Efficacy and Safety of Neauvia Intense in Correcting Moderate-to-Severe Nasolabial Folds: A Post-Market, Prospective, Open-Label, Single-Centre Study.

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.

Melasma and reflectance confocal microscopy: from baseline to treatment monitoring.

Melasma is a frequent condition worldwide, and it represents one of the most challenging disorders to treat in cosmetic dermatology. One of the critical factors for treatment prognosis is the assessment of the depth and distribution of pigment within the hyperpigmented area. Nowadays, non-invasive skin imaging techniques, such as reflectance confocal microscopy (RCM), have been used to estimate pigment distribution and depth within different skin layers. This article aims to provide a systematic review of RCM applications in melasma, providing terminology and investigating characteristics of melasma at baseline and after medical and laser treatment. Our results support the recognition of two main types of melasma, epidermal and mixed type, thanks to the role of RCM in highlighting the precise pigment depth location in the skin non-invasively. RCM treatment monitoring enables the objectification of pigment variations after treatment and the identification of prognostic factors for different treatment modalities. After the era of the application of RCM as a technique applied strictly to skin cancers, additional cosmetic applications are emerging, such as the application of melasma treatment monitoring.

Melanocortin-1 receptor (MC1R): a review for dermatologists.

Melanocortin-1 receptor (MC1R) and its variants have a pivotal role in melanin synthesis. However, MC1R has been associated to non-pigmentary pathways related to DNA-repair activities and inflammation. The aim of this review is to provide an up-to-date overview about the role of MC1R in the skin. Specifically, after summarizing the current knowledge about MC1R structure and polymorphisms, we report data concerning the correlation between MC1R, phenotypic traits, skin aging, other diseases and skin cancers and their risk assessment through genetic testing.

Blaschkoid melanotic cutaneous lupus erythematosus with "melanocytic nests".

Melanotic cutaneous lupus erythematosus (LE) is a newly described clinical variant of chronic cutaneous LE, presenting with localized or diffuse brownish or grayish macular and reticulated pigmentation in the absence of erythema, scaling, atrophy, scarring, or telangiectasia. The diagnosis is based upon histopathology, which demonstrates the characteristic features of LE with an interface vacuolar dermatitis with melanophages, and a superficial and deep, perivascular and periadnexal lymphocytic infiltrate with mucin deposition. Herein, we describe a case of a 61-year-old White male presenting with melanotic cutaneous LE with a blaschkoid distribution on his face in which the histopathological phenomenon of "true melanocytic nests" in the setting of a lichenoid pattern was seen. We want to highlight how nests of cellular aggregates at the dermoepidermal junction labeling with melanocytic markers may occur in the setting of an interface tissue reaction. This benign reactional pattern may mimic atypical melanocytic proliferations, especially on sun-damaged skin. Clinicopathological correlation and careful microscopic examination using a panel of multiple melanocytic markers is crucial for making an accurate final diagnosis. All the cases of melanotic cutaneous LE reported in the literature are also reviewed.

Lichen Planus Pigmentosus with True Melanocytic Nests: A Case Report with a Comprehensive Literature Review.

Lichen Planus Pigmentosus (LPP) is an uncommon variant of lichen planus characterized by the development of dark greyish-brown macules and patches primarily affecting sun-exposed areas. Histologically, it presents with lichenoid interface dermatitis with many melanophages. In select cases, the presence of melanocytic nests or pseudomelanocytic nests within LPP lesions has been documented, posing a diagnostic challenge. We present a detailed case report of a 32-year-old Eritrean woman with a longstanding history of hyperpigmented macules, alongside an in-depth review of the existing literature on lichenoid dermatoses featuring melanocytic or pseudomelanocytic nests. This paper delves into the clinical presentation, histopathological features, differential diagnosis, and potential mechanisms underlying this intriguing phenomenon.

Efficacy of Pegylated Hyaluronic Acid Filler Enriched with Calcium Hydroxyapatite: A 24-Week Post-Market, Observational, Prospective, Open-Label, Single-Center Study.

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.

Evaluation of the Safety of Neauvia Stimulate Injectable Product in Patients with Autoimmune Thyroid Diseases Based on Histopathological Examinations and Retrospective Analysis of Medical Records.

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.

Investigation on the Biological Safety and Activity of a Gluconolactone-Based Lotion for Dermocosmetic Application.

(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-ßgal-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.

Widespread and Long-Enduring Hyperkeratosis Lenticularis Perstans (Flegel's Disease): Clinico-Pathological and Dermoscopic Features of a Rare Presentation.

Hyperkeratosis lenticularis perstans, also known as Flegel's disease (FD), is a rare cutaneous disorder affecting mainly the lower extremities of middle-aged people. Due to its rarity, this disease is usually not recognized by physicians resulting in a delay in diagnosis, especially in those cases with atypical cutaneous involvement. Herein, we present a 72-year-old woman who developed FD characterized by a generalized distribution, involving, in addition to the lower limbs, the trunk and the upper limbs as well. We performed a description of the dermoscopic and pathologic features of this rare entity, also carrying out a brief reappraisal of the cases of FD with a diffuse, atypical and generalized distribution that have been described in the literature. Histopathology with clinical correlation is the cornerstone of the diagnosis, even and especially in atypical cases. This patient with a disease duration of 58 years also represents the longest-lasting case of FD reported in the literature.

Hyaluronic Acid and Radiofrequency in Patients with Urogenital Atrophy and Vaginal Laxity.

Vaginal laxity (VL) and genitourinary syndrome of menopause (GSM), as well as aesthetic changes in the vulvar skin, often occur together and cause physical, psychological, and functional problems for women and their partners. The current study evaluated the efficacy of a nonsurgical radiofrequency device (RF) procedure combined with hyaluronic acid (HA) injection into the skin of the labia majora on clinical, histological, and aesthetic levels. Twenty women with GSM and VL, aged between 36 and 72 (mean age 53.4), were treated with bipolar RF SECTUM, vaginal and vulvar application, as well as with a hyaluronic acid (HA) injection into the skin of the labia majora. The Vaginal Laxity Questionnaire (VLQ), Vaginal Health Index (VHI), and Female Sexual Function Index (FSFI) were used to examine the clinical effects of the operations. The Global Aesthetic Improvement Scale was utilized to measure patient satisfaction. On a histochemical level, the concentrations of elastin and collagen in the vaginal wall and vulvar skin were examined. Results: There was significantly higher patient satisfaction and a considerable clinical improvement across all areas of analysis. On the histochemical level, elastin and collagen fiber concentration increased after the treatment protocol both in the vulvar skin and in the vaginal wall: elastin in the vaginal wall, 11.4%, and in the vulvar skin, 61%; collagen in the vaginal wall, 26%, and in the vulvar skin, 27%. The current study demonstrated the efficacy and safety of this nonsurgical RF procedure combined with a hyaluronic acid (HA) injection into the skin of the labia majora on clinical, histochemical, and aesthetic levels.

HA PEGylated Filler in Association with an Infrared Energy Device for the Treatment of Facial Skin Aging: 150 Day Follow-Up Data Report.

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.

The key role of levator ani thickness for early urinary continence recovery in patients undergoing robot-assisted radical prostatectomy: A multi-institutional study.

BACKGROUND: Urinary continence (UC) recovery dramatically affects quality of life after robot-assisted radical prostatectomy (RARP). Membranous urethral length (MUL) has been the most studied anatomical variable associated with UC recovery. OBJECTIVE: To investigate whether levator ani thickness (LAT), assessed with multi-parametric magnetic resonance imaging (mpMRI), correlates with UC recovery after RARP. DESIGN, SETTING, AND PARTICIPANTS: The study included 209 patients treated with RARP by expert surgeons with extensive robotic experience from 2017 to 2019. All patients had complete, clinical, mpMRI, pathological, and postoperative data including pelvic floor muscle training (PFMT) protocols. INTERVENTION: After a radiologist-specific training, two urologists independently examined the files, blinded to clinical and pathological findings as well as to postoperative continence status. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: On mpMRI, LAT, bladder neck (BN) shape, MUL, and apex overlapping (AO) were measured. UC recovery was defined as use of 0 or 1 safety pad at follow-up. Multivariable models were used to assess the association between variables and UC recovery. RESULTS AND LIMITATIONS: Overall, 173 (82.8%) patients were continent after a median follow-up of 23 months (interquartile range [IQR]: 17-28). Of these, 98 (46.9%) recovered within 3 months after surgery, 42 (20.1%) from 3 to 6 months, and 33 (15.8%) from 6 months onwards. A significant higher rate of patients with LAT > 10 mm (88.1 vs.75.8%; p = 0.03) experienced UC recovery, compared to those with LAT < 10 mm. This difference was observed in the first 3 months after surgery. At multivariable analysis, LAT (odds ratio [OR]: 1.18, 95% confidence interval [CI]: 1.02-1.37; p = 0.02), Preoperative ICIQ score (OR: 0.91, 95% CI: 0.82-0.98, p = 0.03) and PFMT (OR: 1.98, 95% CI: 1.01-3.93; p = 0.04) independently predict higher UC recovery within 3 months, after accounting for age, BMI, preoperative PSA, D'Amico risk group, MUL, BN shape and AO. CONCLUSIONS: LAT greater than 1 cm was associated with greater UC recovery. Specifically, LAT greater than 1 cm seems to be associated with higher UC rate at 3 months after RARP, compared to those with LAT < 1 cm. PATIENT SUMMARY: Magnetic resonance features can help in predicting the risk of incontinence after robot-assisted radical prostatectomy and should be taken into account when counseling patients before surgery.