Background:Utenpanium (RZL-012) (5-(3,6-dibromo-9H-carbazol-9-yl)-N,N,N-trimethylpentan-1-aminium chloride) is a novel injectable cytolytic agent in development for aesthetic and therapeutic indications. This open-label phase 2 study evaluated the safety and efficacy of repeat treatment with RZL-012 for the reduction of submental fat (SMF) in patients previously treated and seeking additional improvement. Methods:Fifteen patients (18-65 y) who had received RZL-012 three to 24 months prior underwent a second treatment to the SMF area and were followed up for more than 84 days. SMF was assessed at baseline and posttreatment using the Clinician Chin Assessment Tool and Subject Chin Assessment Tool. Safety was evaluated through adverse event monitoring, and patient satisfaction was recorded. Results:All patients (15 of 15, 100%) achieved at least a 1-grade improvement on both Clinician Chin Assessment Tool and Subject Chin Assessment Tool relative to the original baseline (before first treatment), and 47% (7 of 15) achieved at least a 2-grade improvement. These outcomes exceeded those observed after initial treatment, in which 67% achieved at least a 1-grade improvement and none achieved at least a 2-grade improvement. Eighty percent of patients reported being "satisfied" or "very satisfied" with treatment outcomes. Adverse events were localized and consistent with prior studies. Conclusions:Repeat treatment with RZL-012 provides additional improvement in SMF appearance with favorable safety and tolerability, supporting its potential utility in patients seeking further aesthetic benefit.
BACKGROUND:Cosmetic surgery procedures in the United States increased by 5% from 2022 to 2023, with notable increase in eyelid surgeries and forehead lifts. These procedures often aim to alter the height and position of the eyebrow and lateral canthus according to cultural preferences. OBJECTIVE:To analyze the impact of eyebrow and lateral canthus elevation on the perception of character traits. METHODS:In this rating-based analysis, 2081 participants with an average age of 26.51 years (8.4 years) [range: 18-68 years] were included. The survey featured an edited unisex face with 2 different modifications for each eye shape and eyebrows, totaling 9 different images. Participants rated the faces on attractiveness, femininity, masculinity, trustworthiness, dominance, threat, and disgust on a 5 points Likert's scale. RESULTS:Increasing eyebrow height reduced attractiveness, femininity, and trustworthiness, and increased masculinity, dominance, threat, and disgust, especially among female respondents. Similar effects were observed with lateral canthus elevation, impacting attractiveness, femininity, masculinity, and trustworthiness negatively, while enhancing dominance, threat, and disgust. Combined eyebrow and lateral canthus adjustments reinforced these trends, highlighting their influence on perceived character traits. Differences in the perception of gender characteristics were observed between the male and female respondents. CONCLUSION:Male and female perceptions differ in assessing character traits following the elevation of the eyebrow and lateral canthus. Females perceive eyebrow and lateral canthal elevation or their combination as reducing femininity, whereas males do not share this perception. Additionally, traits such as attractiveness, trustworthiness, masculinity, dominance, threat, and disgust were rated similarly by males and females. These findings are crucial for preoperative discussions and predicting surgical outcomes.
A 31-year-old female presented with an acute onset of vision loss in the OS. On arrival to the hospital, OS ocular vitals were notable for no light perception vision, relative afferent pupillary defect, elevated intraocular pressure, ophthalmoplegia, and ptosis. Interval history was notable for lip filler injection. Emergent neuroimaging did not demonstrate large vessel occlusion. Ophthalmic artery occlusion resulting in orbital infarction syndrome was suspected. Patient received intravenous solumedrol, verapamil, aspirin, and lateral canthotomy/cantholysis, topical and intravenous antibiotics, and periorbital and orbital injections of hyaluronidase. With improvement in ptosis and extraocular motility, but vision remaining no light perception, the patient was discharged 5 days after presentation. However, a month later, the patient was enucleated due to intractable pain. This is the foremost report of orbital ischemic syndrome in the setting of ophthalmic artery occlusion secondary to hyaluronic acid filler injection to the lip.
Dermal fillers can be used in a wide range of applications. Although the versatility of hyaluronic acid fillers stems from the wide array of available products, for the biostimulatory filler calcium hydroxylapatite (CaHA), dilution can be used to control product volumizing capacity and flow properties, facilitating use for panfacial rejuvenation. Here, the authors share case studies illustrating how CaHA at various dilutions can be used to achieve global aesthetic improvement as part of a multilayered approach to rejuvenation. As part of a continuing medical education activity, the authors treated patients with 1 to 3 sessions of CaHA at various dilutions. Six months after the patients' initial treatments, the authors reconvened to share their experiences and discuss patient results. Select case studies are presented. Though each patient recieved a unique treatment tilored to their own needs, several themes emerged. Although undiluted product can be used to provide deeper volume and structural support in areas like the chin, jawline, and temples, more dilute product (1:1 and 1:2) can be used to provide some volume and/or smooth transitions in the face, whereas hyperdilute CaHA can be used over an even wider surface area in the face, neck, or d & eacute;colletage to tighten skin and improve skin quality (1:3 and 1:4 dilutions). In the cases presented, patients achieved improvement in appearance through treatment with multiple dilutions of CaHA, providing several examples of how CaHA may be used as part of a multilayered approach to facial rejuvenation.
Background: Temple hollowing is characterized by a reduction of volume in the temporal fossa, which can result in a skeletonized look and contribute to an aged appearance. This study aimed to evaluate the safety and effectiveness of VYC-20L injectable gel to improve temple hollowing. Methods: Adults with minimal, moderate, or severe temple hollows were randomized 2:1 to receive VYC-20L or no treatment. Participants were followed up for 13 months for safety and effectiveness assessments. Treatment effectiveness was assessed by blinded evaluating investigators using the validated Allergan Temple Hollowing Scale (ATHS) and the Global Aesthetic Improvement Scale (GAIS), and by participants using GAIS, FACE-Q scales, and patient satisfaction questionnaires. Adverse events and injection-site responses were monitored. Results: At month 3, 80.4% of the treatment group versus 13.5% of the untreated control group achieved a 1-grade improvement or greater in both temples on the ATHS ( P < 0.0001). The ATHS responder rate remained high throughout month 13. The GAIS responder rates at month 3 (responses of improved or much improved) were high in the treatment group, as assessed by the blinded evaluating investigator (83.8%) and participants (92.9%). Furthermore, satisfaction with facial appearance and temples on the FACE-Q questionnaires increased significantly from baseline (both P < 0.0001). Adverse events and injection-site responses were mostly mild and consistent with the known safety profile of fillers. Conclusions: VYC-20L treatment showed favorable safety and effectiveness results in restoring temple volume, with significant aesthetic improvement and high participant satisfaction. Treatment effects lasted for more than a year. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.
OBJECTIVE: To assess the effectiveness and safety of VYC-20L (20 mg/mL hyaluronic acid gel with lidocaine) to improve temple hollowing in adults.
BACKGROUND:RelabotulinumtoxinA (RelaBoNT-A, Galderma, Uppsala, Sweden) is an innovative, ready-to-use liquid botulinum toxin A, produced with PEARL (precipitation-free extraction and activity-preserving refined liquid) manufacturing technology, which yields a potent, complex-free formulation. OBJECTIVES:In the READY-1 study, efficacy and safety outcomes following a single RelaBoNT-A treatment for glabellar line correction were examined. METHODS:Adults with moderate to severe glabellar lines received RelaBoNT-A (50 U) or placebo in a 3:1 randomized, 6-month, phase 3, multicenter, double-blind study. Primary endpoints (examined at Month 1, maximum frown) comprised the composite ≥2-grade response, defined as ≥2-grades improvement from baseline on concurrent investigator (glabellar line investigator live assessment; GL-ILA) and participant (glabellar line subject live assessment; GL-SLA) severity scales (US endpoint), and the investigator-reported responder rate for participants scored as 0 (none) or 1 (mild) (GL-ILA scale only; EU endpoint). Participant satisfaction and treatment-emergent adverse events (TEAEs) were reported. RESULTS:Overall, 297 adults were randomized and treated. Month 1 composite ≥2-grade responder rate was 82.9% (RelaBoNT-A, n = 199) vs 0% (placebo, n = 67; P < .001). Month 1 investigator-reported none or mild responder rate was 96.3% (RelaBoNT-A) vs 4.5% (placebo; P < .001). GL-ILA scores remained higher with RelaBoNT-A (23.6% [none or mild]; 58.1% [≥1-grade improvement]) vs placebo (1.5%; 10.4%, respectively) through Month 6 (P < .001). In the Kaplan-Meier analysis, 75% still showed GL-ILA and GL-SLA improvements from baseline at 169 days (end of study). Participants reported onset of effect from Day 1 (39%) and satisfaction with natural-looking results (96.8%; Month 1). RelaBoNT-A-related TEAEs were low (3.6%) and typically mild. CONCLUSIONS:A single RelaBoNT-A treatment was effective and demonstrated a favorable safety profile. RelaBoNT-A provided significant improvements in glabellar line severity, high satisfaction, rapid onset, and enduring effectiveness throughout the 6-month study period. LEVEL OF EVIDENCE: 1:
Background: Recent research introduced the concept of the "line of convergence" as a guide for injectors to enhance precision and avoid complications when treating the frontalis muscle with toxins. However, currently, no pre-injection ultrasound scanning is employed to increase precision and reduce adverse events when searching for the line of convergence. Objective: To explore the feasibility and practicality of implementing pre-injection ultrasound scanning into aesthetic neuromodulator treatments of the forehead. Methods: The sample of this study consisted of n = 55 volunteers (42 females and 13 males), with a mean age of 42.24 (10.3) years and a mean BMI of 25.07 (4.0) kg/m(2). High-frequency ultrasound imaging was utilized to measure the thickness, length, and contractility of the frontal soft tissue and to determine the precise location of the line of convergence during maximal frontalis muscle contraction. Results: The results revealed that the line of convergence was located at 58.43% (8.7) of the total forehead height above the superior border of the eyebrow cilia without a statistically significant difference between sex, age, or BMI. With frontalis muscle contraction, the forehead shortens in males by 25.90% (6.5), whereas in females it shortens only by 21.74% (5.1), with p < 0.001 for sex differences. Conclusion: This study demonstrated the feasibility and practicality of pre-injection ultrasound scanning for facial aesthetic neuromodulator treatments. Knowing the location of the line of convergence, injectors can determine precisely and on an individual basis where to administer the neuromodulator deep or superficial or when the injection location is at risk to cause eyebrow ptosis.
Objective: To evaluate the safety and efficacy of onabotulinumtoxinA versus placebo for treating platysma prominence (PP).
BACKGROUND:In 2022, the US experienced a significant increase in demand for minimally invasive aesthetic procedures, underscoring its rising acceptance amid an unregulated educational environment for practitioners. The absence of standardized educational pathways and quality control in aesthetic medicine, primarily provided by nonacademic institutions, highlights a critical need for establishing educational standards to ensure practitioner competence and patient safety. OBJECTIVES:The aim of this study was to identify levels of competency for the aesthetic practitioner and necessary achievement milestones during the educational path from novice to expert injector. METHODS:A total of n = 386 international study participants responded to an online questionnaire regarding their experience in aesthetic medicine practice. The questionnaire comprised 58 questions focusing on professional data, the perceived difficulty of injection, and risk for the occurrence of adverse events for specific facial regions in soft tissue filler and toxin injections. RESULTS:Regardless of medical specialty and experience level, averages of 3.85 (1.8) years, 786.4 (2628) filler injections and 549.9 (1543) toxin injections were estimated to progress from novice to advanced injector, while averages of 6.10 (3.7) years, 1842.2 (4793) filler injections, and 1308.5 (3363) toxin injections were estimated to advance from advanced to expert injector. The nose and the perioral region have been ranked as the facial regions where it is most difficult to achieve a perfect aesthetic outcome and with the greatest risk for the occurrence of adverse events for filler and toxin injections, respectively. CONCLUSIONS:In this study we establish an educational framework in aesthetic medicine by defining the progression from novice to competent and expert injector levels, suggesting 4 years of practice and over 790 filler and 550 neuromodulator injections for competence, and at least 6 years with 1840 filler and 1310 neuromodulator injections for expertise. We also identify critical facial regions for targeted treatments by different expertise levels. LEVEL OF EVIDENCE: 4:
Background: Medical aesthetic procedures for facial rejuvenation with laser and energy-based devices (EBDs) are rapidly increasing. The following cases highlight real-life experience using a multi-modality system with various handpieces that combine intense pulsed light (IPL), laser hair removal (808 diode), high-intensity focused ultrasound (HIFU), radiofrequency microneedling (RFM), and thermal radiofrequency (RF) for antiaging and rejuvenation treatment. Laser and RFM treatments may improve skin conditions by inducing cutaneous changes that remodel the skin matrix. Methods: Six physicians who treat patients for skin rejuvenation reported on clinical cases from their practice using a multi-modality system with various handpieces. Results: During the meeting, the advisors discussed 15 cases and agreed to select seven patients with different ages and skin phototypes receiving various treatments for photodamage of the face, neck, and decollete. The advisors discussed why they selected the case, previous treatment, type of treatment, results, and clinical pearls. Conclusion: Sharing best practices in medical aesthetics using combination treatments on a single multi-modality energy-based device such as laser and MRF for facial, neck, and chest skin may support healthcare providers treating patients for skin rejuvenation to improve clinical outcomes.
BackgroundThe increasing number of aesthetic procedures emphasizes the need for effective evaluation methods of aesthetic outcomes. Current practices include the individual practitioners' judgment in conjunction with standardized scales, often relying on the comparison of before-and-after images. This study investigates whether comparative evaluations influence the perception of beauty and aims to enhance the accuracy of aesthetic assessments in clinical and research settings.ObjectiveTo compare the evaluation of attractiveness and gender characteristics of faces in group-based versus individual ratings.MethodsA sample of 727 volunteers (average age of 29.5 years) assessed 40 facial photographs (20 male, 20 female) for attractiveness, masculinity, and femininity using a 5-point Likert scale. Each face was digitally edited to display varying ratios in four lip-related proportions: vertical lip position, lip width, upper lip aesthetics, and lower lip aesthetics. Participants rated these images both in an image series (group-based) and individually.ResultsDifferences in the perception of the most attractive/masculine/feminine ratios for each lip proportion were found in both the group-based and individual ratings. Group ratings exhibited a significant central tendency bias, with a preference for more average outcomes compared to individual ratings, with an average difference of 0.50 versus 1.00. (p=0.033)ConclusionA central tendency bias was noted in evaluations of attractiveness, masculinity and femininity in group-based image presentation, indicating a bias towards more “average” features. Conversely, individual assessments displayed a preference for more pronounced, “non-average” appearances, thereby possibly pointing towards a malleable "intrinsic aesthetic blueprint" shaped by comparative context.
The recent data released by The Aesthetic Society and the American Society of Plastic Surgeons (ASPS) have consolidated the growing and expanding trend of esthetic medicine in the US. According to the 2022 statistics of The Aesthetic Society, a total of 4 594 458 soft tissue filler and neuromodulator procedures were performed by the participating plastic surgery practices across the US; this represents an increase of 13% and 24% respectively when compared to 2021.1 When looking at the 2022 statistics of the ASPS, which collects procedural data performed by ASPS member surgeons, the procedural count was 8 736 591 for neuromodulators and 4 883 419, for soft tissue fillers (excluding lip treatments). This represents an increase of 73% and 70% compared to (prepandemic) 2019.2 These statistics, irrespective of their source, show a clear trend that will most likely continue and expand. This trend also mirrors a shift in societal perceptions in which esthetic interventions have become an omnipresent element of lifestyle and social media presence.3 What was in the past a taboo, is nowadays considered normal, accepted, and even celebrated. Any region of the body or the face can be treated with surgical or minimally invasive procedures utilizing a multitude of different products and techniques. This amount of treatment possibilities demands a certain degree of training and education which should be required of every esthetic practitioner. Knowledge about anatomy, product rheology, product tissue effects, patient assessment, injection techniques, social impact of esthetic procedures, adverse events recognition and management, and facial ultrasound are some skills (among many others) that esthetic practitioners should have acquired prior to introducing a needle or a cannula into a patient. From an injectors' perspective, this is the most correct thing to do to allow for safer and predictable esthetic outcomes following the fundamental principles of the Hippocratic oath. Every patient has the right to be treated to the best knowledge and abilities of the person pressing the plunger, independent of their educational career path (physician or nonphysician). Unfortunately, esthetic education remains unregulated in the US (as it is in many other countries) and is additionally and predominantly practiced in the private sector outside of academic ivory towers. This prompted private institutions, societies, and key opinion leaders to step forward into medical education and pass on their personal experiences and opinions to their esthetic peers. This has resulted in an increase in educational offerings on web portals, social media sites, and in-person courses, which again leaves the esthetic practitioner with a variety of options to choose from. Despite this, no overarching regulatory board or institution offers guidance on the education path of novice injectors to becoming experts in their field. The variability in the educational level of injectors is understandably high, prompting the question of how to guide injectors during their educational journey from novice via competent to expert injectors and how to assure safe treatments for their esthetic patients. Some institutions have taken measures to assure consistency and have, for instance, restricted soft tissue filler treatments of high-risk areas including the glabella, nose, and forehead, intending to prevent inexperienced novice injectors from targeting such facial regions to ultimately avoid the occurrence of adverse events. To date, there is no consensus on the levels of competency of esthetic practitioners when relating to the Dreyfus model of competency, or which milestones need to be achieved during the educational path, nor is an international or national syllabus available guiding the educational journey of esthetic practitioners.4, 5 Additionally, there is no clear definition of skills and competencies establishing a distinction between novice, competent, and expert injectors, which leaves the esthetic community without educational structure or internal quality control. A possible way out of this dilemma and to help patients receive safer and more predictable esthetic treatments would be to initiate a process that would culminate in definition of various levels of competency and what milestones injectors need to achieve during their educational journey. It might also be helpful to establish formal identification of facial regions that are classified as high versus low risk with a goal of ensuring that high-risk areas are treated by only the most highly educated and expert injectors. For example, expert injectors can and should be allowed to treat the nose, glabella, or forehead with soft tissue fillers given their experience with anatomy and adverse event management. In contrast, patient safety would be increased if novice injectors refrained from injecting facial regions of high vascular risk and focused more on lower-risk facial regions like the zygomatic region or the jawline.6, 7 It must be noted that no facial region has zero risk for causing an injection-related visual compromise. Esthetic medical education could benefit from the implementation of core competencies and treatment guidelines as would esthetic patients and the injection community as a whole. However, the path to establishing and implementing such competencies and guidelines is long and difficult. Much research is needed to provide a high level of evidence to design and incorporate levels of competency and to create a standardized educational path to becoming an expert esthetic practitioner. As the discipline of esthetic medicine is constantly growing, the onus is on our community to establish guidelines to ensure best education and highest competency of providers in order to produce best outcomes with the highest level of patient safety. SC is the founder of Cotofana Anatomy Corp., a company specialized in anatomical education. All other authors declared no potential conflicts of interest with respect to the research, authorship, and publication of this article. Authors declare human ethics approval was not needed for this study. Not applicable.
BACKGROUND:The infraorbital hollow (IOH) is a concavity that interrupts the smooth transition between the lower eyelid and the cheek, resulting in a fatigued and aged appearance. Injectable fillers may be utilized to correct volume deficit in the under-eye area, restoring a more youthful appearance. OBJECTIVES:The objective was to demonstrate the effectiveness and safety of a cohesive polydensified matrix (CPM) hyaluronic acid (HA) filler with lidocaine (Belotero Balance (+)) for correcting volume deficit in the IOH. METHODS:Eligible patients with a moderate or severe rating on the Merz Infraorbital Hollow Assessment Scale (MIHAS) were randomized 2:1 to treatment or control. Controls remained untreated until Week 8 and were then treated. Touch-up injections were allowed; retreatment was offered only in the treatment group. Effectiveness was evaluated with the MIHAS. Adverse events were recorded over a 76-week period. RESULTS:The estimated average response rate (≥1 point MIHAS improvement) was 80.6% (95% CI, 71.4-87.4) in treated patients and 1.9% (95% CI, 0.3-10.2) in controls at Week 8. The difference in estimated response rates was 78.7% (95% CI, 66.3-85.6), demonstrating a statistically significant, superior response rate in treated patients compared to untreated controls. A total of 88 of 97 (90.7%) patients who responded to treatment at Week 8 retained improvement 48 weeks after treatment. Use of Belotero Balance (+) in the IOH had a favorable safety profile, with no unexpected adverse events reported. CONCLUSIONS:Belotero Balance (+) is a safe and effective treatment for correcting volume deficit in the IOH.
Growth in the research, innovation, and development of laser and energy-based technologies over the past few decades has led to dramatic increases in treatment options for dermatologic and cosmetic concerns of the periorbital area. We highlight recent treatment options using laser and energy-based devices for the clearance of periocular pigmented lesions, including solar lentigines and nevus of Ota; vascular lesions, including port-wine birthmarks, infantile hemangiomas, superficial telangiectasias, and reticular veins; laser ablation of benign tumors, such as xanthelasma; cosmetic rejuvenation; treatment of infraorbital dark circles and festoons; laser removal of eyebrow and eyeliner tattoos; and device-based treatment of chronic dry eyes.
Background Platysma prominence (PP) refers to the undesirable effects that may occur with platysma muscle contraction. Objective Evaluate safety and efficacy of onabotulinumtoxinA for improving Moderate (Grade 3) to Severe (Grade 4) PP in adults. Methods Participants were randomized 1:1 to receive a total dose of onabotulinumtoxinA 26, 31, or 36 U or placebo on Day 1 and monitored for 120 days. Dosage was administered via superficial intramuscular injections into the platysma muscle based on baseline PP severity. Results At Day 14, 32.3% of onabotulinumtoxinA-treated participants in the intent-to-treat population versus 1.9% who received placebo achieved investigator- and participant-rated Grade 1 or 2 (Minimal or Mild) and ≥2-grade improvement from baseline in PP severity, while 56.9% and 51.7% achieved Grade 1 or 2 on investigator's and participant's assessments, respectively (all P < .0001). OnabotulinumtoxinA-treated participants reported higher satisfaction, less bother from jawline and vertical neck band appearance, and reduced psychosocial impact versus placebo (all P < .0001). Adverse event incidence was similar between onabotulinumtoxinA and placebo. No events of dysphagia or muscular weakness were reported. Limitations A single onabotulinumtoxinA treatment was evaluated. Conclusion OnabotulinumtoxinA showed favorable tolerability and significantly improved PP severity and patient-reported outcomes in participants with moderate-to-severe PP.