Effectiveness and Safety of a New Hyaluronic Acid Injectable for Augmentation and Correction of Chin Retrusion.

BACKGROUND: A hyaluronic acid (HA) filler intended for non-surgical improvement of chin appearance should ideally be of high strength/firmness (high G') to allow for deep injections on the bone. HASHA (Restylane Shaype) is a new hyaluronic acid (HA) injectable with high G' and high HA concentration (25 mg/mL), engineered by the new NASHA-HD (High Definition) technology. HASHA is suitable to be placed periosteally, aiming to mimic the natural shape of the bony chin. This pivotal clinical investigation evaluated effectiveness and safety of HASHA for augmentation and correction of chin retrusion.  Methods: Subjects 18 years or older with mild or moderate chin retrusion by the Galderma Chin Retrusion Scale (GCRS), were randomized 3:1 to HASHA (n=103) or no treatment (n=37). Assessments included GCRS (blinded evaluator), aesthetic improvement (Global Aesthetic Improvement Scale [GAIS]), subject satisfaction, and safety.  Results: GCRS responder rate (1-grade or greater improvement from baseline) was significantly higher for HASHA (83.3%) versus controls (10.8%) at month 3 (P<0.001) and maintained through month 12 (P<0.001). Aesthetic improvement was high throughout the study in the HASHA group, according to investigators (97% or greater) and subjects (89% or greater). Overall, subject satisfaction was high at month 3 and maintained at month 12. Product- or injection-related adverse events were mostly mild or moderate and transient. No product- or injection-related serious adverse events were reported. CONCLUSIONS: HASHA, a new NASHA-HD injectable with extra strength/firmness, was safe and effective for chin augmentation and correction of chin retrusion, with high aesthetic improvement and subject satisfaction throughout 12 months. J Drugs Dermatol. 2024;23(4):255-261.     doi:10.36849/JDD.8145.

Restoring long-lasting midface volume in the Asian face with a hyaluronic acid filler: A randomized controlled multicenter study.

BACKGROUND: Hyaluronic acid (HA) filler treatment is a minimally-invasive alternative to surgery to volumize the cheeks. HAVOL (Restylane® Volyme) is a flexible HA filler suited to contouring and volumizing the midface. METHODS: This randomized, evaluator-blinded, no-treatment controlled study evaluated effectiveness and safety of HAVOL for correction of midface volume deficit and midface contour deficiency in Chinese subjects. In total 111 subjects were randomized to HAVOL and 37 to no treatment (control). The primary endpoint was response, on the blinded evaluator-assessed Medicis Midface Volume Scale (MMVS), at 6 months after last injection for the treatment group and 6 months after randomization for controls, where response was defined as ≥1-point improvement from baseline on both sides of the face. RESULTS: HAVOL was superior to no treatment at 6 months, meeting the primary objective: 76% versus 8% MMVS responders, a difference of 68% (CI: 55.7%-79.4%, p < 0.0001). These effects were sustained in 51% at 12 months after last injection. A majority (≥96%) had improved aesthetic appearance of midface fullness at Month 1 (using the Global Aesthetic Improvement Scale [GAIS]), effects which remained in ≥80% up to 12 months. Volume change captured by 3D photography increased after 1 month to 3.6 mL (close to the total injected volume of 3.4 mL), and remained stable through 12 months. Over 97% reported satisfaction with results after treatment with HAVOL. Additionally, HAVOL was well tolerated, with no unanticipated related adverse events. CONCLUSIONS: This study showed that HAVOL is effective and well tolerated for midface treatment in a Chinese population.

Investigating the impact of added Profhilo mesogel to subcision versus subcision monotherapy in treating acne scars; a single-blinded, split-face randomized trial.

BACKGROUND: Acne scar is an inflammatory condition, which commonly occurs in patients with acne vulgaris, especially in adults. Mesogels have been reported effective in improving atrophic acne scars. AIMS: We investigated the efficacy of adding Profhilo (a hyaluronic acid-based filler) to subcision as a new treatment method. METHODS: Twelve patients aged 18-45 years with atrophic acne scars on both sides of the face participated in this single-blinded, split-face, randomized controlled trial. Each side of the face was randomly assigned to one of the treatment methods, including subcision alone and subcision + Profhilo. Patients in the Profhilo arm received mesogel (1 cc) in addition to the subcision procedure. Both methods were carried out two times at 1-month intervals. Assessments were done based on the sonographic depth of scars, and two blinded observers examined photographs at baseline and 3 months after the final session and the results were reported based on an exclusively made formula as the total score. The Global Improvement Scale and Visual Analogue Scale (VAS) (for patient satisfaction) were also used. RESULTS: The VAS score of patient satisfaction was statistically significant in the Profhilo arm, with a mean improvement of 528.08 and 219.06 in the subcision arm (p = 0.02). No significant difference was seen in total acne scar reduction comparing the two methods (29.74 in the Profhilo arm and 22.27 in the subcision arm, p = 0.56). Sonographic depth reduction was also non-significant, with a mean of 29.21 in the Profhilo arm and 28.53 in the subcision arm (p = 0.4). The mean global improvement was reported as four in both arms, and no statistical significance was observed (p = 0.89). The best response to treatment belonged to the rolling subtype in both methods (p = 0.029 for the Profhilo arm and p = 0.001 for the subcision arm). CONCLUSION: Despite no significant difference between the methods, Profhilo is more effective due to a higher satisfaction rate and better physiologic effects.

Revitalizing the lower face: Therapeutic insights and an innovative treatment guideline for jowl rejuvenation.

BACKGROUND: The intricate mechanisms of jowl formation, which ultimately lead to loss of lower jaw definition, skin laxity, and localized fat accumulation, involve interrelated factors such as skin aging, fat redistribution, muscle dynamics, and loss of support. AIMS: To propose a structured approach to the treatment of the jowl area that is comprehensive and tailored to the needs of each individual patient. MATERIALS AND METHODS: This integrative review combines a meticulous analysis of the literature with practical insights from real-world clinical settings. The authors draw on their extensive clinical experience to bridge research findings with practical clinical perspectives. RESULTS: This study presents a guideline for addressing jowl formation that starts with the major aging processes and, based on simple diagnostic questions, suggests minimally invasive interventions, including collagen stimulators, energy-based devices, lipolytic injectables, polydioxanone threads, and hyaluronic acid fillers. DISCUSSION: The guideline emphasizes the significance of personalized treatments while also acknowledging the need for comprehensive evaluation and recognizing the ever-evolving nature of aesthetic interventions in jowl management. CONCLUSION: This systematic approach can not only simplify diagnostic and treatment decisions for dermatologists but also enhance patient satisfaction by customizing treatment plans based on individual characteristics and expectations.

Anatomy of the temporal region to guide filler injections.

Hollow temples are not typically considered aesthetically pleasing, and hollowness worsens with the aging process. When filling this region with fillers, there are several anatomical considerations, with injection techniques varying depending on the layer targeted. Specifically, injections between the superficial temporal fascia and the superficial layer of the deep temporal fascia are performed using a cannula, while periosteal layer injections involve the use of a needle to reach the bone before inserting fillers. Detailed anatomical insights encompass the boundaries of the temporal fossa and cautionary notes regarding blood vessels, supported by specific studies on veins and arteries in the temporal region. Complications, including vessel injuries, are discussed alongside an exploration of various injection techniques. This review provides a comprehensive exploration of anatomical considerations and the specific methodologies employed in temple augmentation with fillers.

Prospective comparative clinical study: Efficacy evaluation of collagen combined with hyaluronic acid injections for tear trough deformity.

BACKGROUND: Tear trough filling is a popular facial rejuvenation procedure, and hyaluronic acid is typically used as the filler of choice. However, Tyndall's phenomenon, a common complication following hyaluronic acid injection, can occur, leading to skin discoloration of the lower eyelid. AIMS: This single-center, prospective, comparative clinical study aimed to evaluate the efficacy of collagen and hyaluronic acid injections in treating tear trough deformity. METHODS: Sixty patients were enrolled between June 2022 and January 2023. Patients were randomly allocated into three groups: Group A received hyaluronic acid, Group B received hyaluronic acid combined with collagen, and Group C received collagen alone. Baseline characteristics, including age, sex, and tear trough deformity grade were considered before therapy. Changes in tear trough deformity scores, Global Aesthetic Improvement Scores, and the presence of the Tyndall effect were analyzed at 1 and 3 months postinjection to determine differences among the three groups. RESULTS: Baseline profiles of the three groups were similar. In the first month postinjection, there was no difference in the Global Aesthetic Improvement Scores and tear trough deformity between the three groups. However, in the third-month postinjection, there was a significant difference in scores between patients in Group C and those in Groups A or B. The Tyndall effect manifested in three patients in Group A, which was significantly different from that in Groups B and C. CONCLUSION: The combined use of hyaluronic acid with collagen in injectable fillers corrected tear trough deformities and reduced the occurrence of the Tyndall phenomenon, which can be problematic with hyaluronic acid alone. Additionally, this combination may help overcome the disadvantage of a shorter retention period when using collagen alone.

The Use of Facial Fillers in Clinical Practice: The Level of Patient Satisfaction and an Overview of Common Clinical Complications. / [Artículo traducido] Uso de rellenos faciales en la práctica clínica: nivel de satisfacción del paciente y visión general de las complicaciones clínicas comunes.

BACKGROUND: Patient esthetic satisfaction following facial fillers is an essential topic that should be studied as the number of individuals seeking treatment increases. The face is an essential component of the human body that is frequently associated with beauty, youthfulness, and health. Individuals may seek facial augmentation with fillers for a variety of reasons, such as congenital, acquired by means of aging or disease, or current aesthetic trends. OBJECTIVE: The aim is to assess patient's aesthetic satisfaction and description of common clinical complications in relation to the facial filler injections. METHOD: A cross sectional survey using a questionnaire derived from the global aesthetic improvement scale and WHO quality of life scale, convenience sampling was used to recruit patients attending cosmetic clinics, descriptive analysis and Chi-square methods were used to analyze the data. RESULTS: In the study, 500 female participants, with an average age of 28.48 years, were included. Over 90% reported improvement after filler treatment, ranging from improved to very much improved. A statistically significant correlation was observed between patient satisfaction and the number of filler treatments and the anatomical injection site. However, no statistically significant correlation was found when considering age groups. Local side effects, such as swelling and redness at the injection site, were common but generally mild and of short duration. CONCLUSION: Although the satisfaction level is currently high, practitioners in the field need to pay more attention to this important outcome, since understanding the patient's motivation and expectation before proceeding with the procedure is very important and can contribute significantly in determining patient satisfaction with the result.

Chin Augmentation and Treatment of Chin Retrusion with a Flexible Hyaluronic Acid Filler in Asian Subjects: A Randomized, Controlled, Evaluator-Blinded Study.

BACKGROUND: Aesthetic improvement of the chin is increasingly requested by patients, including those of Chinese origin. METHODS: A randomized, evaluator-blinded, no-treatment controlled study evaluated the effectiveness and safety of a flexible hyaluronic acid (HA) filler, Restylane® DefyneTM (HADEF), in the correction of chin retrusion in a Chinese adult population over 12 months after treatment. On Day 1, subjects were randomized 3:1 into two groups, HADEF or delayed-treatment controls, and those in the HADEF group were administered treatment. An optional touch-up treatment was administered 1 month after treatment to obtain optimal chin augmentation. The initially untreated control group was offered delayed-treatment after 6 months (including 1-month touch-up). RESULTS: HADEF was superior to no-treatment in improving chin retrusion according to the blinded evaluator at 6 months [Galderma Chin Retrusion Scale (GCRS) responder rate (≥ 1-point improvement from baseline) of 81% vs. 5% for untreated controls; p < 0.001, meeting the primary effectiveness objective. A majority of subjects maintained improvement at 12 months (61% in the HADEF group). All subjects reported satisfaction with results at 6 months after treatment with HADEF and aesthetic improvement rates per the global aesthetic improvement scale (GAIS) were high for 12 months following treatment, with an acceptable safety profile. CONCLUSIONS: These results demonstrated HADEF to be effective and safe for the correction of mild-to-moderate chin retrusion in Chinese subjects, confirming findings previously observed in a western population. LEVEL OF EVIDENCE I: 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 .

Causes and management of sight threatening complications of dermal filler injections: A review.

Injectable dermal fillers continue to increase in popularity in aesthetic medicine. Although rare, vision loss secondary to filler injections is a devastating complication associated with a poor visual prognosis. The mechanism for vision loss is thought to be related to retrograde embolization of the dermal filler from peripheral vessels in the face into the ophthalmic arterial system. Early recognition and prompt management are essential if vision is to be salvaged. The use of retrobulbar hyaluronidase is still contentious, however when administered by a specialist, this treatment gives the best chance at visual recovery and should be considered for all cases.

A Natural Flat Volumized Lips Filler Technique: Retrospective Analysis of 920 Patients.

BACKGROUND: Traditionally, hyaluronidase (HYAL) is used after hyaluronic acid (HA) injection to dissolve the undesired migration of product. OBJECTIVE: To describe a novel lip augmentation technique that uses HA and HYAL simultaneously in patients who previously had HA migration. METHODS AND MATERIALS: Nine hundred twenty female patients were included. In the first group ( n = 793), HA injections were performed in subcutaneous plane of the lips. In the second group who had previous product migration ( n = 127), 7.5 units of HYAL is injected in 4 points in ergotrid area before proceeding with HA injection. RESULTS: The medicis lip fullness scale scores after 2 weeks improved in all patients, while 92% of patients perceived the results as "very much improved" with Global Aesthetic Improvement Scale ( p ˂ .001). There was no difference between 2 groups regarding the patient satisfaction rates ( p ˃.05), while filler migration was seen in 0.2% ( n : 15) of patients in the first group during the follow-up period. CONCLUSION: The new vertical injection approach provided an increased vertical height, optimal eversion, and an incisor display on the lips. The simultaneous use of HYAL before HA injection seems to be a safe and effective practice in 1-stage treatment of the previously injected lips with filler migration into ergotrid area.

A treatment algorithm for hyaluronic acid filler related complications of the face.

BACKGROUND: Throughout the last decade, a notable increase in HA-filler-related complications have been observed, owing to the increase in demand for filler injections and availability of multiple products. OBJECTIVES: The aim is to provide practical advice on the best way to prevent and treat HA-filler-related complications. METHODS: Thirty patients who experienced visible and/or symptomatic complications localized within the facial area were treated according to our algorithm. Patients with inflammatory lesions underwent antibiotic and anti-inflammatory therapy, followed by hyaluronidase injections. Patients with abscesses were treated with antibiotics, incision, and drainage. Each patient completed the dermatology-specific quality of life questionnaire (DLQI) at the first and last examinations. RESULTS: Among the 29 patients who received antibiotic therapy, 3 healed without further treatment. However, 18 received hyaluronidase injections, 9 underwent incision and drainage, and 5 presented with fistulas and developed retracted scars. Moreover, 80% of the patients were completely healed, 13% significantly improved, and 3% did not show any improvement. The DLQI scores analysis showed a notable impact of patients' diseases on their quality of life, mainly in the terms of personal relationships and symptoms, with minor impacts on intimate relationships, ability to work, and study. We demonstrated that our algorithm resulted in a significant improvement in the overall quality of life at the last follow-up (p < 0.001). CONCLUSIONS: The use of filler injections requires caution and specific training because they can lead to serious complications. If these complications are recognized promptly, healing can be optimized. Our treatment algorithm demonstrated high rate of healing and significant improvement in the patients' quality of life.

A Cross-Sectional Survey on Pain Management in Dermal Filler Injections from Physicians' and Patients' Perspectives.

BACKGROUND: Hyaluronic acid (HA) dermal fillers injection is a common procedure in patients with cosmetic needs. Concomitant pain is a major complaint among patients undergoing HA filler injections. Relevant research is limited and there is no consensus on pain management of dermal filler injection. OBJECTIVES: To assist physicians in determining a more appropriate treatment approach, and to better provide treatment suggestions. METHODS: A nationwide (China) cross-sectional survey was conducted using questionnaires designed for physicians and patients, respectively. A total of 62 semi-structured questionnaires were administered to aesthetic physicians via face-to-face interview, whereas 123 online-based questionnaires were collected from patients who have ever undergone HA treatment. The collected questionnaire information was analyzed using descriptive statistics and content analysis. RESULTS: 42 (67.74%) physicians observed that over 50% of their patients were concerned about pain during injection. 101 (82.11%) of patients were concerned about impending pain ≥5 points (a total score is 10) before injection. For preferred pain relief modalities, 48 (77.42%) physicians would choose a hyaluronic acid dermal filler with lidocaine, and 82 (66.67%) patients would choose anesthetic-containing products. 59 (95.16%) physicians who injected lidocaine-containing hyaluronic acid found patients had a comfortable treatment experience. CONCLUSIONS: Pain management during hyaluronic acid dermal fillers injection is important from both perspectives of physicians and patients. This survey showed that compared with other analgesic methods, lidocaine-containing hyaluronic acid has offered a more satisfying experience. It also provides insights to physicians and patients in pain management. LEVEL OF EVIDENCE V: 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 Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Dilutional rheology of Radiesse: Implications for regeneration and vascular safety.

BACKGROUND: Calcium hydroxylapatite-carboxymethylcellulose (CaHA-CMC) injectables have emerged as dual-purpose fillers with bioregenerative and direct filling capabilities. AIMS: This study investigates the rheological properties of CaHA-CMC and its CMC carrier gel at various dilutions. METHODS: The storage modulus (G'), loss modulus (G″), complex viscosity (η*), loss factor (tan δ), cohesivity, and extrusion force were evaluated for a range of CaHA-CMC aqueous dilutions with an oscillatory rheometer, drop weight testing, and force analysis, respectively. RESULTS: Results revealed a significant decrease in G', η*, and increase in tan(δ) with increasing dilution, indicating a decline in the product's direct filling capabilities. Cohesivity decreased dramatically with dilution, potentially enhancing tissue biointegration and the product's biostimulatory effects. The CMC gel carrier displayed inelastic and non-resilient properties, with rheological changes differing from CaHA-CMC. Dilutional rheology was also correlated with previously published dilution-dependent biostimulatory data where hyperdiluted CaHA-CMC (>1:2) demonstrated a regenerative profile and diluted or hypodiluted mixtures retained meaningful filling properties and increased regeneration. CONCLUSIONS: These findings offer a continuum for tailoring the product's rheological profile to match specific tissue requirements. Customizable rheology allows CaHA-CMC to be tuned for either filling and contouring or optimal regenerative effects. Importantly, safety implications related to vascular occlusion suggest that dilutional rheomodulation decreases the risk of vascular events. In conclusion, this study highlights the significant impact of aqueous dilution on the rheological properties of CaHA-CMC and its carrier gel. The findings support the clinical application of tailored dilutions to achieve desired outcomes, providing versatility and safety for aesthetic applications.

Exploring facial overfilled syndrome from the perspective of anatomy and the mismatched delivery of fillers.

INTRODUCTION: Facial fillers and injectables have transformed the landscape of cosmetic procedures, offering rejuvenation possibilities. However, the emergence of "Facial Overfilled Syndrome (FOS)" presents a concerning trend attributed to excessive filler use and suboptimal injection techniques. Understanding the interplay between facial aging and augmentation techniques is crucial in addressing and preventing FOS. MATERIAL AND METHODS: Facial overfilled syndrome is characterized by the excessive use of fillers, resulting in a distorted and heavy appearance. It manifests in various forms, including 'flowerhorn' foreheads, 'sunset' eyes, 'chipmunk' cheeks, 'witch' chins, and 'pillow' faces. The syndrome arises from attempts to combat anatomical aging with dramatic filler treatments, causing rapid volume changes and skin tightening. Skeletal structures and soft tissue distribution across different ethnicities play a significant role in FOS development. RESULTS: Understanding the aging process across facial tissues is essential, as fillers cannot entirely reverse aging manifestations. Tailored assessment and treatment plans should precede filler injections, involving muscle assessment, observation of facial movements during injection, and ultrasound imaging of fat layers. Attention should be given to filler pressure and migration risks, particularly in areas with elevated pressure. Additionally, alternative approaches like energy-based devices and polymer reinforcement of facial ligaments should be considered to minimize filler use. Ethnic variations in facial anatomy require careful consideration to avoid overcorrection. CONCLUSION: FOS predominantly affects individuals of East Asian descent due to specific facial characteristics. Prevention strategies involve minimizing filler use, addressing underlying bone changes, and considering ethnic and gender differences in facial anatomy. Recent MRI and ultrasound studies challenge the notion of filler breakdown, emphasizing the importance of filler selection and injection techniques. Education, individualized treatments, and a holistic understanding of facial anatomy are key to preventing and managing FOS and ensuring natural and harmonious facial aesthetics.

Impurities in Hyaluronic Acid Dermal Fillers? A Narrative Review on Nonanimal Cross-Linked Fillers.

Importance: Nonanimal cross-linked hyaluronic acid (HA) dermal fillers are among the most versatile tools in minimal invasive esthetic medicine. Filler injections aim to volumize, provide contour, and reduce wrinkles and skinfolds. In the hand of the experienced user, HA fillers have an excellent safety profile. Nevertheless, adverse events have been reported related to poor injection techniques, infection, and immune reactions. Observations: In this review, the focus is on filler impurities. Impurities can originate from the fermentation process, crosslinking, packaging, and contamination. Impurities consist of particular and nonparticular matter. We discuss possible risks for the patient to be treated with HA fillers. Conclusions and Relevance: Impurities of dermal fillers bear a potential risk for patients, such as delayed autoimmune and inflammatory reactions, biofilm formation, and exposure to leachable Endocrine Disrupting Chemicals. Amount and quality of impurities can be considered as one of the quality parameters of commercially fillers. Considering patient safety, filler impurities should be further reduced.

Complications of Injectables.

The field of non-surgical esthetic procedures has witnessed a significant surge in demand in recent years, with neuromodulators, skin treatments, and dermal fillers contributing significantly to the industry's growth. These procedures have become increasingly popular, reflecting the broader acceptance of esthetic enhancements in society. Neuromodulators play a pivotal role in facial rejuvenation, but they require precise knowledge of facial anatomy to optimize results and prevent complications. They include rare hypersensitivity reactions, local injection reactions, and brow and eyelid ptosis. Dermal fillers, both non-permanent and permanent, are widely used to restore volume and improve facial contours. However, they also carry risks, including bruising, temporary edema, and lumps. Permanent fillers present higher complication rates, and their use should be approached with caution. Vascular occlusion is a rare but severe complication associated with dermal fillers. To mitigate these risks, practitioners must have a comprehensive understanding of their compositions and potential complications. Overall, while non-surgical esthetic procedures offer remarkable results with minimal downtime, the importance of training, anatomic knowledge, and effective complication management cannot be overstated in ensuring patient safety and satisfaction in this evolving field of medicine.

The Use of Hyaluronidase in Aesthetic Practice: A Comparative Study of Practitioner Usage in Elective and Emergency Situations.

BACKGROUND: Hyaluronic acids (HAs) continue to be the fillers of choice worldwide and their popularity is growing. Adverse events (AEs) are able to be resolved through the use of hyaluronidase (HYAL). However, routine HYAL use has been at issue due to perceived safety issues. OBJECTIVES: There are currently no guidelines on the use of HYAL in aesthetic practice, leading to variability in storage, preparation, skin testing, and beliefs concerning AEs. This manuscript interrogated the use of this agent in daily practice. METHODS: A 39-question survey concerning HYAL practice was completed by 264 healthcare practitioners: 244 from interrogated databases and 20 from the consensus panel. Answers from those in the database were compared to those of the consensus panel. RESULTS: Compared to the database group, the consensus group was more confident in the preparation of HYAL, kept reconstituted HYAL for longer, and was less likely to skin test for HYAL sensitivity and more likely to treat with HYAL in an emergency, even in those with a wasp or bee sting anaphylactic history. Ninety-two percent of all respondents had never observed an acute reaction to HYAL. Just over 1% of respondents had ever observed anaphylaxis. Five percent of practitioners reported longer-term adverse effects, including 3 respondents who reported loss of deep tissues. Consent before injecting HA for the possible requirement of HYAL was always obtained by 74% of practitioners. CONCLUSIONS: Hyaluronidase would appear to be an essential agent for anyone injecting hyaluronic acid filler. However, there is an absence of evidence-based recommendations with respect to the concentration, dosing, and treatment intervals of HYAL, and these should ideally be available.