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In this study, microscopic, histochemical and ultrastructural observations in human skin are presented, 8 months after an injection of a novel PEGylated filler. Morphological features demonstrated an excellent integration of the filler with the connective tissue components and an effective interpenetration with the ground substance. The filler appears uniformly distributed inside the hypodermis. No segregation or encapsulation of cells and other structures was observed nor evidence of immunological adverse reaction. Furthermore, observed ultrastructural modifications of fibroblasts supports a stimulatory effect of molecular components production of the extracellular matrix, contributing to the cutaneous connective tissue renewal. In this study, microscopic, histochemical and ultrastructural observations in human skin are presented, 8 months after an injection of a novel PEGylated filler. Morphological features demonstrated an excellent integration of the filler with the connective tissue components and an effective interpenetration with the ground substance. The filler appears uniformly distributed inside the hypodermis. No segregation or encapsulation of cells and other structures was observed nor evidence of immunological adverse reaction. Furthermore, observed ultrastructural modifications of fibroblasts supports a stimulatory effect of molecular components production of the extracellular matrix, contributing to the cutaneous connective tissue renewal.

To alert patients and health care providers about the use of energy-based devices to perform a vaginal “rejuvenation,” cosmetic vaginal procedures, or nonsurgical vaginal procedures to treat symptoms related to menopause, urinary incontinence, or sexual function, the US Food and Drug Administration (FDA) has issued a warning about the effectiveness and safety of such devices. We agree with the FDA that certain devices (laser, radiofrequency, etc.) have been marketed inappropriately for uses that are outside of their cleared or approved intended uses. We want to position ourselves in the strict training of professionals so that the indications and techniques are used in the best possible way, knowing that, similar to any medical or surgical technique, the side effects can appear in the short and long term, and should be recognized and remedied. © 2019, Springer-Verlag London Ltd., part of Springer Nature.

Neauvia Stimulate® is a biocompatible, injectable hyaluronic acid (HA) filler (26 mg/ml) PEG crosslinked with 1% of calcium hydroxyapatite (CaHA) for facial soft-Tissue augmentation that provides volume to tissues, followed by a process of neocollagenesis for improving skin quality. The aim of the present study is to evaluate the possible modulation of collagen synthesis after treating human fibroblasts cultured in vitro with the product (Lot. 160517-26-1/2 PEG). The experimental model proposed, despite being an in vitro system, allows the derivation of useful information to predict the possible activity of the product in further in vivo application. Human fibroblasts (PEU cells) were treated with the product for 24 h at increasing concentrations of compared to control (untreated cells). The modulation of collagen synthesis was evaluated using a specific colorimetric kit (Sircol, Soluble Collagen Assay Kit). Increment of collagen production, 37.62% and 97.39% at concentrations of 1.25 mg/ml and 2.5 mg/ml of product, respectively, was considered to be statistically significant (∗p values ≤0.05 and ∗∗p values ≤0.01) when compared with control (untreated cells). In conclusion, Hyaluronic Acid Hydrogel 26 mg/ml PEG cross-linked with calcium hydroxyapatite in low concentrations (1%) determines a statistical increment in neocollagenesis. Neauvia Stimulate® is a biocompatible, injectable hyaluronic acid (HA) filler (26 mg/ml) PEG crosslinked with 1% of calcium hydroxyapatite (CaHA) for facial soft-Tissue augmentation that provides volume to tissues, followed by a process of neocollagenesis for improving skin quality. The aim of the present study is to evaluate the possible modulation of collagen synthesis after treating human fibroblasts cultured in vitro with the product (Lot. 160517-26-1/2 PEG). The experimental model proposed, despite being an in vitro system, allows the derivation of useful information to predict the possible activity of the product in further in vivo application. Human fibroblasts (PEU cells) were treated with the product for 24 h at increasing concentrations of compared to control (untreated cells). The modulation of collagen synthesis was evaluated using a specific colorimetric kit (Sircol, Soluble Collagen Assay Kit). Increment of collagen production, 37.62% and 97.39% at concentrations of 1.25 mg/ml and 2.5 mg/ml of product, respectively, was considered to be statistically significant (∗p values ≤0.05 and ∗∗p values ≤0.01) when compared with control (untreated cells). In conclusion, Hyaluronic Acid Hydrogel 26 mg/ml PEG cross-linked with calcium hydroxyapatite in low concentrations (1%) determines a statistical increment in neocollagenesis.

Objective Microablative fractional CO2 laser has been proven to determine tissue remodeling with neoformation of collagen and elastic fibers on atrophic skin. The aim of our study is to evaluate the effects of microablative fractional CO2 laser on postmenopausal women with vulvovaginal atrophy using an ex vivo model. Methods This is a prospective ex vivo cohort trial. Consecutive postmenopausal women with vulvovaginal atrophy managed with pelvic organ prolapse surgical operation were enrolled. After fascial plication, the redundant vaginal edge on one side was treated with CO2 laser (SmartXide2; DEKA Laser, Florence, Italy). Five different CO2 laser setup protocols were tested. The contralateral part of the vaginal wall was always used as control. Excessive vagina was trimmed and sent for histological evaluation to compare treated and nontreated tissues. Microscopic and ultrastructural aspects of the collagenic and elastic components of the matrix were studied, and a specific image analysis with computerized morphometry was performed. We also considered the fine cytological aspects of connective tissue proper cells, particularly fibroblasts. Results During the study period, five women were enrolled, and 10 vaginal specimens were finally retrieved. Four different settings of CO2 laser were compared. Protocols were tested twice each to confirm histological findings. Treatment protocols were compared according to histological findings, particularly in maximal depth and connective changes achieved. All procedures were uneventful for participants. Conclusions This study shows that microablative fractional CO2 laser can produce a remodeling of vaginal connective tissue without causing damage to surrounding tissue. © 2015 by The North American Menopause Society.

Nonsurgical cosmetic facial procedures have gained popularity in recent decades. These procedures are commonly referred to as facial rejuvenation, and only a few are performed in the neck region. Herein, the authors describe their experience with off-label use of deoxycholic acid (DC) injections on 18 patients for remodeling of the neck and lower jaw. The injection protocol was personalized for each patient, and lidocaine was always premixed with the DC. After the initial injection visit, at least 3 months passed before further injections were considered. All documented side effects, including swelling and dysesthesia, resolved spontaneously. All patients received follow-up for at least 3 months, and only 2 patients required a second session of injections. By personalizing the injection protocol for each patient, good outcomes were achieved, including aesthetic enhancement of the shape and contour of the jaw and neck. Although the study is limited by the relatively small sample size, the results are promising and warrant additional investigations. Nonsurgical cosmetic facial procedures have gained popularity in recent decades. These procedures are commonly referred to as facial rejuvenation, and only a few are performed in the neck region. Herein, the authors describe their experience with off-label use of deoxycholic acid (DC) injections on 18 patients for remodeling of the neck and lower jaw. The injection protocol was personalized for each patient, and lidocaine was always premixed with the DC. After the initial injection visit, at least 3 months passed before further injections were considered. All documented side effects, including swelling and dysesthesia, resolved spontaneously. All patients received follow-up for at least 3 months, and only 2 patients required a second session of injections. By personalizing the injection protocol for each patient, good outcomes were achieved, including aesthetic enhancement of the shape and contour of the jaw and neck. Although the study is limited by the relatively small sample size, the results are promising and warrant additional investigations.

Aesthetic surgery of female external genitalia has gained increasing popularity over the past decade, with reduction of the labia minora (labiaplasty) being the procedure most commonly requested and performed. Female external genitalia lose elasticity and volume with age, but few studies describe the techniques for labia majora augmentation. Currently, very few studies have investigated the effectiveness and safety of labia majora augmentation with hyaluronic acid (HA) injection. This study aims to evaluate the effectiveness and safety of labia majora augmentation with hyaluronic acid filler injection. We retrospectively analyzed 37 patients affected by hypotrophy of the labia majora, treated with HA dermal filler 28mg/ml PEG crosslinked (Neauvia® Intense Rose, Matex Lab, Switzerland) between May 2015 and July 2016. Global evaluation of the aesthetics of the intimate area and clinical data were investigated with VAS (Visual Analogic Scale) ad hoc. Adverse events and complications were recorded. A total of 37 women affected by labia majora hypotrophy were treated with 28mg/ml HA dermal filler. A significant clinical improvement was observed in the score provided by both patients and doctor. Only mild adverse events and complications were recorded. HA hydrogel with a novel crosslinking agent is able to provide a considerable rejuvenation with a simple outpatient procedure and to bring a significant clinical improvement. HA-based filler infiltration treatment in labia majora is repeatable, has virtually no complications, and is reversible. Aesthetic surgery of female external genitalia has gained increasing popularity over the past decade, with reduction of the labia minora (labiaplasty) being the procedure most commonly requested and performed. Female external genitalia lose elasticity and volume with age, but few studies describe the techniques for labia majora augmentation. Currently, very few studies have investigated the effectiveness and safety of labia majora augmentation with hyaluronic acid (HA) injection. This study aims to evaluate the effectiveness and safety of labia majora augmentation with hyaluronic acid filler injection. We retrospectively analyzed 37 patients affected by hypotrophy of the labia majora, treated with HA dermal filler 28mg/ml PEG crosslinked (Neauvia® Intense Rose, Matex Lab, Switzerland) between May 2015 and July 2016. Global evaluation of the aesthetics of the intimate area and clinical data were investigated with VAS (Visual Analogic Scale) ad hoc. Adverse events and complications were recorded. A total of 37 women affected by labia majora hypotrophy were treated with 28mg/ml HA dermal filler. A significant clinical improvement was observed in the score provided by both patients and doctor. Only mild adverse events and complications were recorded. HA hydrogel with a novel crosslinking agent is able to provide a considerable rejuvenation with a simple outpatient procedure and to bring a significant clinical improvement. HA-based filler infiltration treatment in labia majora is repeatable, has virtually no complications, and is reversible.

The aim of the present study was to test the possible effects of a novel sturgeon-derived compound (LD-1227) on inflammatory markers related to metabolic nuclear receptors in patients with metabolic syndrome. The study population consisted of 76 patients with metabolic syndrome and 30 healthy subjects who were maintained to their current treatments and randomly supplemented: A) LD-1227 (n=38) or B) placebo (n=38) as compared to C) healthy controls (n=30). LD-1227 or placebo (water-soluble starch) were given daily at breakfast and dinner for three months. Levels of hs-CRP, IL-6, TNF-α, leptin and adiponectin/ resistin index were assayed at the entry, 1 month and 3 months afterwards. At the end of the study period, as compared to B group, LD-1227-treated patients showed a significant improvement of all parameters tested, irrespective of the presence of diabetes. In particular, levels of adiponectin and adiponectin/ resistin index significantly increased following LD-1227 administration. Although the metabolic syndrome remains a multifaceted condition requiring a complex approach, LD-1227 could be a potential safe therapeutic tool to be integrated into a wider treatment and preventive medicine schedule strategy.

An overview on different laser devices, available for the treatment of the different phases of wound healing: debridement, wound repair and scars correction.

The purpose of this study was to assess the effect of Celergen, a marine nutraceutical, against tumor cell invasion in human pancreatic cancer cell line (PSN-I). High invasive clone (HI) and low invasive clone (LI) were established from wild type PSN-l cell line after a repeated invasion assay test. The invasive ability of HI cells and the level of IL-6 in the conditioned medium of HI cells was significantly higher than that one of LI cells but both these parameters were significantly reduced by the addition of Celergen (p0.01). Exogenous IL-6 administration induced a dose dependent enhancement of invasive ability in both cell populations. Moreover, IL-6 receptor expression was detected in 72% of HI cells whereas this occurred only in 37% of LI cells. When co-cultured with Celergen this parameter was significantly downregulated in both cellular subsets (p0.05). The addition of conditioned medium derived from HI cells (HCM) and LI cells(LCM) enhanced the invasive ability in both cell populations without affecting cell proliferation. The effect of HCM on the invasive ability of HI cells was partially inhibited by the addition of Celergen (p0.01). In summary, overexpression of IL-6 and its receptor may be one relevant factor contributing to the highly invasive characteristic of the pancreatic cancer cell line we used while a significantly beneficial modulation was obtained by applying this novel marine nutraceutical. This advices to further explore the possibility of marine compounds regulation of IL-6 ligand/receptor and other possible invasive factor interaction in the therapy of this malignancy while further studies are awaited in this setting.

Osteoarthritis (OA) is a slow, chronic joint disease characterized by focal degeneration of articular cartilage and alterations of the chemical and mechanical articular function and also major cause of pain and physical disability. There is clinical evidence that increasing dietary n-3 relative to n-6 may be beneficial in terms of symptom management in humans but not all studies conclude that dietary n-3 PUFA supplementation is of benefit, in the treatment of OA. Our recent studies highlight the effect of a biomarine compound (LD-1227) on MMPs, collagen metabolism and on chondrocyte inflammatory markers. Thus, the aim of the present work was to test such bioactive compound versus a common nutraceutical intervention (glucosamine/chrondroitin sulfate) in knee osteoarthritis patients. The patients population consisted of 60 subjects with a recent diagnosis of knee osteoarthririts of mild-moderate severity. Patients were randomized in a double-blind study comparing LD-1227 (group A) versus a mixture of glucosamine (500 mg), chondroitin sulfate (400 mg) (group B). Patients were allowed their established painkillers on demand. At 4, 9 and 18 weeks patients were evaluated as for: VAS score assessing pain at rest, and during physical exercise, Lequesne index, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scale and KOOS scale. Moreover, serum concentrations of IL-6, IL-β, CRP, TNF-sR1 and TNF-sR2 were assessed. As compared to GC treatment, LD-1227 yielded a quicker and higher degree of improvement of the whole clinical indexes and a lower NSAIDs use at the end of the study. LD-1227 brought about also a more significant downregulation of the tested cytokines cascade. Taken overall, these data suggest that LD-1227 has the potential to be included in the nutraceutical armamentarium in the management of OA.

(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.