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.

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.

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.

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 .

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.

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 .

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.

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.

Morphea-like discoid lupus erythematosus in a patient with a history of polyacrylamide gel injection: A case report.

BACKGROUND: Discoid lupus erythematosus (DLE) is an autoimmune disease with multifactor etiology which develops in genetically susceptible patients. Rarely, DLE lesions can mimic other connective tissue disorders such as morphea. The growing application of soft tissue fillers is associated with increasing complications. Some substances used for soft tissue augmentation such as silicon implants may trigger lupus erythematosus diseases. CASE REPORT: Here we report a case of morphea-like discoid lupus erythematosus developed several years after polyacrylamide dermal filler (PAAG) injection for facial rejuvenation. CONCLUSION: As noninvasive procedures like dermal filler injections are increasing worldwide, physicians may consider the long-term probable side effects of these compounds.

Multifocal strokes and vision loss from PDLLA filler injections.

BACKGROUND: Poly-D, L-lactic acid (PDLLA) is increasingly used as a commercial dermal filler due to its lasting cosmetic properties. Consequently, PDLLA-related vascular complications are increasingly recognized and described. Herein, we describe the first known occurrence of multifocal strokes from the use of PDLLA as a cosmetic dermal filler, and discuss the mechanisms facilitating PDLLA's entry into the intracranial arterial system. CASE PRESENTATION: A middle-aged female presented with acute vision loss of both eyes immediately after dermal injections of PDLLA to her nasolabial folds and infraorbital regions. There were no additional neurological deficits. Dilated fundal examination revealed retinal edema bilaterally, with deposition of filler material in the retinal arteries. Magnetic resonance imaging of her brain and orbits demonstrated multifocal strokes (left caudate head, right medial frontal lobe) and ischemia of the left optic nerve. The temporal proximity of the dermal injections to her symptoms, guided by fundal examination and neuroimaging findings, allowed us to attribute her strokes and ischemic optic neuropathy to PDLLA's entry into, and embolism within, the intracranial arterial system. She was treated with hyperbaric oxygen therapy and experience improvement to her right eye's vision, although poor vision persisted in her left eye. CONCLUSION: While PDLLA is generally considered safe, its increasing use as a cosmetic filler renders it crucial for physicians to be cognizant of its vascular complications, especially when early recognition and treatment are essential in mitigating their devastating ramifications.

Does injecting small amounts of fillers prevent the development of secondary blindness?

INTRODUCTION: Inadvertent entry of filler products into the supratrochlear, supraorbital, or dorsal nasal arteries, among other branches of the ophthalmic artery, might result in an immediate and devastating loss of vision. We wanted to examine how much filler could block the ophthalmic artery. MATERIALS AND METHODS: Twenty-nine fresh cadavers were examined. We exposed the arterial supply to the opthalmic artery by dissecting the orbital area. Thereafter, 17 filler injections were introduced into the supratrochlear, supraorbital, and dorsal nasal arteries each. The amount of filler injection that completely blocked the ophthalmic artery was measured. Additionally, one of the head specimens was processed using phosphotungstic acid-based contrast enhancement micro-computed tomography to analyze each arteries to obstruct its whole ophthalmic artery. RESULTS: The supratrochlear, supraorbital, and dorsal nasal arteries had mean volumes in milliliter (mean ± standard deviation) of 0.0397 ± 0.010 mL, 0.0409 ± 0.00932 mL, and 0.0368 ± 0.00732 mL, respectively. However, the arteries did not differ significantly. CONCLUSION: Even a modest amount of filler injection can completely block the ophthalmic artery, resulting in visual loss.

The Use of Hyaluronic Acid in Non-surgical Rhinoplasty: A Systematic Review of Complications, Clinical, and Patient-Reported Outcomes.

We reviewed the article titled "The Use of Hyaluronic Acid in Non-surgical Rhinoplasty: A Systematic Review of Complications, Clinical, and Patient-Reported Outcomes" authored by Mortada et al. in Aesthetic Plastic Surgery with considerable interest. This study presents a meticulous systematic review of research examining clinical and patient-reported results in hyaluronic acid (HA) non-surgical rhinoplasty. However, we hold specific reservations about the methodologies employed in the studies encompassed within their analysis. Precise comprehension of the properties of the utilized active substance is essential for any treatment, with standardization being a key factor. Understanding the essential characteristics of the administered HAs is pivotal to establish potential connections between these attributes, outcomes, and complications. Of particular importance in the clinical application of tissue volumization via fillers is rheology, the study of material flow and deformation under stress. Gaining insight into HA's rheological properties is imperative when selecting an appropriate dermal filler for nasal applications. Three pivotal HA properties are viscosity, elasticity, and cohesiveness. While appreciating the authors' contributions, further analysis should account for these factors in their investigation.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 the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Fillers Around the Nose.

OBJECTIVES: The aim of this paper is to review the fillers around the nose. METHODS: The literature search was performed at the PubMed and Proquest Central database of the Kirikkale University Library. RESULTS: Characteristics of an ideal dermal filling material would be low cost, high safety, not causing pain during filling, provoking few sensitivity reactions and being durable. The material should allow reproducible results that are in line with expectation and produce a natural texture, be quick to use, be operation-ready, not cause the patient to need to convalesce and rarely cause complications. Nasal contour remodeling using fillers has several advantages: there is a brief recovery period, a general anesthetic is not needed and ecchymosis does not occur. There are a lot of filler materials, such as collagen, hyaluronic acid, Polymethylmethacrylate with Bovine Collagen, Poly-L-Lactic Acid, calcium hydroxylapatite and expanded polytetrafluoroethylene. CONCLUSION: It is absolutely essential to choose carefully appropriate material and procedure for patients to obtain optimum results.

[Effectiveness and interest of retrobulbar hyaluronidase injections in the treatment of blindness complicating facial hyaluronic acid injections: A literature review]. / Efficacité et intérêt des injections rétrobulbaires de hyaluronidase dans le traitement des cécités compliquant une injection faciale d'acide hyaluronique : revue de la littérature.

INTRODUCTION: Hyaluronic acid injections are becoming increasingly common among both the general public and the medical community, but they are not without risks. The occurrence of blindness, although rare, is a tragic event for both the patient and the practitioner. One of the treatments proposed in the literature is to inject hyaluronidase as close as possible to the site of ischemia, retrobulbarly. The aim of our study is to evaluate the effectiveness and potential benefits of retrobulbar hyaluronidase injections. MATERIALS AND METHODS: A literature review was conducted using the PubMed database. Only articles addressing retrobulbar hyaluronidase injections for the treatment of blindness following hyaluronic acid injections were included. RESULTS: We identified 12 case reports or series, comprising a total of 16 patients. Among these 16 patients, 3 regained their vision. Hyaluronidase was injected between 20minutes and 7days after the onset of the complication, with injected doses ranging from 3×150IU to 3×1500IU. DISCUSSION: Literature reveals only 3 cases of successful treatment out of the 16 reported injections. The time interval before retrobulbar injection, as well as the dose and the experience of the injecting practitioner, may influence the success rate of this treatment. Other treatments, such as intravascular hyaluronidase injections, remain to be explored.

Comparative In Vivo Study of Solid-Type Pure Hyaluronic Acid in Thread Form: Safety and Efficacy Compared to Hyaluronic Acid Filler and Polydioxanone Threads.

INTRODUCTION: Although various products are commonly used for skin rejuvenation, solid-type hyaluronic acid (HA) as an injectable form has not been researched or utilized. This study aimed to demonstrate the safety and efficacy of solid-type HA in thread form, which differs from the conventional gel-type HA commonly used. METHOD: Solid-type HA threads, conventional HA fillers, and polydioxanone (PDO) threads were inserted into the dorsal subcutaneous layer of mice. Photographs were taken on days 0, 1, 3, and 7, and on day 7, the samples were harvested for histological analysis. Inflammatory reactions and detection of collagen were confirmed through tissue staining, and real-time PCR was conducted to quantify collagen synthesis. RESULTS: In the histological analysis, the PDO threads exhibited a greater inflammatory response compared to the HA threads. Masson's trichrome staining revealed a higher degree of collagen synthesis in the HA thread group compared to the HA filler group. While collagen type 1 expression was significantly higher in the PDO thread group than in the HA thread group, the HA thread group showed higher expression levels of collagen type 3. Furthermore, the PDO thread group demonstrated a statistically significant increase in TGF-ß1 compared to the HA group. CONCLUSION: This in vivo study demonstrated the stable application of solid-type pure HA threads and their potential for inducing collagen production, while also yielding a low inflammatory response. The findings highlight the promising applications of solid-type HA in the field of cosmetic dermatology. NO LEVEL ASSIGNED: This journal requires that authors assign a level of evidence to each submission to which Evidence-Based Medicine rankings are applicable. This excludes Review Articles, Book Reviews, and manuscripts that concern Basic Science, Animal Studies, Cadaver Studies, and Experimental Studies. 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 .