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.

Treatment with synchronized radiofrequency and facial muscle stimulation: Histologic analysis of human skin for changes in collagen and elastin fibers.

BACKGROUND: Skin's exposure to intrinsic and extrinsic factors causes age-related changes, leading to a lower amount of dermal collagen and elastin. AIM: This study investigated the effects of a novel facial muscle stimulation technology combined with radiofrequency (RF) heating on dermal collagen and elastin content for the treatment of facial wrinkles and skin laxity. METHODS: The active group subjects (N = 6) received four 20-min facial treatments with simultaneous RF and facial muscle stimulation, once weekly. The control subject (N = 1) was untreated. Skin biopsies obtained at baseline, 1-month and 3-month follow-up were evaluated histologically to determine collagen and elastin fibers content. A group of independent aestheticians evaluated facial skin appearance and wrinkle severity. Patient safety was followed. RESULTS: In the active group, collagen-occupied area reached 11.91 ± 1.80 × 106 µm2 (+25.32%, p < 0.05) and 12.35 ± 1.44 × 105 µm2 (+30.00%, p < 0.05) at 1-month and 3-month follow-up visits. Elastin-occupied area at 1-month and 3-month follow-up was 1.64 ± 0.14 × 105 µm2 (+67.23%, p < 0.05), and 1.99 ± 0.21 × 105 µm2 (+102.80%, p < 0.05). In the control group, there was no significant difference (p > 0.05) in collagen and elastin fibers. Active group wrinkle scores decreased from 5 (moderate, class II) to 3 (mild, class I). All subjects, except the control, improved in appearance posttreatment. No adverse events or side effects occurred. CONCLUSION: Decreased dermal collagen and elastin levels contributes to a gradual decline in skin elasticity, leading to facial wrinkles and unfirm skin. Study results showed noticeable improvement in facial appearance and increased dermal collagen and elastin content subsequent to simultaneous, noninvasive RF, and facial muscle stimulation treatments.

A review of nonsurgical facial rejuvenation and the role of oxymetazoline hydrochloride ophthalmic solution, 0.1% in periorbital revitalization.

BACKGROUND: The demand for nonsurgical facial rejuvenation options is growing, yet the periorbital region remains an area of relative unmet need. This review explores nonsurgical options for facial rejuvenation and the role of oxymetazoline hydrochloride ophthalmic solution, 0.1%, in treating age-related blepharoptosis as part of periorbital rejuvenation. METHODS: Advisors experienced in facial rejuvenation met to discuss existing literature on the upper face and periorbital rejuvenation and the role of oxymetazoline hydrochloride ophthalmic solution, 0.1%, in treating facial aging. RESULTS: An array of nonsurgical options exist to address the signs of aging, including minimally invasive treatments, such as botulinum toxin injections and dermal fillers, and noninvasive therapy, such as lasers, chemical peels, and microdermabrasion. However, treating age-related ptosis in periorbital rejuvenation is mainly addressed surgically. The newly approved α-adrenergic receptor agonist oxymetazoline hydrochloride ophthalmic solution, 0.1%, provides a novel non-interventional approach to blepharoptosis. CONCLUSIONS: Facial rejuvenation is highly sought-after in this post-pandemic era. Each nonsurgical treatment option has its advantages and drawbacks. A patient-centered approach is necessary to select the appropriate procedure considering the patient's concerns and aesthetic sensibilities. The eyes are an area of primary concern for patients, yet surgery is the gold standard for treating ptosis. Oxymetazoline hydrochloride ophthalmic solution, 0.1%, is a safe and effective nonsurgical treatment for blepharoptosis.

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.

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.

Is multiple wavelength diode laser for facial contouring safe?

The multiple wavelength diode laser (MWDL) is a sophisticated device designed to target deeper skin layers by emitting various wavelengths. Its unique feature is the ability to deliver heat to specific depths within the tissue using different wavelengths while simultaneously cooling the skin surface. Recent research by Choi et al. suggests that wavelengths of 755 and 810 nm can induce carbonization in hair follicles, while the 1064 nm wavelength penetrates deeper into tissues. MWDL has been proposed for fat redistribution in aging, but concerns have been raised regarding ocular safety and potential tissue damage, particularly when used near the eyes. Studies have shown ocular injuries during cosmetic laser procedures, emphasizing the need for robust ocular protection and safety protocols. Additionally, there are reports of internal ischemic necrosis and burns, highlighting the importance of precise energy settings and parameter management. While MWDL shows promise, further research and comprehensive guidelines are needed to ensure safe and effective usage in clinical practice.

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.

Disastrous cerebral and ocular vascular complications after cosmetic facial filler injections: a retrospective case series study.

Soft tissue filler injections are among the most popular facial rejuvenation methods. Cerebral infarction and ophthalmic artery occlusion are rare and catastrophic complications, especially when facial cosmetic fillers are injected by inexperienced doctors. Radiologists and plastic surgeons need to increase their awareness of the complications associated with fillers, which allows early diagnosis and intervention to improve patient prognosis. Regarding the mechanism by which vascular occlusion occurs after facial filler injections, a retrograde embolic mechanism is currently the predominant theory. Numerous case reports have been presented regarding complications associated with injections of facial aesthetics. However, the small sample sizes of these studies did not allow for an adequate assessment of the clinical and imaging manifestations based on the location of the occlusion and the type of filler, and detailed elaboration of multiple cerebral infarctions is also lacking. Therefore, this study aimed to investigate the clinical and radiological features of severe cerebral and ocular complications caused by cosmetic facial filler injections. In addition, we discuss the pathogenesis, treatment, and prognosis of these patients. The clinical, computed tomography (CT), magnetic resonance imaging (MRI), and digital subtraction angiography (DSA) findings were described and analysed. Radiological examinations are crucial for demonstrating severe complications, and brain MRI is especially strongly suggested for patients with cosmetic filler-induced vision loss to identify asymptomatic cerebral infarctions. Extreme caution and care should be taken during facial injections by plastic surgeons.

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.

Subcutaneous infection caused by Mycobacterium abscessus following botulinum toxin injections: A case report and literature review.

BACKGROUND: The rapid development of cosmetic injections has led to an increased incidence of nontuberculous mycobacterial (NTM) infection. PATIENTS AND METHODS: Here, we presented a case of cutaneous Mycobacterium abscessus infection subsequent to botulinum toxin injection for treating masseter hypertrophy, and reviewed the literature on skin and soft tissue infections caused by NTM after cosmetic injections. RESULTS AND CONCLUSIONS: The patient underwent surgical excision and regular antibiotic therapy and has had nearly 2 months of follow-up without any signs of infection. The diagnosis and treatment of NTM infection have always been challenging, and further research is needed to standardize and guide the treatment.

Efficacy and safety of combined microneedling therapy for androgenic alopecia: A systematic review and meta-analysis of randomized clinical trials.

OBJECTIVE: To provide dermatologists with more clinical experience in treating androgenetic alopecia, we evaluated the effect and safety of combined microneedling therapy for androgenetic alopecia. METHODS: Studies on combined microneedling for hair loss were comprehensively searched by us in PubMed, Excerpta Medica Database, and the Cochrane Library Database. The literature search spanned the period from 2012 to 2022. Inclusion and exclusion criteria were developed, and the literature was screened according to this criteria. The Cochrane Risk of Bias Tool was used to assess the quality of the studies. The researcher applied Revman 5.3 and Stata 15.1 software to analyze the data after extracting information from the data. RESULTS: Finally, 13 RCTs involving 696 AGA patients were included to compare the clinical effectiveness and adverse events of combined MN therapy with single MN therapy or single drug therapy for AGA. The results of meta-analysis showed as follows: (1) Hair density and diameter changes: The combined MN group was significantly better than any single treatment group, and the differences were statistically significant (MD = 13.36, 95% CI = [8.55, 18.16], Z = 5.45, p < 0.00001; MD = 18.11, 95% CI = [13.70, 22.52], Z = 8.04, p < 0.00001; MD = 13.36, 95% CI = [8.55, 18.16], Z = 5.45, p < 0.00001; MD = 2.50, 95% CI = [0.99, 4.02], Z = 3.23, p = 0.001); (2) the evaluation of satisfaction for efficacy: The doctor satisfaction rating of the combined MN group was significantly higher than that of any single treatment group, with statistical difference (RR = 2.03, 95% CI = [1.62, 2.53], Z = 6.24, p < 0.00001). The difference between the two groups regarding patients satisfaction was not significant (RR = 3.44, 95% CI = [0.67, 17.59], Z = 1.49, p = 0.14). (3) Safety: There was no statistical difference in the incidence of adverse reactions between combination therapy and monotherapy (RR = 0.83, 95% CI = [0.62, 1.12], Z = 1.22, p = 0.22). CONCLUSION: The combined MN group showed statistically significant improvement in hair density and diameter, and good safety compared with monotherapy.

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.

A structured approach with Swiss cheese model to reduce vascular adverse events of filler injections.

BACKGROUND: Filler injection is among the most popular nonsurgical aesthetic procedures worldwide. Though relatively noninvasive, filler injection can lead to severe vascular adverse events. Even though the incidence is rare, it may cause devastating and irreversible outcomes. A Swiss cheese model has been widely applied for risk analysis and management approach in medical field. AIMS: In this review article, we adopt the Swiss cheese model and create a structured approach to prevent severe vascular complications caused by filler injections. METHODS: We reviewed the current literature regarding the knowledge and techniques of preventing vascular adverse events in the filler injection. RESULTS: We propose four structured strategies in this model to reduce the risk of severe vascular adverse events of filler injections, including clinical facial anatomy, safe filler injection principles, real time imaging and auxiliary instruments, and implication of checklist. CONCLUSION: This review provides clinicians a structured approach before and during the filler injection procedure to reduce the risk of vascular adverse events and improve its safety and outcome.