A 12-Month Analysis of the Dermatologic Effects and Durability of Midface Volume Correction With DEFCL Volumizing Filler in a Prospective, Single-Center Study.

BACKGROUND: Certain manufacturing processes confer distinctive rheologic features to hyaluronic acid (HA), ensuring long-lasting effects. Skin quality improvement and the volumizing effects of the DEFCL volumizer filler, a sterile, biodegradable, viscoelastic, transparent, isotonic, and homogenized injectable cross-linked high G' filler for the treatment of moderate-to-severe age-related midface changes, were initially documented at 6 months after the first injection. OBJECTIVE: The authors aimed to objectively evaluate the effects of the DEFCL volumizer filler in improving skin density, thickness, and biomechanical properties and on tissue volume augmentation in women with midface volume loss after 12 months. MATERIALS AND METHODS: Fifty women with midface volume loss were recruited in this prospective, noncomparative, single-center, postmarket study. The authors report changes in skin density, thickness, and quality and subjective and objective evaluation of facial and/or cheek volume augmentation using the Global Aesthetic Improvement Scale, as well as injection site reactions and adverse events. RESULTS: Improvements in skin quality and thickness and volumization were maintained 12 months after the first injection. Injector and patient satisfaction were highly rated with only mild adverse reactions observed. CONCLUSION: Skin improvement and volumizing effects persisted in patients treated with the DEFCL volumizer after 12 months.

Intradermal Injection of Hybrid Complexes of High- and Low-Molecular-Weight Hyaluronan: Where Do We Stand and Where Are We Headed in Regenerative Medicine?

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.

An Interim 6-Month Analysis of the Dermatologic Effects and Midface Volume Correction With XTR CL Filler in a Prospective, Single-Center Study.

BACKGROUND: Hyaluronic acid-based filler injections with parenteral anesthetics have become the standard in treating midface volume deficits. There are currently limited data on the effects of these types of fillers on skin density, thickness, and firmness. OBJECTIVE: This study aimed to assess the efficacy of XTR CL filler in improving skin quality and tissue volume in women with midface volume loss. MATERIALS AND METHODS: In this prospective, noncomparative, single-center study, 50 women aged between 40 and 60 years with midface volume loss were recruited. The primary endpoint was the improvement in investigator-assessed Global Aesthetic Improvement Scores (GAIS) 1 month after treatment. Secondary endpoints include objective measurements of skin density, thickness, and quality measurements, facial and/or cheek volume augmentation, subjective GAIS, and device evaluation from after the first injection until 6 months, and the documentation of injection site reactions and adverse events. RESULTS: XTR CL use led to significant improvement in midface volume deficits, and skin quality and skin thickness. Injector and subject satisfaction with the treatment were documented and only mild-to-moderate adverse reactions were reported. CONCLUSION: XTR CL was shown to be effective in improving volume loss and skin quality at 6 months.

Gluteal Augmentation with Hyaluronic Acid Filler: A Retrospective Analysis Using the BODY-Q Scale.

INTRODUCTION: Minimally invasive techniques, such as filler injection, are now available for posterior body contouring. However, limited data on the outcome of gluteal augmentation with hyaluronic acid (HA) are available in the literature. MATERIAL AND METHODS: We performed a retrospective analysis of 43 patients with Body Mass Index ≤ 30, and low-grade ptosis or no ptosis who underwent gluteal augmentation with HA at our clinics. Treatment response was evaluated with a patient-reported assessment scale (BODY-Q) at baseline, and after 6 months. RESULTS: Patients were satisfied with treatment as observed by a statistically significant increase in mean BODY-Q scores at 6 months (8.14 ± 2.19 vs. 14.40 ± 2.38, p < 0.0001). Such increase was more pronounced in patients who were treated with a higher number of vials (8-12 vials vs. 14-20 vials). No serious complications were observed during or after treatment. CONCLUSION: Gluteal augmentation with hyaluronic fillers is a safe, minimally invasive procedure with good aesthetic results. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

The Rheology and Physicochemical Characteristics of Hyaluronic Acid Fillers: Their Clinical Implications.

Hyaluronic acid (HA) fillers have become the most popular material for facial volume augmentation and wrinkle correction. Several filler brands are currently on the market all around the world and their features are extremely variable; for this reason, most users are unaware of their differences. The study of filler rheology has become a wellspring of knowledge, differentiating HA fillers, although these properties are not described thoroughly by the manufacturers. The authors of this review describe the more useful rheological properties that can help clinicians understand filler characteristics and the likely correlation of these features with clinical outcomes.

Injectable Non-Animal Stabilized Hyaluronic Acid as a Skin Quality Booster: An Expert Panel Consensus.

Hyaluronic acid (HA) is used extensively in aesthetic medicine thanks to its documented role in skin rejuvenation. The specific applications of HA-based products are not always fully acknowledged due to a lack of consistent recommendations. In this paper, the authors have summarized available published data on the range of applications of non-animal stabilized hyaluronic acid (NASHA®) gel skin boosters (NSBs) in several anatomical areas and types of patient, as well as their own recommendations. Overall, the panel agreed that a standard initial protocol treatment of up to 3 sessions, followed by a maintenance schedule, would allow patients to improve and then preserve skin quality over time. Indeed, distinct effects are evident after the first session, but a progressive enhancement of skin texture is detectable for up to 12 months after repeat treatment at 4 to 6 month intervals. Moreover, the authors agreed that the NASHA gel, reaching the dermis, is able to reestablish a greater degree of hydration and stimulate collagen that, in turn, restores the volume and density of the skin. Thus, a strong consensus was reached that NSB procedures are minimally invasive, safe, and effective, and designed to improve skin texture and maintain skin quality.

J Drugs Dermatol. 2018;17(1):83-88.

A CE-Marked Drug Used for Localized Adiposity Reduction: A 4-Year Experience.

BACKGROUND: Injectable fat-reducing therapies are not an alternative to liposuction. Rather, they may be best suited for patients who are unwilling or unable to undergo surgical reduction of small collections of fat, and for patients who desire touchups for liposuction-induced irregularities. OBJECTIVES: The authors report their 4-year experience with a novel injectable CE-marked drug, used in an off-label manner. METHODS: Between October 2009 and November 2013, 186 patients were treated by injection of an adipocitolytic solution in 1 of 4 private Italian aesthetic facilities, by 1 of 4 independent physicians. Treated areas included the neck, hips/saddlebags, abdomen/love handles, inner thighs, and buffalo hump. Complications and side effects were documented. RESULTS: All patients experienced mild to moderate swelling and reddening of the skin, which resolved 3 to 5 days after injection. No major complications or side effects occurred, such as necrosis. Rates of transient events were as follows: hematoma, 1.61%; paresthesia, 1.07%; and ecchymosis, 6.45%. Pruritus was reported by 21.5% of patients, which began 3 to 7 days following injection. Subcutaneous nodules were noted in 1.61% and resolved within 4 months of injection. A transitory "unusual sensation" was reported by 12.9% of patients, which lasted up to 2 months after final injection. CONCLUSIONS: Results demonstrate that this CE-marked agent appears to be effective and safe for medical treatment of fat reduction.

Profhilo® Structura, Current Status and Future Perspectives: A Practical Review.

Hyaluronic acid (HA)-based injectables continue to grow in popularity and are used worldwide to improve facial changes associated with aging. Profhilo® Structura (IBSA Farmaceutici Italia, Lodi, Italy) is a novel HA-based product that uses nano hybrid complex of hyaluronic acid (NAHYCO)® technology to create hybrid cooperative complexes consisting of high and low molecular weight HA. Profhilo® Structura's high concentration (45 mg of total HA) and rheological properties (ie, viscosity [resistance to flow] and elasticity [stickiness]) have been specially formulated to restore facial adipose tissue. Because of their early involvement in the facial aging process, the superficial medial and lateral-temporal cheek fat compartments are good candidates for treatment. However, recommendations and guidelines are necessary to ensure that treatment is safe and effective. Three experts were invited to IBSA Farmaceutici Italia Srl to discuss clinical rationale, optimal injection techniques, and clinical outcomes for treating the superficial medial and lateral-temporal cheek fat compartments with Profhilo® Structura. These techniques were developed using patients presenting with either initial hypotrophy of fat compartments within the preauricular area (ie, sinkers) or jowl sagging due to hypotrophy within the preauricular and zygomatic areas (ie, saggers). Targeting these areas using the optimal injection site can maximize product diffusion and minimize the risk for vascular compromise. Targeting these areas also leads to lateral tightening and lipolifting effects due to adipose tissue restoration. The experts agreed that Profhilo® Structura is currently the first and only HA-based injectable treatment that can integrate and restore the adipose tissue in these affected fat compartments.

Eyebrow lifting with barbed threads: A simple, safe, and effective ambulatory procedure.

INTRODUCTION: Changes in brow positioning are one of the first facial aging signs. A more beautiful and younger look can be achieved by repositioning the tissues involved in brow descent and sagging eyelids. METHODS: We report the outcome of eyebrow thread lifting in a series of patients who came to our clinic to improve their gaze. Response to treatment was assessed at 6- and 12-months using FACE-Q™ upperlids and eyebrow/forehead scales. RESULTS: A total of 38 patients with mild-to-moderate brow ptosis or without ptosis underwent eyebrow thread lifting (mean age 35.5, all female). No serious complications were observed during or after treatment. All patients were satisfied with the outcome of the intervention. Mean FACE-Q™ scores improved at six months compared with baseline. A statistically significant increase in mean FACE-Q™ scores was still seen at 12 months and was more evident in younger women. Patients were able to go back to their daily lives the day after the procedure. CONCLUSION: Eyebrow thread lifting is a minimally invasive procedure able to overcome mild-to-moderate ptosis with excellent aesthetic results. In the absence of ptosis, thread lifting is a good choice to reposition the brow and improve the gaze. The technique is simple to perform and safe.

Guided Superficial Enhanced Fluid Fat Injection (SEFFI) Procedures for Facial Rejuvenation: An Italian Multicenter Retrospective Case Report.

BACKGROUND: The aging process starts in the center of the face, in the periocular region and around the mouth, with a combination of volume loss, tissue descent, deepened wrinkles, and the loss of skin structure and quality. Recently, several studies have demonstrated the efficacy of therapies based on autologous adipose tissue grafting, which leverages the properties of stromal vascular fraction (SVF) and adipose-derived mesenchymal stem cells (ADSCs) to accelerate the regenerative processes of the skin. This study aims to verify the ability of guided superficial enhanced fluid fat injection (SEFFI) in the facial area to correct volume loss and skin aging, proving that this standardized procedure has a very low rate of complications. METHODS: We retrospectively collected data from 2365 procedures performed in Italian centers between 2019 and 2021. Guided SEFFI was performed alone or combined with cosmetic treatments, including the use of hyaluronic acid filler, suspension threads, synthetic calcium hydroxylapatite, botulin toxin, and microneedling. RESULTS: guided SEFFI was used alone in more than 60% of the patients and in all facial areas. In about one-tenth of the patients, guided SEFFI was combined with a botulin toxin treatment or hyaluronic acid filling. Other procedures were used more rarely. Ecchymosis in the donor or injection sites was the most frequent adverse event but was only observed in 14.2% and 38.6% of the patients, respectively. CONCLUSIONS: The guided SEFFI technique is standardized and minimally invasive, leading to very few complications. It constitutes a promising antiaging medical treatment that combines effectiveness, safety, and simplicity.

Expert Consensus on Soft-tissue Repositioning Using Absorbable Barbed Suspension Double-needle Threads in Asian and Caucasian Patients.

Bioabsorbable barbed suspension double-needle threads have recently been thrust into the limelight as a minimally invasive alternative for skin repositioning. When compared to surgical face lifting, use of these threads requires reduced procedural and recovery time, no general anesthesia, confers immediate patient satisfaction, with no cutaneous incisions and no apparent scars, and is more tolerable. There is currently limited literature providing clinical guidance on the use of these suspension threads; hence, this consensus document was developed as the first publication to discuss the technical aspects of facial rejuvenation using the double-needle barbed bioabsorbable and hydrolyzable thread composed of copolymer poly (ε-caprolactone-co-L-lactic acid) or PCxLyA, that is, Definisse threads. The Board of Aesthetic Leaders and Investigators (BALI) is a panel of dermatologic surgery and plastic surgery experts who convened last July 2018 in Indonesia to discuss the aforementioned challenges. A thorough literature search was done where a review of specific technical recommendations based on prevailing practice and available guidelines pertaining to suspension threads were described and are summarized in this paper. A detailed list of pretreatment recommendations in the assessment of both Asian and Caucasian facial types, aging facial types, guidance on insertion techniques, and aftercare instructions for clinicians to review has been included here.

A Review on the Combined Use of Soft Tissue Filler, Suspension Threads, and Botulinum Toxin for Facial Rejuvenation.

The aim of combining different minimally invasive techniques is to achieve the most harmonious and most natural-looking facial rejuvenation as effectively and as safely as possible. Due to their safety and versatility, botulinum toxin and soft tissue fillers have become the most sought-after modalities for correcting the signs of facial aging. Recently, bioabsorbable threads used for repositioning ptotic facial tissue have been added into the picture. More practitioners are also combining threads with fillers and botulinum toxin to achieve longer-lasting and natural-looking results. Our aim is to provide guidance on basic anatomical landmarks and areas where botulinum toxin injections, subcutaneous filler injections, and bioabsorbable suspension threads are placed on the face. We would also like to share our best practices on the best combination, spacing the appropriate time intervals in between each procedure to allow for the shortest possible recovery time, as well as periprocedural advice for an integrated treatment approach.

Development and Validation of IBSA Photographic Scale for the Assessment of Inner Upper Arm Laxity.

OBJECTIVE: To describe the development and validation of the 5-grade photographic IBSA inner upper arm scale. METHODS: From 2 real-life pictures, a scale made up of 5 morphed images showing increasing severity of inner upper arm laxity was created. For validation, a set of 50 images (half of which real and the other morphed) was developed and sent to 5 trained physicians in two rounds 30 days apart. Raters' task was to make a selection of each image according to the given scale. Inter-rater and intra-rater reliability were evaluated in both rounds. RESULTS: As to intra-rater reliability, single-rater kappa scores between 0.74 and 1.00 and a global kappa score of 0.846 were observed, while inter-rater agreement was calculated with intra-class correlation coefficient reporting scores higher than 0.91, which indicate excellent reliability. CONCLUSION: IBSA inner upper arm laxity scale proved to be a validated and reliable tool.

Evaluation of the Rheologic and Physicochemical Properties of a Novel Hyaluronic Acid Filler Range with eXcellent Three-Dimensional Reticulation (XTR™) Technology.

Soft-tissue fillers made of hyaluronic acid and combined with lidocaine have recently become a popular tool in aesthetic medicine. Several manufacturers have developed their own proprietary formulae with varying manufacturing tools, concentrations, crosslinked three-dimensional network structures, pore size distributions of the fibrous networks, as well as cohesivity levels and rheological properties, lending fillers and filler ranges their unique properties and degradability profiles. One such range of hyaluronic acid fillers manufactured using the novel eXcellent three-dimensional reticulation (XTR™) technology was evaluated in comparison with other HA fillers and filler ranges by an independent research laboratory. Fillers manufactured with the XTR™ technology were shown to have characteristic rheological, crosslinking and biophysical factors that support the suitability of this filler range for certain patient profiles.

Advanced botulinum toxin techniques against wrinkles in the upper face.

The use of botulinum toxin type A for facial rejuvenation is one of the most common procedure in esthetic medicine. Overall clinical and study experience with botulinum toxin type A for facial enhancement has confirmed that it is effective and safe even in the long term. The different injection techniques, the starting doses, the sex, the dilution, and the storing of the product, nevertheless, may influence the final result of the treatment. In this article we propose some recommendations including general principles as well as information about its specific use. Perhaps one of the most important perspectives is that, based on a well-established knowledge of the technique, individualized esthetic planning is the key to success. This depends on a precise understanding of the underlying anatomy and physiology of the individual muscles and their interactions, as well as on individual patient's characteristics, including goals and expectations.

Phosphatidylcholine and sodium deoxycholate in the treatment of localized fat: a double-blind, randomized study.

BACKGROUND: Recent articles have introduced the novel concept of chemical lipolysis through local injections. Phosphatidylcholine is the active drug in the commercial preparation used for this purpose, but some studies have suggested that sodium deoxycholate, an excipient of the preparation, could be the real active substance. AIM: We decided to investigate whether phosphatidylcholine and sodium deoxycholate have any clinical efficacy in chemical lipolysis and their respective roles. We also studied the safety and side effects of the treatments. MATERIALS AND METHODS: Thirty-seven consecutive female patients were studied for the treatment of localized fat in gynoid lipodystrophy. Each patient received injections of a phosphatidylcholine/sodium deoxycholate preparation on one side and sodium deoxycholate on the contralateral side, each single patient being herself the control. Four treatments were carried out every 8 weeks in a double-blind, randomized fashion. Metric circumferential evaluations and photographic and ultrasonographic measurements throughout the study allowed for final judgment. A statistical evaluation concluded our study. RESULTS: An overall reduction of local fat was obtained in 91.9% of the patients without statistically significant differences between the treated sides. Reduction values on the phosphatidylcholine/sodium deoxycholate-treated sides are in the order of 6.46% metrically and 36.87% ultrasonographically, whereas on the deoxycholate-treated sides they are in the order of 6.77% metrically and 36.06% ultrasonographically. Both treatments, at the dose used in the study, proved safe in the short term. The most common side effects were local and few, but were more pronounced on the deoxycholate-treated sides. No laboratory test was carried out. CONCLUSION: Both treatments have shown moderate and equivalent efficacy in treating localized fat, with sodium deoxycholate having a slower postoperative resolution, suggesting that sodium deoxycholate could be sufficient by itself to determine fat cell destruction and that phosphatidylcholine could be useful for obtaining a later emulsification of the fat.

Safety and Early Satisfaction Assessment of Patients Seeking Nonsurgical Rhinoplasty with Filler.

BACKGROUND: Nonsurgical aesthetic treatments are usually preferred by patients because their effects are visible immediately after the treatment and patients can return to their normal activities on the same day. Although many studies have indicated safety and efficacy of filler injection to improve facial appearance, it is not absolutely confirmed for nose reshaping. OBJECTIVES: To assess the safety and early satisfaction of 52 consecutive patients underwent nonsurgical rhinoplasty with an injection of a 20-mg/mL smooth, cohesive, and viscous hyaluronic acid (HA) filler. MATERIALS AND METHODS: Fifty-two consecutive healthy patients, dissatisfied with the appearance of their nose, were treated with HA injections between November 2014 and November 2016. Complications and side effects were documented. Aesthetic outcomes were scored subjectively on a scale of 1-4 represented by four emoticons. RESULTS: Among patients, 96.15% affirmed to be "very satisfied" at the end of the procedure (50 patients over 52 treated). No major complications and side effects occurred. CONCLUSIONS: Outcomes of this study, with the limitation of a non-comparative open-label study, show that surgical remodeling of the nose, with the use of a 20-mg/mL smooth, cohesive, and viscous HA filler, is a safe and predictable technique, with a high degree of satisfaction for the patients.

Facial Rejuvenation with Fillers: The Dual Plane Technique.

BACKGROUND: Facial aging is characterized by skin changes, sagging and volume loss. Volume is frequently addressed with reabsorbable fillers like hyaluronic acid gels. MATERIALS AND METHODS: From an anatomical point of view, the deep and superficial fat compartments evolve differently with aging in a rather predictable manner. Volume can therefore be restored following a technique based on restoring first the deep volumes and there after the superficial volumes. We called this strategy "dual plane". A series of 147 consecutive patients have been treated with fillers using the dual plane technique in the last five years. RESULTS: An average of 4.25 session per patient has been carried out for a total of 625 treatment sessions. The average total amount of products used has been 12 ml per patient with an average amount per session of 3.75 ml. We had few and limited adverse events with this technique. CONCLUSION: The dual plane technique is an injection technique based on anatomical logics. Different types of products can be used according to the plane of injection and their rheology in order to obtain a natural result and few side effects.