching technique” to deeper injections. Results: Between January and November 2021, overall 45 patients aged 56 years on average were injected MaiLi gels, according to the areas they wished to be treated, with a follow-up period ranging from a few days to 12 months. Based on our current dataset, we confirm that MaiLi fillers have proven very safe, causing no unexpected undesirable effects. The gel’s hold over time related to its remarkable projection capacity was excellent, resulting in quite natural outcomes and a perfect integration into the tissues. These beneficial effects were still evident at 1-year follow-up. Conclusion: The MaiLi hyaluronic acid fillers proved to be well tolerated and safe, with long-lasting effects. Remarkable properties revealed in this follow-up were their projection capacity and suppleness, as well as their ease of use and longevity, resulting in full patient satisfaction. No relevant undesirable effects were observed. There were no edematous reactions following the injections, nor were there any lymphatic circulation disorders. Keywords: Hyaluronic acid; Volumizer gels; Skin rejuvenation; OxyFree technology
Micheels P and Poiraud M. J Clin Cosmet Dermatol 2023;7(1):1–8
Introduction The first injectable wrinkle fillers date back to 1980-1981, when bovine collagen was employed, following their approval by the American Food and Drug Administration as cosmetic drugs [1]. Given that natural Hyaluronic Acid (HA) undergoes extremely rapid turn-over within the skin, commercially available HAs needed to be cross-linked using different manufacturing techniques, resulting in products that still widely vary in formulation and cross-linking degree. Among the HAs manufactured with proprietary technologies associated with specific rheological properties, the first author already employed in the year 1994 HA prefilled syringes based on Non- Animal Stabilized Hyaluronic Acid (NASHA™, Galderma Pharma S.A., Lausanne, Switzerland) technology [2]. The first papers reporting the results obtained on subjects treated with HA gels were dated around 1998 [3,4]. Since then, numerous HA fillers have constantly been developed. Consequently, many
more brands and formulations were manufactured, some of which presenting excellent results, whereas others were less effective [5,6]. In the author’s view, several HA fillers had to be only slightly modified to drastically improve their viscoelastic properties. Moreover, lidocaine was added to certain gels, which could markedly alter the gels’ viscoelastic properties compared to their formulation without any anesthetic, as previously observed [7-9]. Recently, a novel proprietary manufacturing technology for producing innovative HA fillers was elaborated, reference being here made to MaiLi’s OxiFree™ technology (Kylane Laboratoires S.A., Plan- les-Ouates, Switzerland). This new HA filler was launched by Sinclair Pharma under the name of MaiLi. Its basic principle consists in the cross-linking of the HA under inert atmosphere and the extraction of reactive oxygen upon the manufacturing process. This procedure was primarily designed to significantly preserve the intrinsic properties of the high-molecular-weight HA chains. Based on this new technology,
1
J Clin Cosmet Dermatol | JCCD
Features Before & After Results 1 2 3 Why MaiLi
Who is MaiLi for?
MaiLi Range
Published Evidence
Product Summary
Mode of Action
MaiLi
Lanluma Ellansé
PRODUCT COMPARISON
15
Published evidence for MaiLi
Journal of Clinical and Cosmetic Dermatology ISSN 2576-2826 | Open Access
Sci Forschen Open HUB for Scientific Research
This article present the efficacy and safety data from a four-centre pilot study for MaiLi Precise in correcting fine-line wrinkles of the perioral area.
RESEARCH ARTICLE Safety and Efficacy of Using MaiLi® Precise by Mean of Intradermal Injections for Correcting Perioral Fine Lines Paloma Borregón 1 , Juan Caicedo 2 , Raphaëlle Glacet 3, *, Erick Santaella 4 , and Franco Vercesi 5 1 Clínica Kalosia, Madrid, Spain 2 Cclinics, Valencia, Spain 3 Cremer Consulting, Strasbourg, France 4 ERSA Medical & Aesthetics, Monterrey, Mexico 5 Centro Medico Galeno, Milan, Italy Volume 7 - Issue 2 *Corresponding author: Raphaëlle Glacet, Cremer Consulting, 14 rue Sleidan, FR-67000 Strasbourg, France, Tel: +33 (0)3 88 35 14 72; E-mail: gmc@cremerconsulting.com
Received: 14 Dec, 2023 | Accepted: 21 Dec, 2023 | Published: 27 Dec, 2023
Citation: Borregón P, Caicedo J, Glacet R, Santaella E, Vercesi F (2023) Safety and Efficacy of Using MaiLi® Precise by Mean of Intradermal Injections for Correcting Perioral Fine Lines. J Clin Cosmet Dermatol 7(2): dx.doi.org/10.16966/2576-2826.178 Copyright: ©2023 Borregón P, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Abstract Introduction: Over the last twenty years, dermal fillers have become the backbone for rejuvenating the perioral area, which is one of the most difficult areas to treat. Due to the development of highly sophisticated fillers with radically different rheological properties and innovating techniques, it has become possible to correct specific regions with more natural results than before. This four-center pilot study sought to investigate the efficacy and safety of MaiLi® Precise in correcting fine-line wrinkles of the perioral area. Material and Methods: MaiLi® Precise is a recently introduced Hyaluronic Acid (HA) filler, harnessing the OxiFree ™ technology, for suppleness, flexibility, and high longevity. These properties were deemed particularly suitable for correcting fine-line perioral wrinkles. All injections were performed using intradermal injections, with the fluid HA injected in a very superficial manner, resulting in the formation of very small papules at the wrinkle, disappearing within 1-2 hours. Follow-up occurred at one (T1) and three months (T2) post-injection. Treatment effectiveness was evaluated using the Global Aesthetic Improvement Scale (GAIS), as was the satisfaction of the subjects and investigators. Adverse Events (AEs) were also reported. Results: Overall, 20 patients aged 56 years on average, from four centers, were injected MaiLi® Precise into the perioral area to correct perioral lines using intradermal injections. No specific safety concerns were detected, given that AEs remained mild, were almost all resolved by T1, and were completely absent by T2. Patient and physician satisfaction were both >90% during follow-up. All physicians attributed improved, much improved, or very much improved GAIS scores at T1 and T2, indicating a marked improvement in appearance after injection. Conclusion: Based on the current study results, MaiLi® Precise was shown to be safe and provided satisfactory results from both the patient and the physician’s points of view during a 3-month follow-up. Keywords: Hyaluronic acid; Perioral area; Skin rejuvenation; OxiFree™ technology; MaiLi® filler, Fine lines; Intradermal injection
Borregón P, et al. J Clin Cosmet Dermatol 2023;7(2): doi.org/10.16966/ 2576-2826.178
Introduction The perioral region refers to the lower one-third of the face, which comprises the upper and lower lips, the cheek-lip grooves or nasolabial folds, and the chin. Ageing signs at this region are among the key reasons for patients seeking treatment [1]. Indeed, this region undergoes significant changes during ageing that likely contribute to a “displeased” or “sad” expression [2]. These changes include fine wrinkling around the lips, deep nasolabial and mentolabial folds, elongation and flattening of the upper lip, downturned corners of the mouth, marionette lines, as well as chin irregularities. The perioral region is the most concerned area for facial rejuvenation. Different options exist, Hyaluronic Acids (HAs) being commonly
used [3]. Since 1998, revolumization of facial structures using HA dermal fillers has been instrumental in reducing signs of ageing and increasing attractiveness [4-6]. In the following years, many different HA filler brands and formulations were manufactured, with differing viscoelastic properties [7,8]. Lidocaine was added to certain gels to increase patient compliance [9]. This perioral region remains one of the most difficult areas to treat, owing to its highly dynamic nature. Wrinkles within the cutaneous lip areas range from fine, almost imperceptible lines to multiple deep etchings, generally referred to as barcodes. Previous attempts of correcting these areas with fillers showed that subcutaneous ridges or overcorrection may be generated in relation with the rheological properties of previous HA fillers [10].
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J Clin Cosmet Dermatol | JCCD
Features Before & After Results 1 2 3 Why MaiLi
Who is MaiLi for?
MaiLi Range
Published Evidence
Product Summary
Mode of Action
MaiLi
Lanluma Ellansé
PRODUCT COMPARISON
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Why MaiLi? To summarise…
1
2
3
Award-winning OxiFree ™ technology delivers proven long lasting effects for over 12 months 1
Outstanding projection with 24% less 2 product enables HCPs to do more with the same amount 2
MaiLi gives naturally supple results, which mimic facial movement 1
Thanks to these benefits, HCPs can expect
• Natural-looking results • More facial areas treated with the same amount of gel • Less BDDE used for crosslinking
1. Sinclair Pharma. MaiLi Physician Leaflet. 2021; 2. Sinclair Pharma. Data on file. Reference HA filler. Juvéderm Voluma.
UKBR-00862636-001-000
Features Before & After Results 1 2 3 Why MaiLi
Who is MaiLi for?
MaiLi Range
Published Evidence
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MaiLi
Lanluma Ellansé
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Lanluma is a high-performing next-generation PLLA collagen stimulator for face and body, activating natural processes to promote improved skin tightness and texture.
Features Before & After Results 1 2 3 Why Lanluma
MaiLi
Lanluma Ellansé Lanluma
PRODUCT COMPARISON
1
Who is Lanluma for? HCPs and patients who want a dependable, long-lasting, versatile product offering outstanding results across many body areas:
Face: • Full face harmonisation • Improved skin quality • Tightness & thickness
Abdomen: • Improved tissue firmness • Skin tightening effect • Reduction of skin laxity
PLLA Foundation Areas Face and abdomen Buttocks and thighs Cellulite PLLA Expert Areas Décolleté and neck Upper arms and hands
Features Before & After Results 1 2 3 Why Lanluma
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Mode of Action
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MaiLi
Lanluma Ellansé Lanluma
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2
Who is Lanluma for? HCPs and patients who want a dependable, long-lasting, versatile product offering outstanding results across many body areas:
Buttocks: • Improved shape • Strong projection • Suitable for treating hip dips
Thighs: • Reduced flaccidity • Refined skin thickness • Improved appearance
PLLA Foundation Areas Face and abdomen Buttocks and thighs Cellulite PLLA Expert Areas Décolleté and neck Upper arms and hands
Features Before & After Results 1 2 3 Why Lanluma
Product Summary
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Mode of Action
Clinical Data
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MaiLi
Lanluma Ellansé Lanluma
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2
Who is Lanluma for? HCPs and patients who want a dependable, long-lasting, versatile product offering outstanding results across many body areas:
Cellulite: • Helps to reduce the
appearance of cellulite
PLLA Foundation Areas Face and abdomen Buttocks and thighs Cellulite PLLA Expert Areas Décolleté and neck Upper arms and hands
Features Before & After Results 1 2 3 Why Lanluma
Product Summary
Training Resources
Mode of Action
Clinical Data
Safety
MaiLi
Lanluma Ellansé Lanluma
PRODUCT COMPARISON
2
Who is Lanluma for? HCPs and patients who want a dependable, long-lasting, versatile product offering outstanding results across many body areas:
Décolleté & neck: • Reduced flaccidity, sagging and wrinkles
PLLA Foundation Areas Face and abdomen Buttocks and thighs Cellulite PLLA Expert Areas Décolleté and neck Upper arms and hands
Features Before & After Results 1 2 3 Why Lanluma
Product Summary
Training Resources
Mode of Action
Clinical Data
Safety
MaiLi
Lanluma Ellansé Lanluma
PRODUCT COMPARISON
2
Who is Lanluma for? HCPs and patients who want a dependable, long-lasting, versatile product offering outstanding results across many body areas:
Upper arms: • Improved skin laxity
Hands: • Ideal for restoring
volume and skin quality in ageing hands
PLLA Foundation Areas Face and abdomen Buttocks and thighs Cellulite PLLA Expert Areas Décolleté and neck Upper arms and hands
Features Before & After Results 1 2 3 Why Lanluma
Product Summary
Training Resources
Mode of Action
Clinical Data
Safety
MaiLi
Lanluma Ellansé Lanluma
PRODUCT COMPARISON
2
Why Choose Lanluma 01
02
03
Promotes improved skin tightness & textures
Next Generation PLLA technology
Suitable for face & body
• Stable for longer than 1st-Gen comparator product 1,2 • Avoids particle separation/ settlement 1,2
• Increases volume and skin quality on face & body 3 • Protocols include face, neck & décolleté, arms, hands, thighs, buttocks and abdomen 3
• Consistently successful patient results 4 • High levels of patient satisfaction evident in clinical evaluation reports 4 • Improved skin tightness and texture in 93.3% following décolleté treatment 4
• High safety rate of 0.224% 2
• Effective on cellulite 3
1. Sinclair Pharma. Data on file; 2. Sinclair Pharma. Data on file. Evidence was gathered from adverse events reports raised with Vigilance since February 2021 to end of May 2024; 3. Sinclair Pharma. Lanluma Instructions for Use; 4. Amselem M, et al. J Cosmet Dermatol 2024;00:1-10.
Features Before & After Results 1 2 3 Why Lanluma
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MaiLi
Lanluma Ellansé Lanluma
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3
Next generation PLLA [poly-L-lactic acid] technology FEATURE 1
After reconstitution, Lanluma stays stable for longer vs competitor whose PLLA particles appear to separate and settle at the bottom and top more quickly. MORE HOMOGENOUS AND STABLE ON RECONSTITUTION
Solution stability test: 30 minutes
PLLA-SCA and Lanluma are two different products. Lanluma cannot be used the same way as PLLA-SCA. Refer to the dilution charts for full instructions for use. *Sinclair Pharma. Data on file.
Features Before & After Results 1 2 3 Why Lanluma 1
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MaiLi
Lanluma Ellansé Lanluma
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Next generation PLLA technology FEATURE 1
Studies show Lanluma remains stable for longer when compared to PLLA-SCA * BETTER, MORE PREDICTABLE RESULTS *
*Sinclair Pharma. Data on file.
Features Before & After Results 1 2 3 Why Lanluma 1
Product Summary
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MaiLi
Lanluma Ellansé Lanluma
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Suitable for face and body FEATURE 2
Two sizes. Identical composition. Results where you need them.
Lanluma V: 210mg PLLA Designed for smaller areas, e.g. face, upper arms, neck, décolleté. Face treatment typical use: ½ vial of Lanluma V compared with ¾ vial of PLLA-SCA.
Lanluma X: 630ml PLLA Designed for larger areas, e.g. buttocks, thighs, abdomen. Buttocks treatment typical use: 1 vial of Lanluma V compared with 2.4 vials of PLLA-SCA, 1 vial of Lanluma X compared with 7.5 vials of PLLA -SCA.
Lanluma V
Lanluma X
Features Before & After Results 1 2 3 Why Lanluma 2
Product Summary
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MaiLi
Lanluma Ellansé Lanluma
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Promotes improved skin tightness & texture FEATURE 3
This study showed that Lanluma improves the visible signs of skin health: • Brightness • Regeneration • Wrinkle improvement
This study showed that Lanluma supports skin health, in terms of wrinkle improvement, brightness and regeneration 1 :
Increase in expression of Collagen involved in elasticity
Decrease in expression of Collagen degrading enzyme
Improvement in Collagen density
75.54
2.94
55.08
1.62
1.04
0.59
*p<<0.05 Gana V and Lanluma are equialent products
1. Korea Biomedical research institute. KBI-XM-SKFZ-23005-1. 2024
Features Before & After Results 1 2 3 Why Lanluma 3
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MaiLi
Lanluma Ellansé Lanluma
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Promotes improved skin tightness & texture FEATURE 3
Clinical evaluation report shows patients are highly satisfied with Lanluma PLLA treatment Non-inferiority trial results: Lanluma garners higher patient satisfaction than PLLA-SCA
Lanluma V is equivalent to PLLA-SCA in reducing wrinkle severity 1
Mean WSRS
% of pa tie nts with ≥1 point scor e d e cr e a se
0 0.2 0.4 0.6 0.8 1 1.2 1.4 1.6 1.8 2
0 10 20 30 40 50 60 70 80 90 100
90.77
1.74
87.69
1.71
Lanluma V (n=65)
PLLA-SCA (n=65)
Lanluma V (n=57)
PLLA-SCA (n=59)
There was no significant difference in the WSRS after week 48 between Lanluma V and PLLA-SCA
The proportion of subjects with <-1 WSRS improvement at week 48 compared with baseline was not statistically significant
WSRS, Wrinkle Severity Rating Scale 1. Clinical Trial Report GN-CIR-01, version 1.0_20190104.
Features Before & After Results 1 2 3 Why Lanluma 3
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MaiLi
Lanluma Ellansé Lanluma
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Before & After: see the difference
Baseline
Immediately after treatment
5 weeks after treatment
INJECTOR: Dr Ana Štanfel
Face (9ml in total - 3ml cheeks, 6ml deep dermis) Cheek (Lanluma V) Lower face (Lanluma V)
Actual patient – individual results may vary
Features Before & After Results 1 2 3 Why Lanluma
Product Summary
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MaiLi
Lanluma Ellansé Lanluma
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Before & After: see the difference
Baseline
21 months post initial injection
INJECTOR: DR. FORTE, ITALY
3 doses of 2ml maximum per side given at: Initial visit (Lanluma V) 2–3 month (Lanluma V) 5–6 month (Lanluma V)
Actual patient – individual results may vary
Features Before & After Results 1 2 3 Why Lanluma
Product Summary
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Mode of Action
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Safety
MaiLi
Lanluma Ellansé Lanluma
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Before & After: see the difference Baseline
21 months post initial injection
INJECTOR: DR. AMSELEM, SPAIN
3 doses of 1 vial maximum per side given at: Initial visit (Lanluma V) 2–3 month (Lanluma V) 5–6 month (Lanluma V)
Actual patient – individual results may vary
Features Before & After Results 1 2 3 Why Lanluma
Product Summary
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MaiLi
Lanluma Ellansé Lanluma
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Before & After: see the difference Baseline
21 months post initial injection
INJECTOR: DR. AMSELEM, SPAIN
3 doses of 1 vial for the total area, given as 10–15ml per side, per indication, range 25–35ml may be used depending on the size of the area, given at:
Initial visit (Lanluma V) 2 – 3 month (Lanluma V) 5–6 month (Lanluma V)
Actual patient – individual results may vary
Features Before & After Results 1 2 3 Why Lanluma
Product Summary
Training Resources
Mode of Action
Clinical Data
Safety
MaiLi
Lanluma Ellansé Lanluma
PRODUCT COMPARISON
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Before & After: see the difference Baseline
21 months post initial injection
INJECTOR: DR. FATSEA, GREECE
Thigh/cellulite (5–10ml per thigh/cellulite) Initial visit (Lanluma V) 2 months (Lanluma V) 4 months (Lanluma V)
Inner thigh (5ml injected into a surface area of 25 cm sq) Initial visit (Lanluma V, maximum 1 vial per leg) 2 months (Lanluma V, maximum 1–2 vials per leg) 5-6 month (Lanluma V, maximum 1–2 vials per leg)
Actual patient – individual results may vary
Features Before & After Results 1 2 3 Why Lanluma
Product Summary
Training Resources
Mode of Action
Clinical Data
Safety
MaiLi
Lanluma Ellansé Lanluma
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