Nikolis, Andreas

AbstractBackgroundThe growing popularity of aesthetic procedures involving fillers, biostimulators, and neurotoxins has prompted concerns about patient safety. To address these concerns, a global Safety Task Force (STF) was formed.AimsThe inaugural STF meeting prioritized vascular compromise prevention and management, guiding clinical trial design and materials for future meetings, and collecting data from experts on current safety methods.MethodsThe STF was formed and consisted of 16 experts from nine different countries, with each possessing distinct expertise in various fields related to aesthetic injectables. Current safety data, protocols, knowledge gaps and future research priorities were discussed and voted upon.ResultsThe establishment of a global database for tracking filler‐related AEs was favored by 93% of participants. Discussions revolved around the database's scope, data standardization, and whether non‐medical contributors should be included. Aspiration as a safety technique garnered support from 73% of participants. Approximately 43% of participants incorporate ultrasound in their injections, with divergent opinions on its impact and potential when used as a standard of practice versus in AE management. Most physicians on the task force incorporated cannula use for some of their injections (93%). There were varying perspectives on treatments for vascular adverse events (VAE), the primary causes, and the adoption of new protocols in the field.ConclusionsThe STF meeting underscored the need for a coordinated effort to address complications related to HA fillers, including VAE management and hyaluronidase protocols. Reliable treatment endpoints were evaluated, but improved measurement methods are needed. Future meetings will focus on addressing delayed complications, furthering safety in this field.

Background: Non-surgical rhinoplasty with hyaluronic acid (HA) filler is a three-dimensional reshaping technique that achieves tissue enhancement by placing HA deep to nasal skin. Due to its unique rheology, Restylane® Lyft (HA-L, Galderma, Uppsala, Sweden) may be particularly well-suited for injection rhinoplasty, as it has high gel firmness (G’) for strong structural support with minimal integration propensity. Methods: A prospective clinical trial was conducted to evaluate HA-L use for non-surgical rhinoplasty. Thirty-three females were observed over eight months, using the following schedule: Visit 1 = Baseline/Treatment 1; Visit 2 = Optional touch up (Week 2); Visits 3–6 = Follow-ups (Months 1,3,6,8). The primary endpoint was subject improvement at Month 1 assessed by a blinded evaluator using the Global Aesthetic Improvement Scale (GAIS). Subject satisfaction and adverse events (AEs) were also evaluated. Results: A deep, periosteal injection using a bolus technique and 0.34 cc of HA-L was most often used. Seven cases of positive aspiration occurred in 167 injection points (4.19%), among 6/33 (18.18%) subjects. Based on the GAIS, 100% of subjects met the primary endpoint. Subject satisfaction was maximal at Month 1 (100%) and largely maintained at Month 8 (78.57%). Besides expected injection-related AEs (eg, ecchymosis, erythema), immediate AEs during/following treatment were limited to presyncopal symptoms [5/33 subjects (15.15%)]. Importantly, no cases of ischemia were observed. Subject-reported AEs (eg, swelling, erythema, pain) dissipated within 2 to 7 days. Conclusion: Given the technical nature of this technique, HA-L may be well-suited for injection rhinoplasty, due to its strong safety and efficacy profile. Level of Evidence: Level III: Evidence obtained from well-designed cohort study.

Background: The number of soft-tissue filler injections performed in the United States is constantly increasing and reflects the high demand for enhanced facial and body attractiveness. The objective of the present study was to measure the viscoelastic properties of soft-tissue fillers when subjected to different testing frequencies. The range of tested frequencies represents clinically different facial areas with more [lips (high frequency)] or less [zygomatic arch (low frequency)] soft-tissue movement. Methods: A total of 35 randomly selected hyaluronic acid–based dermal filler products were tested in an independent laboratory for their values of G′, G″, tan δ, and G* at angular frequencies between 0.1 and 100 radian/second. Results: The results of the objective analyses revealed that the viscoelastic properties of all tested products changed between 0.1 and 100 radian/second angular frequency. Changes in G′ ranged from 48.5 to 3116 percent, representing an increase in their initial elastic modulus, whereas changes in G″ ranged from −53.3 percent (i.e., decrease in G″) to 7741 percent (i.e., increase in G″), indicating both an increase and a decrease in their fluidity, respectively. Conclusions: The increase in G′ would indicate the transition from a “softer” to a “harder” filler, and the observed decrease in G″ would indicate an increase in the filler’s “fluidity.” Changes in the frequency of applied shear forces such as those occurring in the medial versus the lateral face will influence the aesthetic outcome of soft-tissue filler injections.

AbstractBackgroundCurrent injection algorithms for treating the glabella rely on a five‐ or seven‐point injection technique with possible medial eyebrow ptosis and lateral eyebrow elevation as undesirable outcomes.ObjectiveThe objective of this study was to investigate the efficacy and safety profile of a refined 3‐point injection technique targeting horizontal and vertical glabellar lines.MethodsA total of n=105 patients (27 males and 78 females) with a mean age of 40.90 ± 9.2 years were investigated. The injection technique relied on targeting the muscular origin of the procerus and the corrugator supercilii muscles exclusively. The time of effect onset and the injection‐related outcome 120 days after the treatment was evaluated using the 5‐point glabellar line severity scale.ResultsThe onset of the neuromodulator effect was on average 3.5 ± 1.5 days. There was no statistically significant difference in the amplitude of movement before or 14 days after the treatment with 2.99 ± 4.4 mm vs. 3.39 ± 3.6 mm (p = 0.149) for the medial head of the eyebrow and with 3.18 ± 4.7 mm vs. 3.33 ± 4.3 mm (p = 0.510) for the lateral head of the eyebrow, respectively.ConclusionIncorporating anatomic concepts into clinical practice for glabellar frown line neuromodulator treatments with the investigated 3‐point injection technique resulted in the absence of adverse events like eyebrow ptosis, upper eyelid ptosis, medial eyebrow ptosis, and lateral frontalis hyperactivity. This technique demonstrated efficacy throughout the 4‐month study period.

Abstract Background The temple has been identified as one of the most compelling facial regions in which to seek aesthetic improvement—both locally and in the entire face—when injecting soft tissue fillers. Objective The objective of this study is to identify influences of age, gender, and body mass index (BMI) on temporal parameters to better understand clinical observations and to identify optimal treatment strategies for treating temporal hollowing. Methods The sample consisted of 28 male and 30 female individuals with a median age of 53 (34) years and a median BMI of 27.00 (6.94) kg/m2. The surface area of temporal skin, the surface area of temporal bones, and the temporal soft tissue volume were measured utilizing postprocessed computed tomography (CT) images via the Hausdorff minimal distance algorithm. Differences between the investigated participants related to age, BMI, and gender were calculated. Results Median skin surface area was greater in males compared with females 5,100.5 (708) mm2 versus 4,208.5 (893) mm2 (p < 0.001) as was the median bone surface area 5,329 (690) mm2 versus 4,477 (888) mm2 (p < 0.001). Males had on average 11.04 mL greater temporal soft tissue volume compared with age and BMI-matched females with p < 0.001. Comparing the volume between premenopausal versus postmenopausal females, the median temporal soft tissue volume was 46.63 mL (11.94) versus 40.32 mL (5.69) (p = 0.014). Conclusion The results of this cross-sectional CT imaging study confirmed previous clinical and anatomical observations and added numerical evidence to those observations for a better clinical integration of the data.

AbstractBackgroundMost injection techniques utilizing hyaluronic acid–based soft tissue fillers have predictable outcomes at the location injected. However, the temporal region has been identified to have aesthetic effects beyond the temple.AimsTo identify and quantify the panfacial aesthetic effects of three different temporal injection techniques.Patients/MethodsThe medical records of nine female and five male Caucasian patients with a mean age of 50.9 ± 11.9 years were retrospectively reviewed for the effects of these techniques: supraperiosteal, interfascial, and subdermal. Panfacial effects were evaluated by the semiquantitative assessment of aesthetic scores for the temple volume, the temporal crest visibility, the lateral orbital rim visibility, the position of the eyebrows, the severity of lateral canthal lines, the midfacial volume, and the contour of the jawline.ResultsThe supraperiosteal injection technique had the greatest influence on improving the temporal volume (25.0%), the temporal crest (33.3%), and the lateral orbital rim visibility (31.0%) scales but had no effects in other facial regions. The interfascial injection technique revealed good effects on improving temporal hollowing (23.3%) but had an even greater effect on the crow's feet (26.8%) and on the position of the eyebrow (33.3%). The subdermal injection technique had its greatest effects in the lower face by improving the contour of the jawline (26.8%) followed by the improvement of the lower cheek fullness scale (14.3%).ConclusionFuture injection algorithms could utilize all three injection techniques together as one multi‐layer injection approach with a tailored proportion of each technique based on the aesthetic needs of the patient.

AbstractBackgroundInjections of hyaluronic acid (HA) for tissue augmentation are one of the most common aesthetic treatments performed worldwide. However, few studies have compared the safety and efficacy of small‐ and large‐particle HA (SP‐HA; LP‐HA).AimTo assess and compare the safety and efficacy of SP‐HA and LP‐HA for the correction of nasolabial folds (NLFs).MethodsA prospective, split‐face, triple‐blind study design was used. Ten female subjects were recruited. Patients underwent treatment at baseline, an optional touch up at Week 2, and a follow‐up visit at Week 4. At weeks 2 and 4, a blinded reviewer assessed the patients using the Global Aesthetic Improvement Scale (GAIS) and Wrinkle Severity Rating Scale (WSRS); and subjects completed the Patient Satisfaction Questionnaire (PSQ). At all visits, 3‐dimensional imagery and ultrasonography of patients’ NLFs were captured. Adverse events (AEs) were evaluated by the Investigator and recorded by subjects in diaries.ResultsThe GAIS response rate, defined as ≥ “improved” from baseline, was between 90 (2 weeks) and 100% (1 month) for SP‐HA and was 100% for LP‐HA, at both visits. Paired‐samples t tests revealed significant differences in the change in WSRS scores between groups, at both visits (P < .01). Differences in the clinical effect and lifting capacity of both products were observed in 3‐dimensional imagery and ultrasonography. Treatment volumes varied, with 61.32% more SP‐HA being required than LP‐HA for achieving a ≥ one‐grade WSRS improvement. There were no severe AEs throughout the trial, nor AEs related to the investigational device.ConclusionsLP‐HA demonstrates better efficacy for correcting bony resorption in the nasal pyriform region.

Abstract Background Glabellar soft tissue filler injections have been shown to be associated with a high risk of causing injection-related visual compromise. Objectives The aim of this study was to identify the course of the superficial branch of the supratrochlear and of the deep branch of the supraorbital artery in relation to the ipsilateral vertical glabellar line and to test whether an artery is located deep to this line. Methods Forty-one healthy volunteers with a mean age of 26.17 [9.6] years and a mean BMI of 23.09 [2.3] kg/m2 were analyzed. Ultrasound imaging was applied to measure the diameters, distance from skin surface, distance between the midline, distance between vertical glabella lines, and the cutaneous projection of the supratrochlear/supraorbital arteries at rest and upon frowning. Results The mean distance between the superficial branch of the supratrochlear artery and the ipsilateral vertical glabellar line was 10.59 [4.0] mm in males and 8.21 [4.0] mm in females, whereas it was 22.38 [5.5] mm for the supraorbital artery in males and 20.73 [5.6] mm in females. Upon frowning, a medial shift in supratrochlear arterial position of 1.63 mm in males and 1.84 mm in females and of 3.9 mm in supraorbital arterial position for both genders was observed. The mean depth of the supratrochlear artery was 3.34 [0.6] mm at rest, whereas the depth of the supraorbital artery was 3.54 [0.8] mm. Conclusions The hypothesis that injecting soft tissue fillers next to the vertical glabellar line is safe because the supratrochlear artery courses deep to the crease should be rejected. Additionally, the glabella and the supraorbital region should be considered as an area of mobile, rather than static, soft tissues.

AbstractObjectiveThe most promising facial region for inducing pan‐facial effects is the temporal region. The temple displays signs of facial aging itself which include temporal volume loss and increased visibility of the temporal crest, the temporal vasculature, the lateral orbital rim, and the upper zygomatic arch. The objective of this article is to provide a detailed review of temple anatomy pertaining to routinely performed temporal injection techniques, their expected esthetic outcomes as well as the intendant advantages, disadvantages, and procedure pearls.Materials and MethodsThis narrative review is based on the clinical experience of the authors treating the temporal region for esthetic purposes. The postulated outcome of each technique was observed during the routine clinical practice of the authors.ResultsThe temporal region is based on a bony platform consisting of the parietal, frontal, sphenoid, and temporal bones. The overlying soft tissues are arranged in layers which contain the temporal neurovascular structures. The temporal soft tissues consist of 10 parallel layers which vary in their thickness depending on age‐related influences. Six different techniques will be addressed, which include subdermal and interfascial techniques for volumizing, low and high supraperiosteal techniques for volumizing, and supraauricular and temporal lifting techniques.ConclusionThis narrative provides a detailed anatomic overview of the temporal region and describes each commonly performed injection technique with respect to anatomy, esthetic outcome, as well as potential pearls and pitfalls. It is hoped that the description contained herein may guide esthetic practitioners toward safer and more natural outcomes when treating the face.

AbstractBackgroundTreating the lower face with neuromodulators and targeting the masseter muscle can reduce masseteric hypertrophy but can also change the facial shape. A novel observation after the treatment of the masseter muscle with incobotulinumtoxin Type A was the increase in temporal volume.AimObjectively assess temporal volume increase following treatment of masseteric hypertrophy using incobotulinumtoxin Type A.MethodsNine female patients with a mean age of 35.11 years ± 9.1 [Asian (11.1%) and Caucasian (88.9%)] were treated with incobotulinumtoxin Type A for masseteric hypertrophy. Masseteric prominence and temporal volume were assessed by two independent raters, and temporal fossa volume was measured via 3‐dimensional volumetric imaging.ResultsIndependent of the neuromodulator injection technique (ie, single‐injection versus multi‐injection), a reduction in masseteric hypertrophy occurred represented by a decrease in the masseter prominence scale. In addition, the treatment resulted in a significant improvement of the temporal volume scale and an increase in the measured volume of the temporal fossa. None of the presented measurements were statistically significantly different between the two utilized injection techniques.ConclusionsThis study supports using a full‐face approach when performing aesthetic treatments. Anatomical concepts can help to guide treatments: the compensatory increase in temporalis function after masseter muscle treatment resulted in an increased in temporal fossa volume. The findings presented herein should not be considered as a new concept for treating the temporal fossa but rather as an additional possibility for increasing the temporal volume.