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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. [ABSTRACT FROM AUTHOR]

Although permanent fillers have been introduced in order to get long-lasting results, many studies have shown numerous severe and disfiguring complications. Nonsurgical procedures may mitigate those adverse events but the only way to remove the filler previously injected is represented by surgical excision. We present a pathway of facial surgical accesses to be performed achieving two goals: permanent filler removal and restore facial aesthetic balance. The proposed surgical accesses are already standardized in aesthetic surgical practice in order to avoid direct excision and unpleasant facial scar. A total of 231 patients underwent surgery for permanent filler removal and aesthetic restoration of the involved facial area, represented by forehead, glabella, nose, cheeks, eyelids, chin, jawline, and lips. Magnetic resonance evaluation was performed with the exception of lip patients who were evaluated with ultrasound. Postoperative follow-up was 12 months to 6 years. Subjective and objective methods were used for outcome evaluation according to the FACE-Q questionnaire. Functional and aesthetic correction was scored using the patient-graded Global Aesthetic Improvement Scale (GAIS), overall patient satisfaction was assessed by a five-point scale questionnaire. Functional and aesthetic restoration was globally recognized as improved according to the GAIS. Patients reported high levels of satisfaction assessed by a five-point scale questionnaire. A very good satisfaction level was registered in both subjective and objective judgment scores. To the best of our knowledge, we present the largest case series regarding surgical removal of permanent facial fillers. A proper preoperative evaluation, filler removal followed by restorative facial aesthetic surgery technique is paramount to approach challenging cases. [ABSTRACT FROM AUTHOR]

This document discusses a case study involving a patient with varicose veins and bleeding in the foot. The patient underwent a minimally invasive ultrasound-guided sclerotherapy procedure, which involved injecting foam into the varicose vein to close it off. Compression therapy was administered afterward, and the patient experienced complete healing of the bleeding incrustation. The document emphasizes the effectiveness and safety of these interventions for managing cases of venous hemorrhage, particularly for patients with recurrent varices or those who prefer non-surgical options. [Extracted from the article]

The aim of this study was to test the effect of hyaluronic acid cross-linked with polyethylene glycol containing micronized portions of calcium hydroxyapatite (Neauvia Stimulate) on both local tissue and systemic consequences, which are crucial from the perspective of long-term safety, in patients suffering from Hashimoto's disease. This most common autoimmune disease is a frequently mentioned contraindication to the use of fillers based on hyaluronic acid as well as biostimulants based on calcium hydroxyapatite. Broad-spectrum aspects of histopathology were analyzed to identify key features of inflammatory infiltration before the procedure and 5, 21, and 150 days after the procedure. A statistically significant effect on the reduction of the intensity of the inflammatory infiltration in the tissue in relation to the state before the procedure was demonstrated, combined with a reduction in the occurrence of both antigen-recognizing (CD4) and cytotoxic (CD8) T lymphocytes. With complete statistical certainty, it was demonstrated that the treatment with Neauvia Stimulate had no effect on the levels of these antibodies. All this corresponds with the risk analysis that showed no alarming symptoms during the time of observation. The choice of hyaluronic acid fillers cross-linked with polyethylene glycol should be considered justified and safe in the case of patients suffering from Hashimoto's disease. [ABSTRACT FROM AUTHOR]

(1) Background: Cosmeceuticals are formulas enriched with active ingredients that exert efficacy on different skin molecular targets. (2) Methods: Cell viability and the absence of potential irritant risk were evaluated on keratinocytes (HaCaT), fibroblasts (NHDF), adipocytes (3T3-L1), sebocytes (PCi-SEB_CAU) and reconstructed human epidermis (RHE), respectively. Several treatments were performed to evaluate the ability of the lotion to stimulate the production of collagen and elastin, stimulate the differentiation of keratinocytes and reduce the number of senescent cells following UVB stimulation. In addition, the modulation of genes involved in the production, storage and accumulation of sebum were investigated. (3) Results: The results obtained demonstrated the biosafety of the formula in all cell lines tested. The 24-h treatment with non-cytotoxic concentrations determined an increase in the expression of the collagen (COL1A1), elastin (ELN) and involucrin (IVL) genes, while a reduction of peroxisome proliferator-activated receptor-gamma (PPARγ) gene expression and a reduction of SA-βgal-positive cells were found. Moreover, the treatment did not interfere with normal steroid 5-alpha reductase (5RDA3) gene expression levels. (4) Conclusions: Data collected demonstrated the biosafety of the lotion, the non-comedogenic property and a multi targets anti-aging effect. In particular, data collected on the booster lotion make it a valid way to counteract the pore dilatation aging related. [ABSTRACT FROM AUTHOR]

(1) Background: recently, the use of alcohol-based hand sanitizers (ABHSs) has become very frequent, and an evaluation of the stability and effectiveness of their formulations is a critical topic which should be carefully considered. (2) Methods: starting from the characterization of the hand sanitizers object of the study, our interest was focused on their rheological behavior in order to confirm their intrinsic features, but also the stability of each formulation in different conditions of shear and temperature; the second aspect concerns the antimicrobial assessment through a panel of in vitro and in vivo experimental trials. (3) Results: rheological investigation confirmed good stability for the two hand sanitizers in gel formula with respect to the reference in liquid formula; the antimicrobial activity evaluation showed good efficacy of each formulation both in vitro and in vivo. (4) Conclusions: altogether, our overview presents a valid quality control assessment to ensure the stability and efficacy of an alcohol-based hand sanitizer. [ABSTRACT FROM AUTHOR]

Background: The face is the area most exposed to the normal course of skin aging, both intrinsically and extrinsically. The aim of the study was to evaluate the cellular and clinical response of a therapeutic protocol aimed at countering facial skin aging. Materials and Methods: Twenty female patients with facial skin laxity and photodamage underwent combined therapy including mesotherapy using non-cross-linked hyaluronic acid with calcium hydroxyapatite and an infrared energy-based device treatment with subsequent implementation of PEG-cross-linked hyaluronic acid soft tissue fillers. To evaluate the benefits, patients underwent histological, immunological, and biomechanical evaluations before the treatment and at 21 and 150 days after the treatment. Results: The histological results at 21 days and 150 days after the procedure showed an increase in the number of fibroblasts and angiogenesis. As for the immunological aspect, it was shown that the treatment has an immunomodulating action, avoiding the activation of CD4 and CD8 cells. Biomechanical data showed that, at 150 days after treatment, the average changes in skin elasticity increased by 72% and the skin hydration increased by 49%. Conclusions: A combination of an infrared energy-based device treatment with both non-cross-linked hyaluronic acid and novel PEG-cross-linked hyaluronic acid leads to numerous positive cutaneous changes after histological, immunological, and biomechanical evaluations. [ABSTRACT FROM AUTHOR]

(1) Background: Dermal fillers are commonly used in aesthetic practice and their rheological characterization is of much interest today, as well as the stability study of the finished formula against external stimuli of a different nature (biological and physicochemical). Rheological tools have been exploited to characterize the physiochemical behaviour of a hyaluronic acid (HA) based dermal filler subjected to different thermal conditions over time. The collected results provide an index of its rheological stability. (2) Methods: After a preliminary Amplitude sweep test, the Frequency sweep test was performed in order to study the stability of a HA dermal filler cross-linked with Polyethylene Glycol Diglycidyl Ether (PEGDE) and containing Calcium Hydroxyapatite (CaHA), Glycine and L-Proline subjected to different conditions. Also, a shear rate ramp test was performed in order to investigate the filler's flow behavior. (3) Results and Conclusions: G' (elastic modulus), G" (viscous modulus) and consequentially tan δ (tangent of the phase angle) show a similar trend at different thermal conditions, underlining that the product is not affected by the storage conditions. The viscosity of the dermal filler decreases with an increasing shear rate, so a non-Newtonian shear thinning pseudoplastic behavior was demonstrated in all tested conditions. [ABSTRACT FROM AUTHOR]

Glioblastoma multiforme (GBM) is one of the most frequent and aggressive primary tumors in the central nervous system, representing more than 60% of all brain tumors in adults. Primary GBM remains incurable with a poor prognosis both for limited therapeutic alternatives and for a high risk of progression or recurrence. In fact, at recurrence, the few treatment options available, and often characterized by limited effectiveness, have always been an Achilles' heel. The recent approval of second line of regorafenib, a multikinase inhibitor, has given hope after several years of darkness for new therapies in the treatment of GBM. Indeed, in the REGOMA trial, a phase 2 study, regorafenib was the first drug to show a statistically significant improvement in median overall survival compared with lomustine group, usually used in the second-line treatment after temozolomide failure. We report a case of a 43-year-old patient affected by GBM in treatment with regorafenib in third line of therapy with good disease control and long PFS. [ABSTRACT FROM AUTHOR]

Differentiated thyroid cancer (DTC) includes papillary and follicular carcinomas and is the most common type of thyroid cancer. The incidence of this cancer has increased in the last few years, and even if its prognosis is generally good for a subset of patients that does not respond to radioactive iodine (RAI) therapy, the prognosis is much worse: the median overall survival (OS) from discovery of metastasis is 3–5 years and the 10-year survival rate is only 10%. Several mutations, including RAS or RET, as well as BRAF signaling, are associated with thyroid cancer. Liquid biopsy may be useful in selected patient to identify genomic alterations and thus allowing for a precision medicine approach with target therapy. Sorafenib, an oral multi-kinase inhibitor, can be used in the treatment of DTC. Case presentation: A 77 years old. man with diagnosis of metastatic DTC and evidence of presence of mutation of BRAF K601E on liquid biopsy was treated with sorafenib, showing a good response to the treatment and an improvement in the quality of life (QoL). Currently, this patient is still on treatment with sorafenib, gaining control of a multi-metastatic disease, generally characterized by a very poor prognosis. In conclusion, sorafenib has an active role in the treatment of DTC. It also has been considered the standard of care for patients with advanced unresectable hepatocellular carcinoma (HCC) and renal cell carcinoma (RCC). In our case we observe the efficacy of using sorafenib in Papillary thyroid carcinoma (PTC) such as confirming both stable disease (SD) in the CT scan as clinical benefit with an increase in QoL. Therefore, use of sorafenib remains an important treatment option, even in case of BRAF mutation, despite a rapidly evolving treatment landscape. It also seems important to perform liquid biopsies, especially in patients in whom it is not possible to repeat a new tissue biopsy. Ongoing clinical trials continue to evaluate sorafenib in different settings, and in combination with other therapies in DTC and HCC. [ABSTRACT FROM AUTHOR]

Temporary facial nerve palsy after parotid tumor surgery ranges from 14 to 65%, depending on surgery, tumor type, and subsite. The study aimed to evaluate the role of Kabat physical rehabilitation in the outcomes of patients affected by severe facial nerve palsy following parotid gland surgery. The results and clinical data of two groups, Kabat and non-Kabat (control), were statistically compared. Descriptive statistics, the multiple linear regression model, difference in difference approach, and the generalized linear model were used. F-Test, Chi-square test, McFadden R-squared, and adjusted R-squared were used to assess the significance. The results showed that the House–Brackmann (HB) stage of patients who had physiotherapy performed were lower than the control group. The decrease of HB staging in the Kabat group at 3 months was −0.71 on average, thus the probability of having a high HB stage decreased by about 13% using Kabat therapy. The results are statistically significant, and indicated that when the Kabat rehabilitation protocol is performed, mainly in the cases of a high-grade HB score, the patients showed a better and faster improvement in postoperative facial nerve palsy. [ABSTRACT FROM AUTHOR]

Background: The wellbeing of oral lichen planus patients (OLPs) may be strongly influenced by a poor quality of sleep (QoS) and psychological impairment. The aims were to analyze the prevalence of sleep disturbance, anxiety, and depression in OLPs and to validate the Pittsburgh Sleep Quality Index (PSQI) in OLPs. Methods: Three hundred keratotic OLPs (K‐OLPs), 300 with predominant non‐keratotic OLP (nK‐OLPs), and 300 controls were recruited in 15 Italian universities. The PSQI, Epworth Sleepiness Scale (ESS), Hamilton Rating Scales for Depression and Anxiety (HAM‐D and HAM‐A), Numeric Rating Scale (NRS), and Total Pain Rating Index (T‐PRI) were administered. Results: Oral lichen planus patients had statistically higher scores than the controls in the majority of the PSQI sub‐items (p‐values < 0.001**). Moreover, OLPs had higher scores in the HAM‐D, HAM‐A, NRS, and T‐PRI (p‐values < 0.001**). No differences in the PSQI sub‐items' scores were found between the K‐OLPs and nK‐OLPs, although nK‐OLPs suffered from higher levels of anxiety, depression, and pain (p‐values: HAM‐A, 0.007**, HAM‐D, 0.009**, NRS, <0.001**, T‐PRI, <0.001**). The female gender, anxiety, depression (p‐value: 0.007**, 0.001**, 0.020*) and the intensity of pain, anxiety, and depression (p‐value: 0.006**, <0.001**, 0.014*) were independent predictors of poor sleep (PSQI > 5) in K‐OLPs and nK‐OLPs, respectively. The PSQI's validation demonstrated good internal consistency and reliability of both the total and subscale of the PSQI. Conclusions: The OLPs reported an overall impaired QoS, which seemed to be an independent parameter according to the regression analysis. Hence, clinicians should assess QoS in OLPs and treat sleep disturbances in order to improve OLPs management. [ABSTRACT FROM AUTHOR]

The "Vaccines and Related Biological Products Advisory Committee 17 December 2020 Meeting Briefing Document", formulated by the FDA, reported three cases of swelling in areas previously injected with HA filler, introducing the possible relationship between a COVID-19 vaccine and adverse events in areas previously injected with HA fillers. The aim of this research is to report a case of an adverse event following a COVID-19 vaccine in a patient previously injected with facial filler. Furthermore, a scoping review on the same topic was performed. The research was carried out on the electronic databases PubMed, Cochrane Library, Web of Science, Google Scholar and Scopus. The selection process identified four articles as eligible for inclusion in the review. Nineteen patients, including the described case report, who experienced an adverse event following a COVID-19 vaccine in areas previously injected with facial filler were identified. Adverse events following a COVID-19 vaccine in patients previously injected with facial filler appear to be rare. A high BDDE cross-linking rate and/or a low-molecular-weight hyaluronic acid filler may have a higher tardive adverse event rate when triggered. [ABSTRACT FROM AUTHOR]

Physiological ageing due to the passing of time and prolonged exposure to harmful sun rays generate wrinkles and reduce skin elasticity. These visible and clinical signs can be prevented or reversed by known strategies, such as the daily use of cosmetic products with antioxidant combinations or retinoids. A new dermocosmetic formulation enriched with a complex of retinoids, called RETINOIDS SERUM, was investigated through in vitro assays using human skin cells. The experiments were carried out to assess the anti-ageing activity in normal human dermal fibroblasts (NHDF) and epidermal keratinocytes (HaCaT). After the preliminary MTT assay, the proliferation together with the synthesis of collagen and elastin fibers was performed on NHDF cells after 24 h treatment with the two non-cytotoxic concentrations. Using UVB-irradiated HaCaT cells, the measurement of matrix metalloproteinase-1 (MMP-1) levels was also investigated. In vitro studies show that the dermocosmetic product improves collagen and elastin synthesis and the renewal of dermal fibroblasts. Moreover, a reduction in the MMP-1 secretion was also highlighted in UVB-irradiated HaCaT cells. These results suggest that the cosmetic formulation containing functional compounds such as retinoids can be useful to prevent the natural sign of ageing. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

(1) Background: There is an increasing demand for a reversal of the aging process and, nowadays, more patients are seeking minimally invasive methods instead of surgery to meet this goal. The purpose of this paper is to evaluate the predictability of the off-label aesthetic use of botulinum toxin type A (BoNTA) reconstituted with lidocaine. (2) Methods: One thousand treatments, between January 2010 and January 2020, with BoNTA reconstituted with lidocaine for the rejuvenation of the upper third of the face, were performed and retrospectively evaluated. (3) Results: A few seconds after the BoNTA injections, the effect of muscle paralysis was seen in all cases; this allowed providing an optimal symmetric result with no need for a touch-up procedure at the control after three weeks. A burning sensation during the injections was claimed by almost all patients. Major complications were not registered. No touch-up procedures were required. (4) Conclusions: The results of this study show how the reconstitution of BoNTA with lidocaine may avoid imperfect results after the injections; the immediate feedback on the extent of paralysis to be expected from the chemodenervation action of BoNTA allows the physician to have immediate control of the final result. [ABSTRACT FROM AUTHOR]

The aim of this study was to estimate the overall viability of the islanded facial artery myomucosal flap (iFAMM) compared to the facial artery myomucosal flap (FAMM). A systematic review of English articles was performed on PubMed and Cochrane Library electronic databases. Search terms included every nomenclature variant for FAMM flap and iFAMM flap. A total of 373 articles were identified, and 20 articles were considered eligible for inclusion in the review. A total of 486 flaps were evaluated (350 FAMM and 136 i-FAMM flaps). In all studies, the primary outcome assessed was flap viability, collecting the rate of total and partial flap necrosis and then comparing FAMM to i-FAMM. Overall reported partial/total necrosis rate for FAMM flap was 9.7%, 1.4% as total and 8.3% as partial necrosis. Overall partial/total reported necrosis rate for iFAMM flaps was 2.2%, 1.5% as total and 0.7% as partial necrosis. FAMM flaps, both as classical or islanded variants, are an effective option for intraoral small/medium sized defect reconstruction. Outcomes from the present review show a higher partial/total survival rate when this flap is harvested as islanded flap. [ABSTRACT FROM AUTHOR]

Treatment of skin unaesthetic vascular lesions is still suboptimal. In this article, we present a multicenter study evaluating the efficacy and safety of the sequential 755 nm Alexandrite and 1064 nm ND:YAG lasers for the treatment of acquired and congenital vascular lesions of the skin. A total of 171 patients were included in the study (141 female and 30 male), median age 38, skin type from I to IV. Numbers of patients categorized for treated disease: 22 spider angiomas, 67 facial telangiectasia/spider veins, 58 leg telangiectasia/reticular leg veins, 24 port wine stains (PWS). Of those lesions 30.7% was on legs, 63.7% on face (6.7% on forehead, 10.1% on temples, 21.7% on cheeks, 25.2% on nose, 1.7% on chin) and 5.6% on chest. Spider angiomas required from 1 to 3 treatments. Facial telangiectasias had been treated from 1 to 4 times. Leg telangiectasias needed from 2 to 6 treatment sessions. Regarding PWS, it takes from 6 to 9 laser treatment to reach the clearance of the lesion. All the vascular disorders treated showed marked improvement while side effects were limited to low pain sensation and transitory fenomena. This sequential treatment is an effective, safe, and new approach for unaesthetic skin vascular lesions. [ABSTRACT FROM AUTHOR]

Botulinum toxin typeA (BoNTA) is widely used in aesthetic medicine as primary treatment to reduce facial wrinkles. Major unmet needs in the field of the injection techniques include dilution factor, injected volume and site. Since 2013, an innovative protocol has been developed in our clinic that works on a double dilution volume, identifies the injection site according to the specific anatomical‐functional characteristics of each patient's musculature and applies a gentle massage to the injected area to optimize the toxin spread in the muscle. We retrospectively retrieved medical records of subjects that underwent aesthetic treatments in our outpatient Italian clinics from 2013. In cobotulinum toxin A was used in double dilution (100 AU in 5 mL of physiologic solution) and followed by a gentle massage after the injection to increase the distribution into the muscle. 197 subjects, most of them drug‐naïve (81.7%), underwent 869 BoNTA treatments. On average, higher total units and volumes were applied in first visits or older subjects whereas the lower ones were preferred in following visits or younger subjects. As perceived by the patients, the effects of BoNTA lasted more than 6 months in about 38% of the cases. 95.9% of subjects declared to be satisfied,whereas 5.2% of adverse events were observed (4.8% hematoma, 0.2% ptosis, and 0.2% tenderness). To date, we offer a BoNTA treatment with the aim to maximize the results and consequent patient's satisfaction, with low incidence of complications. [ABSTRACT FROM AUTHOR]

Featured Application: Stable silicone implant insertion and fixation using absorbable yarns potentially used for aesthetic purposes and anatomic reconstructions. In this paper, we present a simple way to place the implant into a harvested pocket and to subsequently fix it percutaneously. Eighteen patients (1 male, 13 females, 4 transgender), underwent facial implant placement; a total of 31 implants were placed (1 pair of angles of the mandible implants, 12 pairs of malar/sub-malar implants, and 5 chin implants). The intraoral approach was performed on 15 patients, and on the remaining three patients, the sub-ciliary lower lid approach was preferred. Patients were followed up for at least one year with a maximum follow-up of seven years (mean 1.8 years). In all the cases, except one, patients healed without complications. One case of implant displacement and infection was recorded. No other complication was documented. The technique described is similar to the one suggested by Peled, although some useful tips were added, namely the use of sutures, not only to fix the implant but also to drive it into the harvested pocket. In addition, larger absorbable "left in place" sutures were used, avoiding accidental implant dislocation during their removal. Further studies are required to gain a more complete understanding of the effectiveness and reproducibility of this surgical technique. [ABSTRACT FROM AUTHOR]