Figure 4 - available via license: Creative Commons Attribution 4.0 International
Content may be subject to copyright.
The clinical subject evaluation and photographs taken before treatment (left side), and three months after the beginning of the treatment (right side). A persistent improvement is clearly visible in the mid-(zygomatic and peri-orbital area) and lower-third (jawline and marionette lines) of the face.
Source publication
The aim of the case series was to determine the efficacy of a new medical device developed for adipose tissue restoration in the face. The medical device used the patented NAHYCO® Hybrid Technology to deliver 45 mg of high- (1400 ± 200 kDa) and 45 mg of low- (100 ± 20 kDa) molecular-weight hyaluronan, in 2 mL. Patients and methods: Twenty-two volun...
Context in source publication
Context 1
... instrumental evaluations were also confirmed by the patients' self-assessment, evaluated according to the Global Aesthetic Improvement Scale (GAIS) scale (5-point scale). As shown in Figure 4, the patients showed a significant reduction in wrinkles, and a clear improvement in the general skin quality that were visible especially three months after the first treatment (T3). The amelioration was also confirmed through the GAIS evaluation ( Figure 5). ...
Citations
... Cassuto et al. also demonstrated an increase in tissue thickness evaluated by US scan when HCCs (45 mg/mL) were injected into the preauricular area. Taken together, the data showed a clear improvement of the fat compartment affected by the aging process, leading to a final lipo-lifting effect and amelioration of subjects' facial appearance [41]. ...
Hyaluronic acid (HA) is a remarkably multifaceted biomacromolecule, playing a role in regulating myriad biological processes such as wound healing, tissue regeneration, anti-inflammation, and immunomodulation. Crosslinked high- and low-molecular-weight hyaluronic acid hydrogels achieve higher molar concentrations, display slower degradation, and allow optimal tissue product diffusion, while harnessing the synergistic contribution of different-molecular-weight hyaluronans. A recent innovation in the world of hyaluronic acid synthesis is represented by NAHYCO® Hybrid Technology, a thermal process leading to hybrid cooperative hyaluronic acid complexes (HCC). This review summarizes the current literature on the in vitro studies and in vivo applications of HCC, from facial and body rejuvenation to future perspectives in skin wound healing, dermatology, and genitourinary pathologies.
... The evaluation was based on scientific protocols and approaches previously developed and published in the recent scientific literature [20,21]. A clinical study was recently published on HL 90 as a retrospective case series, assessing the bioremodeling performance of these intradermal formulations when injected in the facial fat compartment of healthy volunteers [23]. However, the present research report is the first in which the rheological behavior of adipose tissue was evaluated in combination with hyaluronic acid formulations. ...
Cells and extracts derived from adipose tissue are gaining increasing attention not only in plastic surgery and for aesthetic purposes but also in regenerative medicine. The ability of hyaluronan (HA) to support human adipose stromal cell (hASC) viability and differentiation has been investigated. However, the compatibility of adipose tissue with HA-based formulation in terms of biophysical and rheological properties has not been fully addressed, although it is a key feature for tissue integration and in vivo performance. In this study, the biophysical and biochemical properties of highly concentrated (45 mg/mL) high/low-molecular-weight HA hybrid cooperative complex were assessed with a further focus on the potential application in adipose tissue augmentation/regeneration. Specifically, HA hybrid complex rheological behavior was observed in combination with different adipose tissue ratios, and hyaluronidase-catalyzed degradation was compared to that of a high-molecular-weight HA (HHA). Moreover, the HA hybrid complex’s ability to induce in vitro hASCs differentiation towards adipose phenotype was evaluated in comparison to HHA, performing Oil Red O staining and analyzing gene/protein expression of PPAR-γ, adiponectin, and leptin. Both treatments supported hASCs differentiation, with the HA hybrid complex showing better results. These outcomes may open new frontiers in regenerative medicine, supporting the injection of highly concentrated hybrid formulations in fat compartments, eventually enhancing residing staminal cell differentiation and improving cell/growth factor persistence towards tissue regeneration districts.
... In this case, increasing the amount of HA (45 mg of low molecular weight HA and 45 mg of high molecular weight HA in 2 mL) improved the resistance to degradation in a way that was similar to cross-linked HA fillers. 28 Although no instrumental investigations were possible, we can assume that the long-term improvement of FVLS and WSRS scores 4 months after the treatment assessed during the current study is dependent on the lateral cheek fat restoration effect demonstrated by recently published data by Cassuto et al. 29 In this paper, the authors specifically examined fat restoration in the lateral cheek compartment thanks to US evaluation of skin thickness and fat hyperechoic areas examinations. ...
Background and Aims
Hyaluronic acid (HA)‐based injections are used worldwide to improve skin defects associated with aging and ultraviolet light/environmental exposure. HA formulations developed according to molecular weight or with additional components, for example, cross‐linking reagents, are limited by their low biological activity and concentration limit. NAHYCO™ technology has enabled the production of hybrid cooperative complexes (HCCs) of low and high molecular weight HA. Developed for injection into the fat compartments of the face and previously demonstrating potential benefits for adipose tissue restoration, Profhilo Structura® is a new 2 mL HCC formulation comprising low molecular weight HA (45 mg/mL) and high molecular weight HA (45 mg/mL). To evaluate the efficacy and tolerability of Profhilo Structura® to restore adipose tissue compartments in the lateral cheek fat compartment.
Methods
Fifty healthy enrolled subjects received two injections, 1 month apart, and were evaluated 3 months posttreatment. Investigators performed clinical evaluations (Facial Volume Loss Scale [FVLS] and Wrinkle Severity Rating Scale [WSRS]) at different time points. Subjects also completed self‐evaluation assessments following treatment.
Results
A significant improvement in FVLS and WSRS clinical scores after the first treatment was observed; treatment benefit was maintained 3 months after treatment completion and confirmed by subject self‐assessment. Most participants reported an improvement, particularly a marked reduction of wrinkles and increased skin firmness. No serious adverse events were reported, confirming the excellent safety profile of HCC injectable devices.
Conclusions
Overall, the study highlighted the efficacy and tolerability of the studied medical device proving its effect on adipose tissue.
... These treatments include, but are not limited to, chemical peels, microneedling, and laser treatments, as well as cosmeceuticals, nutraceuticals, and minimally invasive injectables such as botulinum toxin and intradermal fillers. 3,[8][9][10][11][12][13][14][15][16][17] Importantly, many of these interventions are used in combination or have established effects on measures such as skin laxity but unproven effects on skin quality. To ensure an objective evaluation of these emerging treatments across diverse demographics in clinical trials, the development of inclusive, objective, and standardized assessment methods is essential. ...
... Although numerous biophysical techniques are utilized to measure different aspects of skin quality in studies, their lack of standardization and the need for costly technical equipment limit their practical use. [8][9][10]12,13,15,21 Although designed for objective measurements, instrumental tools are subject to operator-dependent data acquisition and interpretation, introducing subjectivity that, along with regular calibration needs, can lead to considerable intraobserver and interobserver variabilities. [22][23][24][25] Moreover, these techniques tend to focus on specific skin characteristics, such as hydration or elasticity, rather than providing an all-encompassing assessment of skin quality. ...
Background
The increasing demand for skin quality interventions in aesthetic medicine underscores the necessity for objective, evidence-based assessment tools that may be used to evaluate novel interventions or devices.
Objectives
To develop and validate a 5-point photo-numeric rating scale for assessing overall skin quality, including radiance, color evenness, and smoothness.
Methods
The IBSA (Institut Biochimique SA) Composite Skin Quality Scale was developed and underwent live validation with 88 real-world patients, chosen to encompass a broad spectrum of skin qualities and Fitzpatrick skin types. Scale validation was performed by board-certified plastic surgeons and dermatologists over 2 rounds, 2 weeks apart. Reliability was assessed via intrarater and interrater agreements, utilizing weighted kappa statistics and intraclass correlation coefficient (ICC). The scale's ability to discern a clinically relevant 1-grade difference was evaluated with 72 photo pairs.
Results
Combined intrarater reliability results showed weighted kappa values of 0.812 (right side) and 0.815 (left side), and an ICC of 0.903 for both sides, indicating almost perfect agreement. Interrater reliability ranged from substantial to almost perfect, with kappa coefficients between 0.654 and 0.853, and ICCs from 0.657 to 0.855 across all rater pairs in both rounds. The ability to detect a clinically relevant 1-point difference using the scale was established.
Conclusions
Integrating various key aspects of skin quality, the IBSA Composite Skin Quality Scale is a clinically relevant and highly reliable tool, suitable for skin assessment in clinical studies of new aesthetic technologies and products.
