Safety and Duration of Effect of 40U PrabotulinumtoxinA-xvfs for the Treatment of Moderate to Severe Glabellar Lines in Adult Patients: A Phase II, Multi-Center, Randomized, Double Blind, Active-Controlled Trial.

BACKGROUND: Extending the duration of effect of botulinum toxins - by administering doses beyond those of the approved labels - has been an area of increasing interest in the field of aesthetics. OBJECTIVES: To investigate the safety and duration of effect of 40U prabotulinumtoxinA-xvfs (twice the approved dose and concentration) for the treatment of moderate-to-severe glabellar lines. METHODS: 154 adult patients were randomized 1:1:1 to a single treatment of either 40U prabotulinumtoxinA-xvfs (PRA 40, 5 injections of 8U/0.05 mL), or 20U of either prabotulinumtoxinA-xvfs (PRA 20) or onabotulinumtoxinA (ONA 20). Both 20U controls were administered as 5 injections of 4U/0.1 mL. Efficacy and safety were assessed on Days 2, 7 (by phone), 30 and every 30 days thereafter up to 365 days or until the patient had returned to Baseline. The primary effectiveness endpoint was the duration of effect (estimated by Kaplan-Meier analysis), defined as the number of days from Treatment Day (Baseline) to the day that glabellar line severity at maximum frown by investigator assessment returned to the baseline value. RESULTS: Patients had a mean age of 47 years (20-72 years); 69.5% had severe glabellar lines at Baseline. Of the 36 adverse events, 32 (88.9%) were mild and 4 (11.1%) were moderate in severity; none were serious. The median durations of effect were estimated to be 183, 149 and 148 days for PRA 40-, PRA 20- and ONA 20-treated patients, respectively. CONCLUSIONS: In this Phase II pilot study, 40U prabotulinumtoxinA-xvfs was observed to be safe and had a duration of 6 months.

Effectiveness of Volbella (VYC-15L) for Infraorbital Hollowing: Patient-Reported Outcomes From a Prospective, Multicenter, Single-Blind, Randomized, Controlled Study.

BACKGROUND: Infraorbital hollowing can be addressed with hyaluronic acid soft tissue fillers. A prospective, multicenter, evaluator-blinded, randomized, controlled study (NCT03418545) demonstrated the safety and effectiveness of Juvéderm Volbella XC (VYC-15L, Allergan Aesthetics, an AbbVie company, Irvine, CA) in adults seeking correction for infraorbital hollows. OBJECTIVE: The objective of the current analysis was to examine patient-reported outcomes from the clinical study. METHODS: Participants were randomly assigned 3:1 to the VYC-15L treatment group or the no-treatment control group. Outcome measurements included: evaluating investigator (EI)- and participant-assessed Global Aesthetic Improvement Scale (GAIS) scores, as well as participant responses to the FACE-Q Appraisal of Lower Eyelids, questions on treatment satisfaction, the extent to which patients were bothered by dark circles under their eyes, and willingness to recommend treatment to a friend. RESULTS: The modified intent-to-treat population included 135 participants (median age, 47 years; 91.9% female). At Month 3, the majority of VYC-15L-treated participants showed improvements in the EI- and participant-assessed GAIS. The mean change from baseline to Month 3 score (32.7% increase) showed statistically significant improvement (mean [standard deviation], 17.8 [19.8], P < .0001). At Months 3 and 12 posttreatment, most VYC-15L-treated participants reported feeling satisfied with treatment and not feeling moderately or very bothered by dark circles under their eyes, and would recommend treatment to a friend. CONCLUSIONS: The current analysis demonstrated the effectiveness of VYC-15L treatment to reduce infraorbital hollowing and to improve overall satisfaction based on validated patient-reported outcomes. Participant-assessed improvements aligned with EI-assessed outcomes and lasted for 1 year.

Efficacy and Safety of Tapencarium (RZL-012) in Submental Fat Reduction.

BACKGROUND: Tapencarium (RZL-012) (5-(3.6-dibromo-9H-carbazol-9-yl)-N, N, N-trimethylpentan-1-aminium chloride) is a novel injectable synthetic molecule with cytolytic properties, capable of reducing subcutaneous fat volume. OBJECTIVES: The goal of this 3-armed, randomized, double-blind, placebo-controlled phase 2b study was to determine the safety and efficacy of low- and high-dose RZL-012 vs placebo on submental fat (SMF) reduction. METHODS: Patients (n = 151, age 18-65 years) with excess SMF received a single treatment session of RZL-012 or placebo in the submental area, after which they were monitored for 84 days. SMF was assessed at baseline and after dosing with newly developed scales, namely the Clinician Chin Assessment Tool (C-CAT) and Subject Chin Assessment Tool (S-CAT). SMF was also assessed by magnetic resonance imaging (MRI) at screening and on Day 84 after treatment. RESULTS: The proportion of patients who had a 1-grade or 2-grade improvement in C-CAT and/or S-CAT on Day 84 vs baseline was significantly higher in the high-dose RZL-012 group vs the placebo group (P < .002). The relative percentage reduction in MRI-measured SMF volume (Day 84 vs screening) was significantly greater in the high-dose RZL-012 group vs the low-dose RZL-012 or the placebo group (P < .0001). Local injection site reactions were the most common adverse events (AEs). CONCLUSIONS: A single administration of RZL-012 into SMF resulted in significant improvement in submental appearance as assessed by clinicians, patients, and MRI. From a safety perspective, there were no serious AEs and no clinically significant changes in vital signs or laboratory tests over the course of the study.

High Patient Satisfaction for up to 6 Months With OnabotulinumtoxinA Treatment for Upper Facial Lines.

BACKGROUND: OnabotulinumtoxinA safety and efficacy are well established for upper facial lines (UFL), including forehead lines (FHL), glabellar lines (GL), and crow's feet lines (CFL). OBJECTIVE: To investigate the association of onabotulinumtoxinA efficacy with patient-reported psychological impacts and satisfaction in UFL. MATERIALS AND METHODS: A pooled analysis of data from 4 pivotal Phase 3 trials (onabotulinumtoxinA vs placebo in FHL ± GL, FHL + GL ± CFL, CFL, and CFL + GL for ≤180 days) evaluated investigator-assessed ≥1-grade severity improvement on the Allergan Facial Wrinkle Scale at Day 30 (responders). Facial Line Outcomes (FLO-11) Questionnaire, Facial Line Satisfaction Questionnaire (FLSQ), and Subject Assessment of Satisfaction of Appearance (SASA) were used to evaluate responder appearance-related psychological impacts and satisfaction. RESULTS: OnabotulinumtoxinA patients, by primary study focus (FHL, GL, or CFL), totaled 921, 921, and 833, respectively; 786 patients received placebo. Most patients were female, White, and aged 45 to 50 years (median). Through 150 days, >42% FHL, >43% GL, and ≥32% CFL patients were onabotulinumtoxinA responders. Responders reported improvements in appearance-related psychological impacts (FLO-11) and high satisfaction (FLSQ and SASA), sustained through ≥150 days. CONCLUSION: A ≥1-grade improvement with onabotulinumtoxinA is a clinically meaningful outcome in UFL, associated with long-lasting improved patient-reported psychological impacts and high satisfaction.

Safety, Pharmacodynamic Response, and Treatment Satisfaction With OnabotulinumtoxinA 40 U, 60 U, and 80 U in Subjects With Moderate to Severe Dynamic Glabellar Lines.

BACKGROUND: OnabotulinumtoxinA 20 U reduces glabellar line (GL) severity at maximum frown for approximately 3 to 4 months. Small studies have suggested that >20-U doses may increase the efficacy and duration of response for GLs. OBJECTIVES: The aim of this study was to evaluate safety, pharmacodynamic response, and treatment satisfaction with onabotulinumtoxinA doses ≥20 U for GLs. METHODS: This 48-week, double-blind study compared 40, 60, and 80 U onabotulinumtoxinA vs 20 U and placebo in women with moderate or severe dynamic GLs on the Allergan Facial Wrinkle Scale. The following parameters were evaluated: the percentage of subjects with investigator-assessed ≥1-grade Facial Wrinkle Scale improvement from baseline at maximum frown (responders) at Week 24; the estimated median duration of response; the proportion of mostly/very satisfied responders on the Facial Line Satisfaction Questionnaire follow-up Items 1 to 5; and treatment-emergent adverse events. RESULTS: The modified intent-to-treat population (N = 226) had a mean age of 48.0 years, with similar baseline GL severity between treatment groups. Week 24 responder rates were 0% for placebo and 16.0%, 32.0%, 30.6%, and 38.5% for onabotulinumtoxinA 20, 40, 60, and 80 U, with significant (P < 0.05) differences for 40 and 80 U vs 20 U. Median duration of response was longer with all higher doses vs 20 U (≥24.0 vs 19.7 weeks; P < 0.05 vs 20 U at Week 24). Facial Line Satisfaction Questionnaire results indicated high subject satisfaction. The incidence and severity of treatment-emergent adverse events did not exhibit a dose-response effect. CONCLUSIONS: GL treatment with onabotulinumtoxinA doses >20 U demonstrated longer duration of response and higher patient-reported satisfaction vs the on-label 20-U dose with no apparent impact on safety variables.

Comparing Water Absorption of Food and Drug Administration-Approved Hyaluronic Acid Fillers.

BACKGROUND: To compare the water absorption of 12 FDA-approved hyaluronic acid (HA) facial fillers in vitro in conditions relevant to in vivo injection. OBJECTIVE: The goal of this study was to provide long-term insight into an improved, tailored facial rejuvenation approach and to understand sequelae that could affect preoperative surgical planning. METHODS: In 2 experiments, 12 FDA-approved HA fillers were loaded into test tubes with nonpreserved normal saline and then placed in a 94.5°F-96°F environment for 1 month to allow water absorption by passive diffusion. The test tubes were centrifuged so that the hydrated filler could pass to the bottom of the tube. The tubes were centrifuged for 12 minutes at 1,200 revolutions per minute in the first experiment and for 7 minutes in the second experiment. A blue dye was then instilled to demarcate the filler/saline interface. RESULTS: There was variation in the water absorption of different HAs. Low absorption occurred in non-animal-stabilized hyaluronic acid. CONCLUSION: The pattern of water absorption was similar in the 2 experiments. The results inform us about in vivo conditions and provide guidance for filler selection.

Photographic Misrepresentation on Instagram After Facial Cosmetic Surgery: Is Increased Photography Bias Associated With Greater User Engagement?

BACKGROUND: Before-and-after images are commonly used on Instagram (Menlo Park, CA) to advertise aesthetic surgical treatments and are a powerful means of engaging prospective patients. Consistency between before-and-after images accurately demonstrating the postoperative result on Instagram, however, has not been systematically assessed. OBJECTIVES: The aim of this study was to systematically assess facial cosmetic surgery before-and-after photography bias on Instagram. METHODS: The authors queried 19 Instagram facial aesthetic surgery-related hashtags on 3 dates in May 2020. The "top" 9 posts associated with each hashtag (291 posts) were analyzed by 3 plastic surgeons by means of a 5-item rubric quantifying photographic discrepancies between preoperative and postoperative images. Duplicate posts and those that did not include before-and-after images of facial aesthetic surgery procedures were excluded. RESULTS: A total of 3,477,178 posts were queried. Photography conditions were observed to favor visual enhancement of the postoperative result in 282/291 analyzed top posts, with an average bias score of 1.71 [1.01] out of 5. Plastic surgeons accounted for only 27.5% of top posts. Physicians practicing outside their scope of practice accounted for 2.8% of top posts. Accounts with a greater number of followers (P = 0.017) and posts originating from Asia (P = 0.013) were significantly associated with a higher postoperative photography bias score. CONCLUSIONS: Photographic misrepresentation, with photography conditions biased towards enhancing the appearance of the postoperative result, is pervasive on Instagram. This pattern was observed across all physician specialties and raises significant concerns. Accounts with a greater number of followers demonstrated significantly greater postoperative photography bias, suggesting photographic misrepresentation is rewarded by greater user engagement.

Validation of Photonumeric Assessment Scales for Temple Volume Deficit, Infraorbital Hollows, and Chin Retrusion.

BACKGROUND: Assessment scales are valuable tools in aesthetic clinical research and practice. OBJECTIVE: To validate 3 photonumeric scales covering temple volume deficit, infraorbital hollows, and chin retrusion. MATERIALS AND METHODS: Subjects reflecting the whole range of the scales were assessed independently by 3 evaluators at 2 separate occasions. Intraobserver agreement (the ability of each evaluator to assess the same grade for a specific subject at both evaluation occasions) and interobserver agreement (the degree to which evaluators independently provided identical grades for the same subject) were measured by weighted kappa statistics and percent exact agreement. RESULTS: Approximately 70 subjects were included in each scale validation. The predefined success criteria of an intraobserver weighted kappa coefficient of ≥0.6 and an interobserver median pairwise weighted kappa coefficient of ≥0.6 were met for each scale. These results indicate substantial agreement, both between the 2 evaluations, and between the 3 evaluators. CONCLUSION: These scales covering temple volume deficit, infraorbital hollows, and chin retrusion are validated assessment tools, based on live evaluations. Intraobserver agreement (between the 2 evaluations) and interobserver agreement (between the 3 evaluators) were both substantial.

CME: Re-examining the Optimal Use of Neuromodulators and the Changing Landscape: A Consensus Panel Update.

Since initial US Food and Drug Administration approval of botulinum toxin type A (BoNT-A) for aesthetic use in 2002, clinical evidence and experience with BoNT-A and understanding of facial anatomy have greatly increased, leading to rapid advances in treatment planning and implementation. BoNT-A use has expanded from the upper face to the midface, lower face, and neck, so that BoNT-A injection is the most common cosmetic procedure worldwide. Trends in facial aesthetics reflect growing patient diversity with respect to age, gender, and ethnicity. In October 2019, a multidisciplinary panel of 6 experts in minimally invasive injectable procedures in the specialties of dermatology and plastic surgery convened at the 2019 American Society for Dermatologic Surgery (ASDS) meeting in Chicago, IL. Their goal was to discuss recent advances in BoNT-A use in facial aesthetics, including implications of the introduction of new agents in light of an evolving patient population. J Drugs Dermatol. 2020;19(4 Suppl 1):s5-15To receive a CME certificate of participation, you should: •Read the entire publication, including the CME information. •Register or log in at www.paradigmmc.com/822 to complete and submit the online posttest and evaluation. Following online completion of the posttest and evaluation, a certificate of participation will be available for download/printing immediately.Erratum published for this article here.

Re-examining the Optimal Use of Neuromodulators and the Changing Landscape: A Consensus Panel Update

Since initial US Food and Drug Administration approval of botulinum toxin type A (BoNT-A) for aesthetic use in 2002, clinical evidence and experience with BoNT-A and understanding of facial anatomy have greatly increased, leading to rapid advances in treatment planning and implementation. BoNT-A use has expanded from the upper face to the midface, lower face, and neck, so that BoNT-A injection is the most common cosmetic procedure worldwide. Trends in facial aesthetics reflect growing patient diversity with respect to age, gender, and ethnicity. In October 2019, a multidisciplinary panel of 6 experts in minimally invasive injectable procedures in the specialties of dermatology and plastic surgery convened at the 2019 American Society for Dermatologic Surgery (ASDS) meeting in Chicago, IL. Their goal was to discuss recent advances in BoNT-A use in facial aesthetics, including implications of the introduction of new agents in light of an evolving patient population. J Drugs Dermatol. 2020;19(4 Suppl 1):s5-15 To receive a CME certificate of participation, you should: •Read the entire publication, including the CME information. •Register or log in at www.paradigmmc.com/822 to complete and submit the online posttest and evaluation. Following online completion of the posttest and evaluation, a certificate of participation will be available for download/printing immediately.

Erratum: Re-examining the Optimal Use of Neuromodulators and the Changing Landscape: A Consensus Panel Update

Correction to the supplement, Re-examining the Optimal Use of Neuromodulators and the Changing Landscape: A Consensus Panel Update (J Drugs Dermatol. 2020; 19:4 Supp 1).

Final Data from the Condition of Submental Fullness and Treatment Outcomes Registry (CONTOUR)

Perceptions of attractiveness can be negatively affected by submental fullness. Patients seeking to improve their submental contour have a variety of treatment options including surgical procedures, energy-based devices, and injectable treatment. The Condition of Submental Fullness and Treatment Outcomes Registry (CONTOUR) was designed to provide insights into the treatment of submental fat (SMF) in clinical practice. CONTOUR was a prospective observational study that enrolled 1029 adults at 91 sites in the United States and Canada. Patients were followed until treatment completion, discontinuation, or 1 year elapsed from enrollment without treatment. Final data from CONTOUR are reported here. Of the 676 patients who underwent treatment, 570 were treated with ATX-101 (deoxycholic acid injection), 77 with energy-based devices, 23 with surgical liposuction, 5 with laser liposuction, and 9 with other treatments. The majority of treated patients were facial aesthetic treatment naive. A markedly greater percentage of patients with mild or moderate SMF at baseline received treatment with ATX-101 or energy-based devices, whereas the majority of patients undergoing liposuction had severe or extreme SMF. Physicians most frequently cited a preference for a noninvasive/minimally invasive procedure as the reason for choosing either ATX-101 or energy-based devices. The majority of patients were at least partially satisfied with results, regardless of the chosen treatment. Data from CONTOUR indicate that cost is the most important factor in a patient's decision to undergo treatment, that choice of treatment method is most influenced by SMF severity and preference for nonsurgical versus surgical intervention, and that the availability of noninvasive/minimally invasive options has made SMF treatment an attractive first procedure for patients who have not undergone previous facial aesthetic treatments. ClinicalTrials.gov identifier: NCT02438813. J Drugs Dermatol. 2019;18(1):40-48.

Preoperative Skin Conditioning: Extracellular Matrix Clearance and Skin Bed Preparation, A New Paradigm.

This paper introduces the concept of "skin bed preparation" prior to surgical procedures. Following the theory of chronic wound bed preparation and adapting the skin model to one of chronic wound changes related to extrinsic and intrinsic factors, a topical formulation aimed at recycling the extracellular matrix (ECM) from accumulated waste products is evaluated and discussed. The clearance of these products and stimulation of new replacements has the potential to change the regenerative milieu of the skin so that when procedures are carried out, cellular signaling and cross-talk at the dermal level are improved and healing is optimized. By introducing a combination of peptides and other synergistic active agents, a sequence of clearance, regeneration, and remodeling is initiated. This is confirmed and validated by a series of biopsies and clinical studies that demonstrate changes in the ECM as early as 2 to 3 weeks after application. Clinical studies related to resurfacing procedures show accelerated healing and improved symptomatic relief compared with standard of care by preconditioning the skin 2 weeks prior to the procedure. A similar approach is suggested as a potential advantage for invasive surgical procedures based on similar scientific principles elucidated on in the text.

Hyaluronic Acid Gel With (HARRL) and Without Lidocaine (HAJU) for the Treatment of Moderate-to-Severe Nasolabial Folds: A Randomized, Evaluator-Blinded, Phase III Study.

BACKGROUND: Hyaluronic acid (HA) dermal fillers are frequently used to correct or smooth facial wrinkles and folds such as nasolabial folds. OBJECTIVE: To compare the efficacy and safety of 2 HA gels, formulated by 2 different manufacturing processes: XpresHAn Technology (HARRL [with lidocaine]) and Hylacross technology (HAJU-a comparator product without lidocaine). PATIENTS AND METHODS: One hundred seventy subjects with bilateral nasolabial folds rated as moderate or severe, according to the Wrinkle Severity Rating Scale (WSRS), received injections of HARRL in the nasolabial folds on one side of the face and HAJU on the other side. Investigator- and subject-assessed wrinkle severity was measured up to 48 weeks after final injection. RESULTS: HARRL exhibited a similar safety and efficacy profile compared with HAJU. Noninferiority of HARRL was demonstrated at 24 weeks (WSRS mean change from baseline mean difference -0.1 [95% confidence interval: -0.15, 0.01], p = .090). Incidence of adverse events was 40% for both treatments. CONCLUSION: HARRL exhibited a similar safety and efficacy profile compared with HAJU.

Forehead Line Treatment With OnabotulinumtoxinA in Subjects With Forehead and Glabellar Facial Rhytids: A Phase 3 Study.

BACKGROUND: Effacement of horizontal forehead lines (FHL) with onabotulinumtoxinA has not been investigated in prospective Phase 3 studies. OBJECTIVE: To evaluate safety and efficacy of onabotulinumtoxinA treatment of FHL together with glabellar lines (GL). MATERIALS AND METHODS: A 12-month, Phase 3 study randomized subjects with moderate-to-severe FHL and GL to onabotulinumtoxinA 40 U or placebo, distributed between the frontalis (20 U) and glabellar complex (20 U). After Day 180, subjects could receive up to 2 additional open-label onabotulinumtoxinA treatments. Efficacy was assessed using the Facial Wrinkle Scale (FWS) and Facial Line Outcomes questionnaire. RESULTS: The intent-to-treat (ITT) population included 391 subjects, and the modified ITT (mITT) population (subjects with psychological impact) included 254 subjects. After 30 days, onabotulinumtoxinA significantly improved the investigator- and subject-assessed appearance of FHL severity by at least 2 FWS grades in 61.4% of ITT subjects versus 0% of placebo subjects (p < .0001). In the mITT population, 94.8% of onabotulinumtoxinA subjects and 1.7% of placebo subjects achieved investigator- and subject-assessed FWS ratings of none/mild (p = .0003). Patient-reported outcomes were consistent with FWS ratings. OnabotulinumtoxinA was well tolerated. CONCLUSION: OnabotulinumtoxinA 40 U distributed between the frontalis and glabellar complex was safe and effective for treatment of moderate-to-severe FHL.

Prevention and Management of Injection-Related Adverse Effects in Facial Aesthetics: Considerations for ATX-101 (Deoxycholic Acid Injection) Treatment.

ATX-101 (deoxycholic acid injection; Kythera Biopharmaceuticals, Inc. [an affiliate of Allergan plc, Dublin, Ireland]) was approved in 2015 in the United States (Kybella) and Canada (Belkyra) for submental fat reduction. As expected, injection-site reactions such as pain, swelling, and bruising, which were mostly mild or moderate and transient, were common adverse events (AEs) reported in clinical trials. An exploratory Phase 3b study investigating interventions for management of injection-site AEs associated with ATX-101 treatment was recently completed. Based on its results, literature review, and our clinical experiences, we have put forward considerations for management of AEs associated with ATX-101 treatment in clinical practice. Pretreatment with oral ibuprofen and/or acetaminophen an hour before treatment and preinjection with epinephrine-containing buffered lidocaine 15 minutes before treatment can help with management of pain and bruising. Cold application to the treated area before and immediately after the procedure may help to reduce pain (if local anesthetic preinjection is not performed) and swelling. Discontinuing medications/supplements that result in increased anticoagulant or antiplatelet activity 7 to 10 days before ATX-101 treatment, when possible, can reduce the risk of bruising. In summary, injection-site AEs associated with ATX-101 treatment can be effectively managed with commonly used interventions.

Repeated OnabotulinumtoxinA Treatment of Glabellar Lines at Rest Over Three Treatment Cycles.

BACKGROUND: OnabotulinumtoxinA has demonstrated the ability to eliminate mild glabellar lines at rest; however, less is known regarding the effect of repeat treatment on more severe lines at rest. OBJECTIVE: To assess the effect of repeated onabotulinumtoxinA treatment for reduction of glabellar lines at rest. METHODS: Subjects 18 to 75 years old with at least mild glabellar lines at rest, as assessed by the validated Facial Wrinkle Scale (FWS) with photonumeric guide (score ≥ 1), received 3 treatments of 20 U onabotulinumtoxinA 4 months apart (N = 225). "Response" was defined as elimination of glabellar lines at rest (FWS score = 0) at any time point (Days 7, 30, 60, 90, and 120). Effect of treatment cycle on response was analyzed using repeated measures logistic regressions (p < .05). RESULTS: Most subjects were female (85%) and white (88%) (age range: 35-54 years). The likelihood of significant response was as follows: for all subjects combined (odds ratio [OR]: 1.31), for subjects with mild resting lines at baseline (OR: 1.49), and for older women (≥55 years) with mild resting lines at baseline (OR: 2.22). Of all subjects, 76% responded after 1 treatment, and 45% responded in all 3 cycles. CONCLUSION: Subjects repeatedly treated with onabotulinumtoxinA showed progressive improvement in glabellar lines at rest.

Proper Technique for Administration of ATX-101 (Deoxycholic Acid Injection): Insights From an Injection Practicum and Roundtable Discussion.

ATX-101 (deoxycholic acid injection; Kybella in the United States and Belkyra in Canada; Kythera Biopharmaceuticals, Inc., Westlake Village, CA [an affiliate of Allergan plc, Dublin, Ireland]) is the first aesthetic injectable approved for reduction of submental fat. In February 2014, an injection practicum was conducted in the anatomy laboratory at the University of Texas Southwestern Medical Center to explore the proper injection technique for ATX-101 and the importance of its appropriate, safe anatomical placement within the submental area. Subsequent to the injection practicum, a structured roundtable discussion was conducted in which potential implications of the various injection protocols evaluated during the practicum were reviewed. Furthermore, the faculty had the opportunity to provide additional perspectives based on their clinical experience with facial injectables and ATX-101 specifically. In this article, the findings from the injection practicum and roundtable discussion are reported.

Anatomy of the Cervicomental Region: Insights From an Anatomy Laboratory and Roundtable Discussion.

In 2015, ATX-101 (deoxycholic acid injection; Kybella in the United States and Belkyra in Canada; Kythera Biopharmaceuticals, Inc., Westlake Village, CA [an affiliate of Allergan plc, Dublin, Ireland]) was approved as a first-in-class injectable drug for reduction of submental fat. Use of a pharmacologic/injectable therapy within the submental region requires a thorough understanding of cervicomental anatomy to ensure proper injection technique and safe administration. To this end, an anatomy laboratory was conducted to review key external landmarks and important internal anatomic structures that characterize the lower face and anterior neck. External landmarks that define the boundaries of the cervicomental and submental regions were identified including the inferior mandibular border, the anterior border of the sternocleidomastoid muscle, the antegonial notch, the submental crease, the thyroid notch, and the hyoid bone. Relevant internal anatomic structures, including preplatysmal submental fat (the target tissue for ATX-101) and the platysma muscle as well as critical neurovascular and glandular tissues were revealed by dissection. Of particular interest was the marginal mandibular branch of the facial nerve because it typically courses along the inferior mandibular border near the proposed treatment area for ATX-101.

Retro or PeriBulbar Injection Techniques to Reverse Visual Loss After Filler Injections.

BACKGROUND: With the increasing popularity of three dimensional filler treatments, the tip of the injecting needle or cannula is subdermal, often adjacent to the facial vasculature. Inadvertent canalization of these vessels can rarely result in vascular occlusion with consequent blindness or stroke. OBJECTIVE: The goal was to demonstrate a technique of retro or peribulbar injection of hyaluronidase should such an emergency arise if no ophthalmologist was immediately available. The treatment is needed urgently because the retina can only withstand up to 90 minutes of hypoxia. MATERIALS AND METHODS: We present verbal and diagrammatic instructions for this treatment and videos of both the retrobulbar technique (courtesy of Dr. D. Maberley) and peribulbar technique (courtesy of Dr. S. Fagien). RESULTS: None of us have yet used this technique to treat iatrogenic filler induced blindness but we present the information for the benefit of patient safety, given the limited time the retina can survive vascular occlusion. CONCLUSION: Inadvertent canalization of facial vessels can cause embolic occlusion of retinal vasculature because of the anastomotic nature of the facial vasculature and the end artery morphology of the retinal circulation. Embolism from 3-dimensional hyaluronic acid filler use is potentially reversible if hyaluronidase is injected into the adjacent tissue.