Profhilo Structura® is a new medical device which uses the patented NAHYCO® Hybrid Technology to deliver 45 mg of high- (1400 ± 200 kDa) and low- (100 ± 20 kDa) molecular-weight HA. NAHYCO® Hybrid Technology has already shown a significant contribution to improving the fibroblast function and skin elasticity, both in vitro and during clinical studies, with an optimal safety profile . In particular, Profhilo Structura® is an innovative formulation which has demonstrated a durability comparable with cross-linked HA fillers, with a higher safety profile The HCC high tolerability has also been demonstrated by a long-term safety study involving seven injections of the treatment in one year . Moreover, it has also been demonstrated that Profhilo® also plays pivotal roles in enhancing the viability of human ASCs, and stimulating adipogenic differentiation
The present work is a retrospective case series, which aims to assess the bioremodeling performance of the studied medical device on the facial fat compartment of healthy volunteers, injected into the superficial fat compartment along the line from the preauricular area to the mandibular angle.
The in vitro results have demonstrated that Profhilo Structura® is highly cohesive and spreadable, while it shows a lower viscosity compared to cross-linked HA dermal fillers. In this regard, the data indicate a pseudoplastic consistency that allows for easy extrusion from a syringe.
Moreover, the instrumental and clinical data taken after subjects’ treatments have demonstrated that Profhilo Structura® shows high filling abilities, rendering this innovative product particularly attractive. In this context, the gel is able to optimally spread and integrate into the interstitial spaces of the adipose tissue, as demonstrated in qualitative images obtained via US scans. The US scan data on the adipose tissue restoration and repositioning after treatment with Profhilo Structura® confirmed the in vitro findings on adipogenic differentiation from Stellavato et al. In particular, Stellavato et al. demonstrated that HCC plays an effective role in inducing the proliferation and differentiation of hASCs into adipocytes, compared to linear and cross-linked HA. The present article further highlights the role of HCCs and, in particular, of Profhilo Structura® in adipose tissue restoration and repositioning in a clinical setting.
Profhilo Structura® is the first available injectable filler with a specific indication for adipose tissue restoration, and is able to counteract facial volume loss. In this regard, the only other injectables currently available on the market able to counteract facial volume loss are represented by poly-L-lactic acid (PLLA) fillers. However, PLLA fillers are indicated for intradermal injections, and they also display a different mechanism of action to Profhilo Structura®, involving fibroblast recruitment and collagen production . More importantly, PLLA fillers are not able to directly restore the fat tissue compartment, and they are not always free from complications, such as foreign body reactions (nodules and granulomas) Despite further evaluations being needed, in order to better characterize adipogenic markers, such as leptin, PPAR-γ, LPL, and adiponectin, after treatment with Profhilo Structura®, and to better investigate its long-term efficacy, this medical device could represent an effective and safer treatment for fat-tissue improvement, compared to lipofilling. Although lipotransfer is the best-known method used in fat-tissue grafting, it represents a difficult and invasive technique, with potential serious adverse events
Taken together, our data prove Profhilo Structura® as a novel and promising treatment for adipose tissue restoration and repositioning.
In particular, the quantitative analysis on skin thickness also demonstrated a general improvement in the injection area immediately after treatment and, more importantly, three months after treatment. Importantly, the quantitative results shows that the medical device not only has an immediate benefit, but that this is also maintained over time. The results have also been confirmed by clinicians and through patients’ satisfaction, as assessed by the high score evaluation on the GAIS scale.
Overall, these data demonstrate that the studied medical device shows optimal tissue integration, and has a crucial regenerating effect on the adipose tissue, leading to more relaxed skin, and a compacted area after treatment. These clinical outcomes may provide the rationale for positioning the medical device within a biorevolumetry approach, due to three simultaneous actions: an increase in the volume, a lipolifting effect, and the stimulation of adipogenic differentiation. More importantly, ProfhiloStructura® allows the preservation of a natural look, and aesthetic effects similar to those obtained using cross-linked dermal fillers, avoiding any adverse effects associated with the use of different molecules from HA or other chemical molecules, and showing a high safety profile.