Study of biological markers in skin quality treatment by subcutaneous injection of a stabilized composition of 26 mg/mL of high molecular weight HA

Bétemps, Jérémie Bon; Molliard, Samuel Gavard; Hadjab, Basste; Badi, Mhd; Ghazal, Anas; Cerrano, Marco

doi:10.20517/2347-9264.2022.61

Cited by 3 publications

(2 citation statements)

References 13 publications

(24 reference statements)

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“…Namely, enhanced hydrogel system resilience and distinctive projection capacities were previously reported for OxiFree™-based products compared to alternative commercial dermal fillers [19,20]. Specifically, such attributes are derived through an optimized manufacturing process, which may be broken down into four main phases, as follows [23]: In addition, noteworthy clinical advantages were previously set forth around this dermal filler technology, comprising the sparing use of hydrogel for patient treatment, based on the enhanced functional parameters conferred by specific viscoelasticity attributes [18][19][20][21]. From a formulation viewpoint, it should be noted that manufacturers are legally required to declare the concentration of HA in their dermal filler products (Table 1).…”

Section: Technical Benchmarking Of Maili ® Dermal Filler Product Attr...mentioning

confidence: 99%

“…Contrasting with such findings, preliminary in-use clinical feedback by the practicing co-authors reported no tangible discrepancies or differences in the in vivo injection characteristics of several MaiLi ® product variants (i.e., MaiLi ® Precise, Define, Volume, Extreme; Oxi-Free™ manufacturing technology) [17]. Based on such subjective reports of qualitatively and quantitatively enhanced injectability attributes and building on previous scientific works, prospective investigations of MaiLi ® dermal fillers in terms of in-use behaviour were warranted [1,[18][19][20][21]. Specifically, a key design interest of the new study was to compare in vitro and in vivo MaiLi ® product injectability (i.e., during clinical facial dermal filling) to maximize the translational and clinical relevance of the obtained datasets.…”

Section: Introductionmentioning

confidence: 99%

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Comprehensive Evaluation of Injectability Attributes in OxiFree™ Dermal Fillers: MaiLi® Product Variants and Clinical Case Reports

Micheels,

Porcello,

Bezzola

et al. 2024

Gels

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Dermal filler injectability is a critical factor for commercial product adoption by medical aesthetic professionals and for successful clinical administration. We have previously reported (in vitro and ex vivo) cross-linked hyaluronic acid (HA)-based dermal filler benchmarking in terms of manual and automated injectability requirements. To further enhance the function-oriented product characterization workflows and the clinical relevance of dermal filler injectability assessments, the aim of this study was to perform in vivo evaluations. Therefore, several variants of the MaiLi® product range (OxiFree™ technology) were characterized in vitro and in vivo in terms of injectability attributes, with a focus on hydrogel system homogeneity and ease of injection. Firstly, standardized in vitro assays were performed in SimSkin® cutaneous equivalents, with variations of the clinical injector, injection site, and injection technique. Then, automated injections in SimSkin® cutaneous equivalents were comparatively performed in a texture analysis setup to obtain fine-granulometry injection force profile results. Finally, five female participants were recruited for the in vivo arm of the study (case reports), with variations of the clinical injector, injection site, and injection technique. Generally, the obtained quantitative force values and injection force profiles were critically appraised from a translational viewpoint, based on discussions around the OxiFree™ manufacturing technology and on in-use specialized clinician feedback. Overall, the present study outlined a notable level of homogeneity across the MaiLi® product range in terms of injectability attributes, as well as consistently high ease of administration by medical aesthetic clinicians.

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Section: Technical Benchmarking Of Maili ® Dermal Filler Product Attr...mentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Comprehensive Evaluation of Injectability Attributes in OxiFree™ Dermal Fillers: MaiLi® Product Variants and Clinical Case Reports

Micheels,

Porcello,

Bezzola

et al. 2024

Gels

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In vitro study of the gel cohesivity and persistence to hyaluronidase degradation of a novel stabilized composition of 26 mg/mL of high molecular weight HA

Finke,

Betemps,

Molliard

2024

Plast Aesthet Res

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Aim: Hyaluronic acid (HA) is extensively used in injectable skin quality products due to its documented role in skin rejuvenation. The rapid in vivo degradation of HA by the enzyme hyaluronidase necessitates the development of advanced formulations to ensure the efficacy and longevity of the treatments. In this context, a novel 2.6% high molecular weight HA (H-HA)/3.2% sorbitol composition has been introduced, featuring stabilization through hydrogen bonds rather than traditional crosslinking. Methods: The stabilized composition was evaluated through two in vitro enzymatic degradation tests. In the first test, the efficiency on the gel degradation was followed by rheology and compared with two crosslinked HA products available on the market. In the second test, the effect on the gel structure of a less diluted hyaluronidase dose was followed by rheological and cohesivity measurements. Results: In vitro study demonstrates that, before its complete degradation into a liquid-like state, the stabilized composition exhibits high elasticity and cohesivity during the enzymatic degradation process, surpassing traditional crosslinked HA products. Conclusion: The stabilization provided by the sorbitol in the stabilized composition effectively enhances product properties and protects them during gel degradation. These attributes indicate significant potential for improved clinical outcomes in skin quality treatments.

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Preparation and Rheological Evaluation of Thiol–Maleimide/Thiol–Thiol Double Self-Crosslinking Hyaluronic Acid-Based Hydrogels as Dermal Fillers for Aesthetic Medicine

Chu,

Cheng,

Wen

et al. 2024

Gels

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This study presents the development of thiol–maleimide/thiol–thiol double self-crosslinking hyaluronic acid-based (dscHA) hydrogels for use as dermal fillers. Hyaluronic acid with varying degrees of maleimide substitution (10%, 20%, and 30%) was synthesized and characterized, and dscHA hydrogels were fabricated using two molecular weights of four-arm polyethylene glycol (PEG10K/20K)–thiol as crosslinkers. The six resulting dscHA hydrogels demonstrated solid-like behavior with distinct physical and rheological properties. SEM analysis revealed a decrease in porosity with higher crosslinker MW and maleimide substitution. The swelling ratios of the six hydrogels reached equilibrium at approximately 1 h and ranged from 20% to 35%, indicating relatively low swelling. Degradation rates decreased with increasing maleimide substitution, while crosslinker MW had little effect. Higher maleimide substitution also required greater injection force. Elastic modulus (G′) in the linear viscoelastic region increased with maleimide substitution and crosslinker MW, indicating enhanced firmness. All hydrogels displayed similar creep-recovery behavior, showing instantaneous deformation under constant stress. Alternate-step strain tests indicated that all six dscHA hydrogels could maintain elasticity, allowing them to integrate with the surrounding tissue via viscous deformation caused by the stress exerted by changes in facial expression. Ultimately, the connection between the clinical performance of the obtained dscHA hydrogels used as dermal filler and their physicochemical and rheological properties was discussed to aid clinicians in the selection of the most appropriate hydrogel for facial rejuvenation. While these findings are promising, further studies are required to assess irritation, toxicity, and in vivo degradation before clinical use. Overall, it was concluded that all six dscHA hydrogels show promise as dermal fillers for various facial regions.

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Study of biological markers in skin quality treatment by subcutaneous injection of a stabilized composition of 26 mg/mL of high molecular weight HA

Cited by 3 publications

References 13 publications

Comprehensive Evaluation of Injectability Attributes in OxiFree™ Dermal Fillers: MaiLi® Product Variants and Clinical Case Reports

Comprehensive Evaluation of Injectability Attributes in OxiFree™ Dermal Fillers: MaiLi® Product Variants and Clinical Case Reports

In vitro study of the gel cohesivity and persistence to hyaluronidase degradation of a novel stabilized composition of 26 mg/mL of high molecular weight HA

Preparation and Rheological Evaluation of Thiol–Maleimide/Thiol–Thiol Double Self-Crosslinking Hyaluronic Acid-Based Hydrogels as Dermal Fillers for Aesthetic Medicine

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