A Retrospective Analysis of Safety in Participants Treated with a Hybrid Hyaluronic Acid and Calcium Hydroxyapatite Filler.

Background: Limited long-term safety data are published on HA/CaHA/L, a hybrid dermal filler combining hyaluronic acid (HA), calcium hydroxyapatite (CaHA), and lidocaine (L). Methods: This retrospective multicenter study assessed treatment-emergent adverse events (TEAEs) in adults treated with HA/CaHA/L. The full analysis set (FAS) included eligible consented adults (N = 403); the long-term safety analysis (LTSA) set included FAS participants with greater than or equal to 12-months HA/CaHA/L exposure (n = 243). Results: Participants were majority female (94.0%), with Fitzpatrick skin phototypes II/III (80.1%) and a mean age of 50.1 years. Most participants (86.4%) received one HA/CaHA/L treatment. The median time between participants' first HA/CaHA/L treatment and chart review was 15.4 months. Participants received a mean of 2.2 mL (0.5-8.9 mL) filler per treatment. Treated areas were predominantly malar (71.2%) and mandible (69.7%) regions. Most participants (95.0%) had one or more aesthetic treatments other than HA/CaHA/L [eg, other dermal fillers (84.1%), botulinum toxin (63.3%)]. Nineteen (4.7%) FAS participants had 20 documented TEAEs; most (3.5%, n = 14 participants) were mild in severity. Twelve TEAEs in 11 participants (2.7%) were related to HA/CaHA/L: induration (three, 0.7%), edema (3, 0.7%), and implant site nodules (five, 1.2%), which were noninflammatory and likely related to product placement. Among the LTSA, 15 (6.2%) participants had 16 documented TEAEs (six edema, five implant site nodules, one inflammation, three skin induration, one hypersensitivity); most were mild in severity. Nine TEAEs in eight participants (3.3%) were HA/CaHA/L-related. No treatment-emergent serious AEs were reported. Conclusion: The data from this noninterventional retrospective study support the favorable longer term (>12 month) safety profile of HA/CaHA/L.

A Novel Hyaluronic Acid Filling Technique for Restoring Volume of the Labia Majora.

Vulvar rejuvenation, which includes both functional and aesthetic aspects, has received a lot of attention in recent years. Despite the fact that surgical interventions have proven to be effective, the development of minimally invasive techniques for restoring volume and tissue function remains a top priority. This case study describes a novel method for vulvar volumization and collagen stimulation of the labia majora using a hyaluronic acid filling technique. The procedure begins with a meticulous assessment of each patient's anatomical characteristics and specific concerns, followed by hyaluronic acid retroinjections using a microcannula. The current article describes the use of this technique on a single patient and emphasizes its potential benefits in addressing various vulvar concerns, with a focus on minimal downtime and high patient satisfaction. The case report adds to the ongoing search for optimal vulvar rejuvenation strategies by providing valuable insights into the efficacy and utility of this novel approach.

Facial rejuvenation with the new hybrid filler HArmonyCa™: Clinical and aesthetic outcomes assessed by 2D and 3D photographs, ultrasound, and elastography.

OBJECTIVE: Facial aging is a complex process that involves genetic, biological, and environmental factors. This paper aimed to present the first aesthetic and safety outcomes of a hybrid filler that combines hyaluronic acid (HA) (20 mg/mL) and calcium hydroxyapatite (HA/CaHa). METHODS: Prospective and non-randomized interventional study conducted on consecutive healthy patients who attended the clinic for an aesthetic facial rejuvenation procedure. HA/CaHa was injected with 23G cannula (retrograde threads, 1.25 mL per side) in the preauricular region. Ultrasound examinations, elastography images, and 2D and 3D photographs were performed before and after treatment. The primary endpoint were the volumetric changes at Day 180. RESULTS: Fifteen patients were included in the study. At Day 180 after treatment, median (interquartile-range) volume increased by 2.1 (1.9-2.3) cc and 2.1 (1.8-2.2) cc in the right- and left-side, respectively, p < 0.0001 each. As compared to pretreatment values, facial-tension vectors significantly increased by 2.2 (1.6-2.2) mm and 2.0 (1.7-2.2) mm in the right and left side, respectively, p < 0.0001 each. Elastography images demonstrated an increase in collagen fibers at post-treatment Day 60, which was confirmed on Day 90, and reached the peak effect between Days 90 and 180. Regarding safety, there were no either unexpected or serious treatment-related adverse events. Most patients experienced a mild redness and inflammation that resolved within the first 48 h without treatment. CONCLUSIONS: The HA/CaHa hybrid filler (HArmonyCa™), besides its volumizing and lifting properties, was associated with an increase in the viscoelasticity, both at the level of the reticular dermis and the subcutaneous cellular tissue, which might be indicative of the formation of new collagen fibers.

LL body contour technique-A new way of gluteal contouring and augmentation with hyaluronic acid filler.

INTRODUCTION: Enhancing and altering body contours has increasingly been the focus of new technologies and techniques in aesthetic treatments. The buttocks are seen as a symbol of beauty, sensuality, and attraction. PATIENTS AND METHODS: The authors described a technique for female and male gluteal augmentation. It uses a special marking, a safe plan, and a specific product. The patients chosen for this technique wanted to have an augmentation or projection effect on the buttocks, but were not willing to undergo surgery. The product used was Sofiderm Subskin Aeskins. The plan of injection was the subcutaneous as no major blood vessels were found. RESULTS: The authors report good aesthetic results with the proposed technique. The patients reported a high degree of satisfaction. DISCUSSION: The product chosen has a high G prime and a larger molecule size, which accounts for resistance to deformation and a high lifting power. Thus, result can be visible in a large body area. As the anatomy between male and female buttocks are different, different techniques were used for each gender. CONCLUSION: The LL body contour technique for gluteal augmentation proved to be a minimally invasive technique, with quick results, without major risks and downtime.

Reshaping the Lower Face Using Injectable Fillers.

The lower third is very important for the pleasant appearance of the face. A well-contoured jawline is desirable in men and women, giving a perception of beauty and youth. It is also key to sexual dimorphism, defining masculine and feminine characteristics. The nonsurgical rejuvenation and beautification of the lower third of the face is becoming more frequent. Injectable fillers can reshape the jawline, lift soft tissues, and improve facial proportions, effectively improving the appearance of the area. It is paramount to understand the facial anatomy and perform a good facial assessment in order to propose a proper aesthetic treatment plan. The aesthetic goal of the rejuvenation approach is to redefine the mandibular angle and line. In young patients, beautification can be achieved through correction of constitutional deficit or enhancement of the contour of the face, improving the facial shape. It is very important to possess knowledge of facial anatomy and of the aging process in order to deliver effective and safe results. In this article, we discuss the anatomy of the lower third of the face, facial assessment, aging process, and treatments of the chin, prejowls and mandibular line and angle with injectable fillers. The authors' experience in the approach of this area is discussed.

The Facial Shapes in Planning the Treatment with Injectable Fillers.

Introduction The facial beauty is not easy to define, yet it is paramount to assess the needs of each patient to propose an appropriate treatment plan that will provide beautification or rejuvenation in a natural-looking fashion. One of the beauty aspects easily recognized is the face shape, which can give a perception of age, gender, and attractiveness, and reflects the facial anatomical structure. Because addressing the structure of the face is the basis for the aesthetic approach with dermal fillers, we find the identification of the patient's face shape to be a very good starting point in the facial assessment. Objective To discuss important aspects of facial beauty, the characteristics of the different facial shapes (oval, heart, round, and angular), and a method of planning the aesthetic treatment with injectable fillers based on the strengths and weaknesses of each morphology of the face, that is called the AB face technique. Methods In this study, we describe seven clinical cases: two cases each of oval, heart, and round, and one case of angular shape. Results The evaluation of the face shape can help us define the priorities of the aesthetic approach, determining the areas that need to be restored in the aging face, as well as which areas could be enhanced in the younger patient. Conclusion This approach can be helpful in proposing the aesthetic treatment plan with injectable fillers to provide beautification, rejuvenation, and enhancement of the facial structure, which may benefit facial contours through aging.

Nonsurgical jawline rejuvenation using injectable fillers.

BACKGROUND: A well-defined jawline is a critical component in the perception of facial attractiveness in both men and women. Dermal fillers offer a nonsurgical, temporary method of correcting mild-to-moderate mandibular bone resorption. AIMS: The authors discuss pertinent aspects of anatomy, pathophysiology of aging, patient evaluation, gender considerations, injection technique, and complications in jawline augmentation using injectable fillers. METHODS: A brief review of the literature surrounding jawline augmentation using injectable fillers in both men and women, as well as the authors' experience in this area, is provided. RESULTS: Nonsurgical jawline augmentation using injectable fillers can be performed effectively and safely with adequate background knowledge of the regional anatomy and appropriate patient selection. The authors discuss both injection techniques in the published literature and their own approach. Potential complications are also reviewed. CONCLUSION: Jawline rejuvenation is a key component to global facial aesthetic rejuvenation. Therefore, it is important for physicians to understand how to safely and effectively perform nonsurgical jawline rejuvenation using injectable fillers.

Raman hyperspectral imaging and a novel approach for objective determination of the order of crossing ink lines.

The determination of the chronological order of crossing ink lines is a difficult problem in the examination of Questioned Documents. Modern methodologies are based on non-destructive chemical and physical analysis. However, the determination of the chronological sequence of crossing ink lines remains visual and subjective. This manuscript describes a study where Raman hyperspectral imaging is associated with different chemometric techniques and a novel method is applied for the objective determination of the chronological order of gel pen ink crossings. Eight blue and black gel pens of different brands were used to prepare 56 crossings on white paper. Raman mapping analyzed the entire crossing and the hyperspectral images were treated with k-means, Multivariate Curve Resolution - Alternating Least Squares (MCR-ALS) and Partial Least Squares - Discriminant Analysis (PLS-DA). The order of crossings was determined visually and using a novel method that consisted in calculating the relative quantity of pixels of each ink in the crossing region that were equal or higher than an established threshold. Different thresholds were tested using mean and standard deviation. The MCR-ALS and the thresholds mean minus 1,96 of the standard deviation and the mean minus 2575 of the standard deviation determined correctly more than 70% of the crossings. This method proved to be more efficient than microscopy examination and more objective since no inconclusive determinations were obtained. The methodology is promising for entirely objective and highly effective determination of the chronological sequence of crossing ink lines.

Evaluating the potential of near infrared hyperspectral imaging associated with multivariate data analysis for examining crossing ink lines.

The determination of the chronological sequence of crossing ink lines is a recurrent issue in the forensic examination of questioned documents. This manuscript intends to evaluate the potential of hyperspectral imaging in the near infrared range (HSI-NIR) combined with multivariate data analysis for rapid, objective and nondestructive analysis of crossing ink lines made with black pens. Twenty-one black gel and ballpoint pens from different brands and models were employed to prepare crossing combinations in both orders in white office paper. An initial pre-selection and extraction step using the Principal Components Analysis (PCA) scores plot arranged as histograms was necessary for extracting the inks spectra. Then, Partial Least Squares-Discriminant Analysis (PLS-DA) was applied for selection of the most important variables. Multivariate Curve Resolution-Alternating Least Squares (MCR-ALS) in the augmented form was performed using both the raw and the pre-processed spectra. However, the pre-processing of spectra resulted in incorrect identification of pixels in the inks distribution maps. The MCR-ALS results obtained using the raw spectra allowed the correct determination of the order of crossings in only one pair of gel-gel pen crossings. The remainder were either impossible to discriminate ink from paper or the skipping of one pen ink line led to incorrect determinations in one of the orders. In spite of the practical advantages of the HSI-NIR for document examination and the different chemometric approaches considered for surpassing some of the spectral limitations, the results obtained demonstrate the difficulties of using this technology for application in real forensic cases.

Determination of chronological order of crossed lines of ballpoint pens by hyperspectral image in the visible region and multivariate analysis.

Determining the chronological order of crossed lines is a recurrent problem in forensic analysis of documents. One of the most important requirement of these analyses is the use of non-destructive techniques to maintain the integrity of the documents for further analysis as judicial evidences. Thus, this work proposes an objective, non-destructive, easy-to-execute analysis protocol for forensic analysis, using the hyperspectral mode of the VSC6000®, which is an equipment found in most laboratories of questioned documents. Seven blue ballpoint pens of different brands were used to make crossings on white paper, a total of 49. The spectra were obtained from 400 to 1000 nm, and analyzed with HYPER-Tools. Initially, univariate analysis was used, selecting discriminating wavelengths to visualize the images and determine the chronological order of the crossings, and then, when necessary, a multivariate approach using Multivariate Curve Resolution - Alternating Least Squares (MCR-ALS) was applied. The interpretation of the order was made visually, taking into account characteristics of the strokes, such as the continuity and amount of ink. In this way, it was possible to determine the chronological order of 31/49 crossings, which corresponds to an overall rate of 63% accuracy. The method was validated by performing a double-blind test with 8 crossings, which indicated only a small influence of the analyst. The method was also applied to the analysis of a police inquiry, which was provided by the Federal Police and compared with the routine analyzes. The results were concordant but the proposed method provided a more objective analysis than the ones currently in practice at the Police.

The Anatomy behind Adverse Events in Hand Volumizing Procedures: Retrospective Evaluations of 11 Years of Experience.

BACKGROUND: To retrospectively evaluate the rate of adverse events after hand volumizing procedures using a calcium hydroxylapatite product and to investigate the relationship between injector used (i.e., needle versus cannula) and technique applied (i.e., bolus, tenting, proximal-to-distal fanning, distal-to-proximal single line). METHODS: Two hundred twenty individuals, including 214 women (97.3 percent) aged 52.3 ± 11.4 years, treated bilaterally for hand rejuvenation were investigated between the years 2006 and 2017. Cadaveric dissections (n = 12), fluoroscopic (n = 4), ultrasound (n = 22), and computed tomographic (n = 4) imaging were also performed to guide conclusions. RESULTS: Thirty-two of 440 hands (7.3 percent) developed adverse events within the first 15 days, with swelling in 11 (5 percent), pain in four (1.8 percent), erythema in three (1.4 percent), and discoloration in one (0.5 percent). Using a needle (versus a cannula) was significantly related to the occurrence of adverse events (OR, 7.57; 95 percent CI, 3.76 to 15.24; p < 0.001). The proximal-to-distal fanning technique with access to the dorsal superficial lamina was identified as a safer application technique, with each of the other techniques having a significantly increased odds ratio for adverse events: bolus technique (OR, 26.9; 95 percent CI, 6.87 to 105.2; p < 0.001), tenting technique (OR, 24.73; 95 percent CI, 7.48 to 81.76; p < 0.001), and single-line technique (OR, 26.68; 95 percent CI, 7.45 to 95.48; p < 0.001). CONCLUSIONS: The results of this study support the use of cannula versus needle and the proximal-to-distal fanning technique. The underlying anatomy supports the positioning of the material into the subdermal space, which can be identified less than 1 mm deep to the skin surface, and is termed the dorsal superficial lamina.

The Male Aesthetic Patient: Facial Anatomy, Concepts of Attractiveness, and Treatment Patterns.

BACKGROUND: The number of nonsurgical aesthetic procedures performed in men is growing rapidly. However, there are limited data on treatment principles and goals for the male aesthetic patient.

OBJECTIVE: To review the objective data available on male aging and aesthetics and to synthesize with expert opinion on treatment considerations specific to male patients.

METHODS: Expert advisors met to discuss anatomical differences in male versus female facial anatomy related to aging, facial treatment preferences in aesthetically oriented men, and current dosing data for facial injectable treatments in male versus female patients.

RESULTS: Symmetry, averageness, sexual dimorphism, and youthfulness are generally accepted as factors that contribute to the perception of attractiveness. There are differences between men and women in facial anatomy, concepts of attractiveness in the context of masculinity and femininity, and treatment objectives. A communication gap exists for men, as evidenced by the lack of information available online or by word of mouth about injectable treatments.

CONCLUSIONS: Approaches to aesthetic consultation and treatment should differ between men and women based on the fundamental dissimilarities between the sexes. Educating men about available aesthetic treatments and about the safety and side effects associated with each treatment, as well as addressing concerns about their treatment results looking natural, are key considerations.

J Drugs Dermatol. 2018;17(1):19-28.

Combined aesthetic interventions for prevention of facial ageing, and restoration and beautification of face and body.

The Merz Institute of Advanced Aesthetics Expert Summit was held in Prague, Czech Republic, from 19-20 November 2016. The meeting had a distinct advisory board character and invited aesthetic practitioners from all over the world to hear an international faculty present a range of keynote lectures and conduct live injection sessions with an emphasis on recent developments in combination aesthetic interventions for face and body rejuvenation and beautification. Aging is associated with changes in bones, muscles, ligaments, adipose tissue, and skin and, moreover, involves interactions among these tissue types. To achieve the most natural and harmonious rejuvenation of the face, all changes that result from the aging process should be corrected, which generally involves treatment with more than a single agent or technology. Presentations described innovative treatment algorithms for the face and body and focused on patients' desires for natural-looking rejuvenation and how this requires a three-dimensional approach combining products that relax the musculature, volumize, and re-drape the skin. Besides treating the aging face, these procedures are increasingly used to enhance facial features as well as to delay facial aging in younger patients. The presentations covered patients from different ethnicities as well as the treatment of non-facial areas, with a particular focus on the use of Ultherapy® for skin lifting and tightening, and new aesthetic procedures such as Cellfina® and diluted Radiesse®. The current report provides a summary of key presentations from the meeting.

Facial Assessment and Injection Guide for Botulinum Toxin and Injectable Hyaluronic Acid Fillers: Focus on the Midface.

This second article of a three-part series addresses techniques and recommendations for aesthetic treatment of the midface. Injectable fillers are important for rejuvenation of the midface by replacing lost volume and providing structural support; neuromodulators play a smaller role in this facial region. Fillers are used for volumization and contouring of the midface regions, including the upper cheek and lid-cheek junction and the submalar and preauricular areas. Also, treatment of the frontonasal angle, the dorsum, the nasolabial angle, and the columella may be used to shape and contour the nose. Neuromodulators may be used to treat bunny lines and for elevation of the nasal tip. The midface is considered an advanced area for treatment, and injectors are advised to obtain specific training, particularly when injecting fillers near the nose, because of the risk of serious complications, including blindness and necrosis. Injections made in the midcheek must be performed with caution to avoid the infraorbital artery.

First Consensus on Primary Prevention and Early Intervention in Aesthetic Medicine.

BACKGROUND: Facial aging is a complex interplay of extrinsic and intrinsic factors leading to progressive changes in the skin, subcutaneous tissue, and bone. Clinical experience suggests that early aesthetic intervention may slow the signs of aging, but treatment in the absence of symptoms or with minimal signs of aging has not yet been properly addressed. OBJECTIVES: To provide treatment recommendations for primary prevention and early intervention in individuals with no or minimal signs of aging. METHODS: Fourteen specialists in aesthetic medicine convened over a full-day meeting under the guidance of a certified moderator. RESULTS: Tailored treatment recommendations have been provided for prevention and early intervention of fine wrinkles, static lines and folds, irregular pigmentation, laxity, and subcutaneous volume loss by protecting the epidermis, stimulating neocollagenesis, reducing hyperkinetic musculature, and reinforcing supporting structures. CONCLUSION: Preventive measures and early therapeutic interventions that may alter the course of facial aging were defined. Further studies are needed to support these recommendations with the best possible evidence.

J Drugs Dermatol. 2017;16(9):846-854.

Communication Concepts for Prevention and Early Intervention in Aesthetic Medicine: Consensus and Literature Review.

BACKGROUND: Communication concepts relating to prevention and early intervention (P&E) within aesthetic medicine are poorly understood and highly underexplored. However, effective communication is a key criterion for successful outcomes. OBJECTIVES: To introduce the framework for P&E communication strategies within a younger population and explore the barriers that may be encountered. METHODS: A literature review on P&E communication strategies in aesthetic medicine and related topics of interest was conducted and used to construct a working framework that may be applied in clinical practice. RESULTS: Examination of existing literature revealed a need for a more structured communication framework for P&E encompassing up-to-date evidence-based learning and educational marketing that is tailored to individual needs and target populations. Message framing-the way in which a message is presented-is an important consideration in the dissemination of information to promote changes in health behaviour. A structured consultation is key to optimising patient engagement and ensures a tailored approach to understanding and catering to the specific needs of each patient. CONCLUSION: This is the first paper to discuss the communication concepts behind P&E within aesthetic medicine and paves the way for further research and focus in this significant field.

J Drugs Dermatol. 2017;16(9):859-864.

Diagnóstico e tratamento dos eventos adversos do ácido hialurônico: recomendações de consenso do painel de especialistas da América Latina / Diagnosis and treatment of hyaluronic acid adverse events: Latin American expert panel consensus recommendations

Introdução: Na última década, o uso do preenchimento com ácido hialurônico para aprimoramento facial aumentou na América Latina. O preenchimento com ácido hialurônico é considerado seguro com baixa incidência de eventos adversos. Como eventos adversos são pouco observados na prática clínica ou têm sido possivelmente sub-relatados são necessárias mais orientações para diagnosticar e tratar eventos adversos relacionados ao ácido hialurônico. Objetivo: Compreender melhor os eventos adversos relacionados ao ácido hialurônico e propor recomendações para o diagnóstico e tratamento. Métodos: Reunião em painel de 25 especialistas médicos multidisciplinares da América Latina foi realizada em São Paulo, Brasil, para discutir o que se conhece sobre eventos adversos relacionados ao ácido hialurônico e fornecer conhecimentos baseados na experiência clínica. Por meio de consenso, foram desenvolvidos recomendações e algoritmos. Resultados: O painel categorizou eventos adversos relacionados ao ácido hialurônico baseado em três momentos de início (imediato, precoce e tardio) e propôs um novo termo para eventos adversos que apresentam edema tardio intermitente persistente ("Etip"). Foram criados algoritmos para diagnóstico e tratamento em cada momento. Conclusões: Novos algoritmos consensuais para diagnósticos e tratamentos associados ao momento de início dos eventos adversos relacionados ao ácido hialurônico orientarão melhores práticas no uso clínico do preenchimento com ácido hialurônico.

Introduction: In the last decade, the use of hyaluronic acid fillers for facial enhancement has increased in Latin America. Hyaluronic acid fillers are considered relatively safe with a low incidence of adverse events. Because adverse events are not seen frequently in clinical practice or have been potentially underreported, there is a need for more guidance on the diagnosis and treatment of Hyaluronic acid-related adverse events. Objecti ve: To provide an enhanced understanding of hyaluronic acid-related adverse events and to propose recommendations for their diagnosis and treatment. Methods: A 25-member multi-disciplinary expert panel meeting of Latin-American physicians was convened in Sao Paulo, Brazil to discuss what is known about hyaluronic acid-related adverse events and to provide insights based on clinical experience. Recommendations and algorithms were developed through a consensus process. Results: The panel categorized hyaluronic acid-related adverse events based on 3 time frames of onset (immediate, early and Late) and proposed a new term for adverse events that display persistent, intermittent, delayed Swelling (PIDS). Algorithms were created for diagnosis and treatment for each time frame. Conc lusions: The new consensus algorithms for time-related diagnosis and treatment of hyaluronic acid-related adverse events will provide guidance for best practices in the clinical use of hyaluronic acid fillers.

Global Aesthetics Consensus: Avoidance and Management of Complications from Hyaluronic Acid Fillers-Evidence- and Opinion-Based Review and Consensus Recommendations.

BACKGROUND: Although the safety profile of hyaluronic acid fillers is favorable, adverse reactions can occur. Clinicians and patients can benefit from ongoing guidance on adverse reactions to hyaluronic acid fillers and their management. METHODS: A multinational, multidisciplinary group of experts in cosmetic medicine convened the Global Aesthetics Consensus Group to review the properties and clinical uses of Hylacross and Vycross hyaluronic acid products and develop updated consensus recommendations for early and late complications associated with hyaluronic acid fillers. RESULTS: The consensus panel provided specific recommendations focusing on early and late complications of hyaluronic acid fillers and their management. The impact of patient-, product-, and technique-related factors on such reactions was described. Most of these were noted to be mild and transient. Serious adverse events are rare. Early adverse reactions to hyaluronic acid fillers include vascular infarction and compromise; inflammatory reactions; injection-related events; and inappropriate placement of filler material. Among late reactions are nodules, granulomas, and skin discoloration. Most adverse events can be avoided with proper planning and technique. Detailed understanding of facial anatomy, proper patient and product selection, and appropriate technique can further reduce the risks. Should adverse reactions occur, the clinician must be prepared and have tools available for effective treatment. CONCLUSIONS: Adverse reactions with hyaluronic acid fillers are uncommon. Clinicians should take steps to further reduce the risk and be prepared to treat any complications that arise.