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During last years, hyaluronic acid- (HA-) based dermal fillers have grown rapidly and continuously, as reported by the American Society of Aesthetic Plastic Surgery (ASAPS). In fact, HA fillers are considered the gold standard technique for soft tissue augmentation, deep skin hydration, and facial recontouring, playing a key role as an alternative...
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Background
Blindness is a rare but catastrophic complication of facial hyaluronic acid (HA) injection. Although various means to rescue visual impairment have been employed, no consensus regarding effective treatment has yet been reached. We organized a multidisciplinary team to address this emergency situation by means of endovascular hyaluronidas...
Citations
... Hyaluronidase is a necessary antidote to protect against unexpected complications, especially for HA-based fillers. 14,15 Injectable fillers have various applications in specific pathologies, such as the recovery of subcutaneous fat atrophy, a peculiarity of HIV-infected patients. 16,17 They are also used for correcting facial defects and traumatic facial injuries of all types, which can cause significant psychological discomfort and negative effects on the psyche and social life of the patient. ...
Purpose
This prospective, single-center study aims to evaluate the safety and effectiveness of NEAUVIA Intense, a PEG cross-linked polymeric hydrogel, in correcting moderate-to-severe nasolabial folds (NLF) in a routine clinical setting. The study investigates the aesthetic outcomes, patient satisfaction, and adverse events associated with the injectable filler.
Patients and Methods
Seventy patients were initially enrolled, with 60 meeting study parameters. The post-market study involved a single session treatment, employing NEAUVIA Intense on each side of the NLF. Assessments utilized the Modified Fitzpatrick Wrinkle Scale (MFWS), Global Aesthetic Improvement Scale (GAIS), and Visual Analogical Scale (VAS).
Results
The study demonstrated a statistically significant improvement in tissue depression immediately post-injection (p < 0.001), with sustained effects up to 6 months. MFWS assessments revealed that responder patients were 96.6% immediately after treatment, 76.6% one month, 48.3% after 3 months, and 28.3% at 6 months (p < 0.001). Additionally, there was a significant change in the frequency distribution of MFWS scores post-treatment (p < 0.001), with the majority of patients experiencing improvement in tissue depression. Maximum improvement was observed at 30- and 90-days post-treatment based on GAIS assessments. Patient and physician satisfaction, measured by VAS, remained stable over time, with fluctuations at 4 and 24 weeks after treatment (p < 0.001, Anova; p < 0.05, Wilcoxon). Throughout the entire follow-up duration of the patients enrolled in the study, no adverse effects related to the use of the product were observed.
Conclusion
NEAUVIA Intense proved to be an effective solution for correcting NLF, providing significant and lasting improvements in tissue depression and aesthetic outcomes. The study underscores the necessity for continuous assessment in aesthetic medicine to align outcomes with evolving patient expectations and optimize long-term results. The findings contribute to the understanding of this specific hydrogel filler and highlight the broader context of injectable fillers in comprehensive facial aesthetic strategies.
... Although the published clinical data are currently limited, the PEGDE-HA range has been subject to extensive molecular, chemical, mechanical, and histological characterization [8], [11], [12], [15], [16]. Two key features distinguish the PEGDE-HA range from other HA hydrogels on the market: PEGDE crosslinking and enrichment with l-proline and glycine. ...
BACKGROUND: Lip augmentation with hyaluronic acid (HA) hydrogels is one of the most common esthetic procedures worldwide, but requires products with an optimal balance of elasticity and cohesivity to volumize while integrating with the surrounding tissue. This case report describes the results of lip augmentation with a novel, 24 mg/mL HA hydrogel cross-linked with poly (ethylene glycol) diglycidyl (PEGDE-HA 24), and supplemented with l-proline and glycine to limit post-injection swelling. METHODS: In three separate treatment sessions (Weeks 0, 2, and 10), a 29-year-old woman requesting lip augmentation was injected with PEGDE-HA 24 as multiple superficial injections using a tenting technique. Photographs were taken before treatment and at 2-weeks, 1-month, and 5-months after the initial injection. The subject provided post-treatment updates on her experience with the hydrogel in terms of the results achieved and any adverse events experienced. RESULTS: A total of 1.0 mL PEGDE-HA 24 was injected: treatment session 1 (0.3 mL); session 2 (0.4 mL); and session 3 (0.3 mL). The day after each injection the subject reported that her lips were sensitive, but not painful. The level of post-injection bruising and swelling diminished with each subsequent injection and healed rapidly. No other adverse events were reported. The subject was very satisfied with the results describing them as attractive and natural looking for up to 5 months. CONCLUSIONS: This case report demonstrated that 1 mL of PEGDE-HA 24 was effective and well tolerated for volume augmentation of the lip. The subject was very satisfied with her experience of the hydrogel and natural-looking results were achieved.
... La luz infrarroja (IR), emitida con una longitud de onda de 750 a 1.800 nm y una densidad de energía de 5 a 75 J/ cm², al ser aplicada sobre la piel es capaz de producir un calentamiento de la dermis profunda, lo que conlleva la activación de mecanismos encaminados a la restauración cutánea [4]. ...
... Un 36% de pacientes del estudio realizaron el tratamiento con terapia combinada de tecnología de luz IR, AH estabilizado y una sesión de AH reticulado combinado con HaCa en el tercio medio facial [12,13]. Los inyectables híbridos que combinan AH con un porcentaje mínimo de HaCa potencian el efecto voluminizador y de hidratación del AH por la actividad de neocolagénesis directa por parte de la HaCa [4]. El AH reticulado utilizado en este estudio tiene como agente reticulante PEG. ...
... El AH reticulado utilizado en este estudio tiene como agente reticulante PEG. El proceso de entrecruzamiento entre estos dos polímeros, conocido como pegilación, forma un andamio molecular 3D para una mejor integración en el tejido conectivo, un efecto de relleno duradero y más resistente al estrés térmico y mecánico [4,5]. No se ha realizado tratamiento con un AH que utilice como agente reticulante BDDE (Butanodiol diglicidil éter), por lo que no se puede comparar la resistencia al estrés térmico y mecánico entre los dos tipos de agentes reticulantes. ...
Introducción. La creciente demanda de tratamientos en medicina estética para contrarrestar el proceso de envejecimiento de forma segura y efectiva ha conducido a realizar tratamientos que combinan el ácido hialurónico (AH) e inductores de colágeno como la hidroxiapatita cálcica (HaCa) con tecnologías basadas en láseres o fuentes de luz. El objetivo del presente estudio es evaluar los resultados obtenidos empleando la sinergia de un tratamiento de relleno con AH, cuyo agente reticulante es polietilenglicol (PEG), combinado con tecnología de luz infrarroja (IR) en pacientes que desean mejorar la laxitud e hidratación cutánea. Material y método. Estudio preliminar prospectivo en el que se seleccionaron 25 pacientes mujeres, con rango de edad de 37 a 68 años (promedio 48 años), con fototipos I‑IV, que deseaban prevenir y tratar la laxitud cutánea. Para su posterior valoración los pacientes se dividieron en 3 grupos de tratamiento y se analizó la variable satisfacción de forma cualitativa en todos ellos. Tratamiento 1: Formado por 6 pacientes que solo recibieron tratamiento con luz IR. Tratamiento 2: Se trataron 10 pacientes con luz IR más un híbrido de AH no reticulado (18 mg/ml) con HaCa (0,01%). Tratamiento 3: Se incluyeron 9 pacientes que se trataron de modo similar al grupo 2, pero inyectando en la última sesión en el tercio medio malar, un relleno híbrido de AH reticulado (26 mg/ml), HaCa 1%, glicina y L‑prolina. También se tuvo en cuenta si los pacientes eran mayores o menores de 50 años. Resultados. No aparecieron efectos adversos significativos. La satisfacción fue elevada en todos los grupos de tratamiento. De las 25 pacientes que participaron en el estudio, 15 (60%) eran menores de 50 años, obteniendo la mayor satisfacción (100%) las que recibieron el tratamiento 3. El 40% (10 pacientes) eran mayores de 50 años, alcanzando la mayor satisfacción (100%) las que recibieron el tratamiento 1. Conclusión. El tratamiento con luz IR en 5 sesiones, solo o combinado con AH estabilizado y con híbridos de AH e HaCa, es eficaz en el tratamiento de la laxitud cutánea alcanzando resultados muy satisfactorios con pocos efectos adversos.
... One of the main selective binding properties of S-HA is its high affinity for different cytokines and growth factors, including fibroblast growth factor (FBG), vascular endothelial growth factor (VEGF), and transforming growth factor-beta (TGF-β) [48]. These growth factors perform important roles in wound healing, tissue repair and angiogenesis, and S-HA capability to selectively bind to, and sequestering these factors can improve their bioactivity and support tissue regeneration [49]. ...
Hyaluronic acid (HA) is a non-sulfated glycosaminoglycan (GAG) that is a versatile material whose biological, chemical, and physical characteristics can be deeply tuned to modifications. However, HA is easy to decompose by hyaluronidase in vivo, and this process will reduce its structure and function stability during application. The sulfonation of HA can improve its stability under the action of hyaluronidase. Sulfated hyaluronic acid (S-HA) can be synthesized by many methods, and it shows significantly slower degradation by hyaluronidase compared with HA. In addition, negatively charged S-HA has other advantages such as anti-adhesive activity, anti-inflammatory, macromolecules by electrostatic interactions, stable site absorption of positively charged molecules, and enhancement of growth factor binding ability. It has numerous applications in medical (anti-aging, inflammation, tissue regeneration, cancer therapy, wound healing, and drug delivery) and cosmetics as biomaterials and coatings. In this article, the advances of S-HA for potential application of biomaterials and biomedical coatings will be reviewed and comprehensively discussed.
... Hyaluronidase can degrade HA hydrogels and can prevent severe vascular complications. For this reason, the immediate availability of hyaluronidase is essential for any doctor using HA fillers [12,13]. Injectable fillers have a wide range of medical indications. ...
Recently, thanks to the greater discovery of the mechanisms of facial aging, an alternative to invasive plastic surgery has found space with less invasive aesthetic procedures, also based on an increasingly pressing request. We are specifically referring to dermal filler injection into or under the skin which leads to immediate rejuvenation and aesthetic improvements. In this study, we wanted to analyze the results obtained through the use of NEAUVIA Organic Stimulate, particularly with regard to its effectiveness, which is a cross-linked polymeric hydrogel, containing stabilized sodium hyaluronate 26 mg/mL and calcium hydroxyapatite (1%), glycine and L-proline in buffer pyrogen-free water, in its main indication, namely, the temporary correction of congenital and acquired deficiencies of the soft tissues of the face by intradermal injection. Initially, 70 patients were enrolled, but 10 did not complete the study due to non-observance of the investigation rules, so they were excluded from the protocol. The collected data demonstrate an efficient mechanical effect of the pegylated polymeric acid matrix enriched with low concertation of calcium hydroxyapatite and in accordance with other evidence in vitro and in vivo, and the mechanical support of the interstitial connective space improves the homestays of the anatomical layer rebalancing the physiological activity of the dermis cells.
... The obtained results were further confirmed with in vivo and ex vivo studies [14]. In our article, a noncrosslinked HA basal structure with a wide range of amino acids (lysine, proline, leucine, isoleucine, valine, serine, and alanine), whose main property is to stimulate anabolic functions of scalp cells such as replication, protein synthesis, and production of extracellular matrix components and promoting the growth of hair follicles [15,16], was investigated using human DPCs. The experiments were carried out focusing on the possible protective effect in response to stress-inducing conditions triggered by environmental damage, as the oxidative stress related to ultraviolet (UV) radiation and the ability to promote VEGF release. ...
Dermal papilla cells (DPCs) are a source of nutrients and growth factors, which support the proliferation and growth of keratinocytes as well as promoting the induction of new hair follicles and maintenance of hair growth. The protection from reactive oxygen species (ROS) and the promotion of angiogenesis are considered two of the basal mechanisms to preserve the growth of the hair follicle. In this study, a noncrosslinked hyaluronic acid (HA) filler (HYDRO DELUXE BIO, Matex Lab S.p.A.) containing several amino acids was tested with in vitro assays on human follicle dermal papilla cells (HFDPCs). The experiments were carried out to investigate the possible protection against oxidative stress and the ability to increase the vascular endothelial growth factor (VEGF) release. The results demonstrated the restoration of cell viability against UVB-induced cytotoxicity and an increase in the VEGF secretion. These data demonstrate the capability of the product to modulate human dermal papilla cells, suggesting a future use in mesotherapy, a minimally invasive local intradermal therapy (LIT), after further clinical investigations.
... Marketed as a 'fully organic' product, Neauvia ™ HAs are not synthesized from the streptococcal species typical of other HA fillers, but instead by Bacillus subtilis, a bacterium widely used in probiotic supplements. These HAs are then crosslinked with polyethylene glycol, creating a biocompatible hydrogel [13]. Lastly, Juvederm ™ has recently introduced Volux, a thicker HA with a concentration of 25 mg/mL, for lower face (jawline and chin) augmentation. ...
Since the approval of the United States’ first hyaluronic acid (HA) filler in December 2003, HA fillers have become mainstays of soft tissue augmentation due to their favorable safety profile and minimally invasive treatment nature. The past two decades have not only brought an expansion in the popularity of HA fillers, but also in the number of available HA filler products and indications for cosmetic enhancement. Accordingly, HA filler injection has become one of the most commonly performed cosmetic procedures worldwide. The progression of HA filler products is a study in both biomedical engineering advancements, as well as evolving concepts of beauty and cosmesis. In this chapter, we review the history of these products, including their composition and indications for use. We then explore the prospect of HA fillers for the future of esthetic medicine, as they remain a vital component of nonsurgical soft tissue augmentation.
... Another important issue arisen is related to the long-lasting effect of these fillers: Zerbinati et al. in their study performed several punch biopsies in previously injected areas, 8 months earlier, and noted the filler harmoniously integrated with the structures inside the connective tissue, as collagen fibers, blood, and lymphatic vessels, glands and nerves [11], [25]. The PEGylation process seems to reduce HA sensibility to HYAL [26]. In the present study, we clinically confirmed this issue: We noted a really longlasting result, even when the follow-up was up to 2 years. ...
... Clinical outcomes of the present article, showing in a 3-year period no granuloma, foreign body reaction, or other complications, confirm clinically the high safety profile and the high biocompatibility, as already previously shown by histological and in vitro studies released by Zerbinati et al. [25], [26] of PEGylated HA fillers with also long-lasting result. ...
BACKGROUND: Hyaluronic acid fillers are the most used worldwide, thanks to the high biocompatibility and safety profile of HA and it is also the only substance that can be “dissolved” due to the hyaluronidase effect. AIM: A retrospective clinical evaluation of the outcomes following PEG cross-linked HA-based filler injection was performed. METHODS: Data were collected from December 2017 to June 2020. A total of 65 patients (12 M, 53 F), age ranging 28–62 year’s old (mean age 42.3), were treated. Exclusion criteria were applied and in accord to treatment plan, were used specific site injections and fillers. Follow-up was evaluated between 6 months and 2 years. RESULTS: A total of 61 treatments using 124 vials of HA filler crosslinked with PEG were performed. CONCLUSION: In conclusion, from 2014, HA fillers having PEG as cross-linker agent have been introduced in the european market. Several papers have been published in order to evaluate the features of these fillers, although, to the best of our knowledge, this is the first clinical paper regarding their use.
... HA injections, similar to fatty tissue transfer reconstructive outcomes, could achieve outstanding, natural, and symmetrical aesthetical results, with the advantage of avoiding surgical procedures or anesthesia. Moreover, HA fillers have a low adverse event profile, because of the existence of an antidote, hyaluronidase [89][90][91][92][93][94][95]. ...
... Thus, a 26 mg/mL, PEGDE cross-linked, HA hydrogel (Neauvia Organic Intense Flux, Matex Lab, Lugano, Switzerland) was used in order to spread evenly in the subcutaneous tissue and to not be "heavy" on the skin of the area. In fact, a biomimetic filler PEGDE crosslinked was used-a new technology able to give products a high level of biocompatibility, an excellent rheological ratio, high tolerability profile, and optimal biointegration in the connective tissue of the skin [94,95]. These features make this filler suitable for our reconstructive approach. ...
... Moreover, in the present case, the use of a temporary reconstructive solution led to the search for a gel with outstanding advantages for longevity. The metabolism of PEGDE, according to its properties, reduces the action of the proteolytic enzymes as hyaluronidase increases the duration of the implant [94], with a lower need to repeat the injection after the first treatment, as demonstrated by the sable result at the 6-month follow-up. ...
The use of hyaluronic acid (HA) injectable fillers has become increasingly widespread in facial recontouring and rejuvenation. We report our experiences to emphasize the role of HA fillers as tools beyond aesthetic treatments in cases of post-surgical facial sequelae. HA fillers are generally used for aesthetic rejuvenation, but one potential new horizon could be their application in trauma, reconstructive, and craniofacial surgery. This study was conducted retrospectively, evaluating medical reports of patients treated at the Maxillofacial Surgery Unit, University of Campania “Luigi Vanvitelli”, Naples, for lip incompetence, trauma, oncological, reconstructive, and craniosynostosis surgery sequelae. Visual analog scale (VAS) evaluation was performed to assess patient satisfaction. No major complications (i.e., impending necrosis or visual loss) were reported. Bruising and swelling was reported for 48 h after lip injection. At the immediate VAS evaluation, 67% of the patients were “extremely satisfied” and 33% “satisfied”. In those 33%, VAS scores changed to “extremely satisfied” at 6–9 weeks and 3–6 months of VAS evaluation (contextually to improvement in tissue flexibility, elasticity, and aesthetic appearance). Results indicate that this minimally invasive approach achieves a high level of aesthetic enhancement, improving patient satisfaction. The concept of HA filler applications could be a frontier that may be applicable to other areas of reconstructive facial plastic surgery.
... [20][21][22][23] Hyaluronic acid-based fillers represent in fact the safest option since the availability of hyaluronidase, if properly administered, is able to solve even severe vascular complications. [24][25][26][27] Nevertheless, this solution is not permanent, and patients need to repeat the injections over time to maintain the desired result. 1 Several attempts to obtain permanent lip enhancement have been described, such as the use of silicone lip implants or the offlabel use of permanent fillers. During the 1980s and 1990s, and in the early 21st century, a great number of lip augmentation procedures were performed using permanent fillers with promising results. ...
Over the years, several techniques have been introduced to obtain permanent lip enhancement, such as the use of silicone lip implants or the off-label use of permanent fillers. Although some reports indicate that permanent lip filler is safe, many others describe early- and late-onset complications. The main issue with permanent lip fillers is the lack of a standard technique to correct undesirable results. The aim of this scoping review was to list and evaluate the surgical pathways described in literature to correct lip deformity resulted from the injection of permanent fillers. The methods and the inclusion criteria of this work were specified in advance and documented in a protocol, according to the PRISMA 2009 checklist. The research was carried out on electronic databases PubMed, Cochrane Library, and Scopus databases identifying articles from March 1991 to December 2020 and conducted up to December 23rd, 2020. Articles language was limited to English. The selection process identified 3 retrospective studies eligible for inclusion. 73 patients and a total of 111 lips (72 upper and 39 lower) were considered. Two early complications were identified, 1 suture dehiscence and 1 total lip mucosa necrosis. Surgical lip remodeling following permanent filler injection seems to be an effective approach although the surgical pathway needs to be customized per each patient. Complication rate seems to be coherent to lip surgery performed with reconstructive purposes. To confirm these data case-control studies with much wider cohorts are needed to reach statistical significance.
