Evaluating the Use of IncobotulinumtoxinA in Combination with Calcium Hydroxylapatite with Integral Lidocaine for Improving Chin Profile Projection Aesthetics.

Background: Microgenia resulting from congenital deficiency or aging can significantly affect the facial profile and render it less attractive. This study assessed the effectiveness of treatment with incobotulinumtoxinA (Inco) and calcium hydroxylapatite with integral lidocaine (CaHA[+]) for improving chin profile. Methods: Subjects with a hyperactive mentalis and at least moderate chin retrusion according to the Asian Chin Projection Scale (ACPS) were recruited. At Visit 1, subjects received Inco injection into the mentalis, followed by deep, pre-periosteal injections of CaHA(+) into the pogonion. The primary endpoint was an ACPS improvement of one point at one and six months. Photographs at baseline and each follow-up visit were rated by physicians using the Global Aesthetic Improvement Scale (GAIS). All subjects completed a satisfaction questionnaire. Results: Ten female subjects were recruited. Mean age was 42.5 years and all had moderate-to-severe chin retrusion at baseline (ACPS score ≥2). All subjects demonstrated at least a one-point improvement in ACPS compared with baseline at both the one-month and six-month posttreatment visits. Physician GAIS ratings of subject appearance confirmed that 100 percent of subjects experienced improved chin projection at each follow-up visit compared to baseline. All 10 subjects were pleased with their chin profile after treatment, with 90 percent noting that it was still "very much improved" at six months. Conclusion: Based on our results, combined treatment with CaHA and Inco appears to be effective and well tolerated for improving the facial profile of subjects with chin retrusion. Treatment was associated with a high degree of patient satisfaction and was well tolerated.

The Use of Hyaluronidase in Aesthetic Practice: A Comparative Study of Practitioner Usage in Elective and Emergency Situations.

BACKGROUND: Hyaluronic acids (HAs) continue to be the fillers of choice worldwide and their popularity is growing. Adverse events (AEs) are able to be resolved through the use of hyaluronidase (HYAL). However, routine HYAL use has been at issue due to perceived safety issues. OBJECTIVES: There are currently no guidelines on the use of HYAL in aesthetic practice, leading to variability in storage, preparation, skin testing, and beliefs concerning AEs. This manuscript interrogated the use of this agent in daily practice. METHODS: A 39-question survey concerning HYAL practice was completed by 264 healthcare practitioners: 244 from interrogated databases and 20 from the consensus panel. Answers from those in the database were compared to those of the consensus panel. RESULTS: Compared to the database group, the consensus group was more confident in the preparation of HYAL, kept reconstituted HYAL for longer, and was less likely to skin test for HYAL sensitivity and more likely to treat with HYAL in an emergency, even in those with a wasp or bee sting anaphylactic history. Ninety-two percent of all respondents had never observed an acute reaction to HYAL. Just over 1% of respondents had ever observed anaphylaxis. Five percent of practitioners reported longer-term adverse effects, including 3 respondents who reported loss of deep tissues. Consent before injecting HA for the possible requirement of HYAL was always obtained by 74% of practitioners. CONCLUSIONS: Hyaluronidase would appear to be an essential agent for anyone injecting hyaluronic acid filler. However, there is an absence of evidence-based recommendations with respect to the concentration, dosing, and treatment intervals of HYAL, and these should ideally be available.

An Experimental Model Exhibiting Anterograde and Retrograde Vascular Occlusion of Facial Fillers to Avoid Vision Loss.

Background: Facial filler injection techniques that help decrease the risk of vascular occlusion are an important growing area of study. This study demonstrates a model of injecting fillers into a simulated bifurcated arterial system, using different sized needle gauges at a constant injection pressure. Methods: Three facial fillers were injected into a bifurcated intravenous tubing with continuous irrigation at a constant pressure to simulate a vascular system. Videography was used to observe for retrograde flow through the simulated supratrochlear artery to the bifurcation point, where the filler was redirected by anterograde flow into the branch representing the ophthalmic artery. Results: Filler injection with retrograde flow to the bifurcation occurred with all the 27G needle trials. In comparison, the 30G needle trials were only able to reach the bifurcation point in three of the nine trials. The average time to the bifurcation point with subsequent ophthalmic artery anterograde flow with the 27G and 30G needles were 8.44 (95% confidence interval ±2.06) and 33.33 (95% confidence interval ±16.56) seconds, respectively. Conclusions: Larger 27G needles consistently reached retrograde flow and the bifurcation point faster than 30G needles. This study suggests thinner needles may be less likely to cause retrograde occlusion.

Guidelines for Optimal Patient Outcomes Using Calcium Hydroxylapatite for Jawline Contour.

Background: Calcium hydroxylapatite (CaHA(+); Radiesse(+) [Merz North America, Inc., Raleigh, NC]) is the first FDA-approved injectable filler for subdermal and/or supraperiosteal injection to improve moderate-to-severe loss of jawline contour. CaHA has been recognized in the past for its ability to provide contour and support overlying tissues and utilized for jawline augmentation well before this recent indication; however, with recent FDA approval of CaHA(+) for jawline contour improvement, it is important that clinicians are aware of best practices for patient selection, treatment planning and injection, as well as safety considerations and postprocedure care. Objectives: To provide guidance on best practices for patient assessment and on-label use of CaHA(+) for jawline rejuvenation and augmentation. Methods: As part of a 2-h roundtable discussion, 5 clinicians with expertise in both the use of CaHA(+) and jawline treatment discussed patient selection, CaHA(+) injection technique, and important safety measures, with the purpose of developing guidance to support optimal clinical use. Results: The most common applications of CaHA(+) in the jawline are rejuvenation of the prejowl sulcus, recontouring the jawline, and providing definition to the gonial angle. Improving the gonial angle is of particular interest as it is a procedure sought by patients of all genders and ages. Variations in technique are discussed and case studies are presented. Conclusions: Jawline augmentation is a procedure with wide-ranging appeal for a diverse array of patients. CaHA(+) is an ideal filler for jawline augmentation due to its rheologic properties (high G') and ability to achieve defined contours and angles. Appropriate injection technique permits effective treatment and outcomes associated with high patient satisfaction.

A Randomized Trial to Assess Effectiveness and Safety of a Hyaluronic Acid Filler for Chin Augmentation and Correction of Chin Retrusion.

BACKGROUND: The chin is important for facial appearance, affecting overall balance and harmony of the face. The purpose of this study was to evaluate effectiveness of the hyaluronic acid filler Restylane Defyne for chin augmentation and correction of chin retrusion versus a no-treatment control. METHODS: Male and female subjects, aged 22 years or older, with mild to moderate chin retrusion, were randomized 3:1 to the hyaluronic acid filler Restylane Defyne ( n = 107) or no treatment ( n = 33). Assessments included live, blinded evaluations on a validated chin retrusion scale (Galderma Chin Retrusion Scale), aesthetic improvement (Global Aesthetic Improvement Scale), subject-reported FACE-Q Satisfaction with Chin, and safety follow-up. RESULTS: Galderma Chin Retrusion Scale responder rate (≥1 grade improvement) was higher for the hyaluronic acid filler Restylane Defyne (81 percent) than for control (6 percent) ( p < 0.001) at week 12, and remained higher at week 48 (74 percent versus 11 percent; p < 0.001). Aesthetic improvement rates were high throughout the study as reported by investigators (≥96 percent) and subjects (≥85 percent). Subject satisfaction was higher in the hyaluronic acid filler Restylane Defyne group than in the control group at week 12 ( p < 0.001). In the individual FACE-Q scale items, 87 to 98 percent of subjects were satisfied at week 12. Treatment-related adverse events were mild to moderate. CONCLUSIONS: The hyaluronic acid filler Restylane Defyne was safe and effective for augmentation of the chin region to improve the chin profile and associated with high aesthetic improvement and subject satisfaction. Effectiveness was sustained throughout 48 weeks. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.

PMMA-collagen Gel in Nonsurgical Rhinoplasty Defects: A Methodological Overview and 15-year Experience.

Nonsurgical rhinoplasty (NSR) is an alternative to surgical rhinoplasty for patients who desire correction of mild-to-moderate aesthetic nasal defects but do not wish to undergo surgery due to concern about risks, recovery time, or cost. Although not a surrogate, NSR can be a more accessible and more precise modality for achieving aesthetic goals. Furthermore, for certain types of defects, the precision possible with filler injection versus surgery can make NSR the preferred procedure. In these instances, polymethylmethacrylate (PMMA)-collagen gel is a valuable tool for appropriate candidates due to its permanence and its favorable safety profile when injected appropriately. Methods: Optimal use of PMMA-collagen gel for NSR is predicated on expert-level injector experience and careful patient selection and education. The author draws on over 15 years of experience treating more than 1000 NSR patients with PMMA-collagen gel to provide a discussion of relevant anatomy; methodological overview, including patient selection; and a video describing injection technique of NSR with PMMA-collagen gel. Results: To our knowledge, this is the first published guidance on NSR with permanent filler. In addition to the clinical experience provided, patient images with 10 years of follow-up are included to illustrate the durability of the results and the continued natural appearance of the correction as the treated patients continue to age. Conclusion: In patients with aesthetic nasal deficits treated with filler, where permanent correction is desired, the appropriate use of PMMA-collagen gel is an effective treatment option.

Multimodal Facial Aesthetic Treatment on the Appearance of Aging, Social Confidence, and Psychological Well-being: HARMONY Study.

BACKGROUND: A global approach to facial rejuvenation involves multiple treatment modalities. OBJECTIVES: The aim of this study was to evaluate the impact of multimodal facial aesthetic treatment on self-reported psychological and social outcomes. METHODS: HARMONY, a prospective, multicenter, 4-month study, enrolled patients aged 35 to 65 years to receive on-label treatment with a combination of hyaluronic fillers (VYC-20L, HYC-24L, and/or HYC-24L+), onabotulinumtoxinA, and bimatoprost. Fillers were injected on Day 1, with touch-ups performed on Day 14. OnabotulinumtoxinA was injected at Month 3 into glabellar lines and/or crow's feet lines. Patients applied bimatoprost to eyelashes once daily for 17 weeks. Mean change from baseline on FACE-Q Psychological Well-being and Social Confidence Scales, FACE-Q Aging Appearance Appraisal Scale, and FACE-Q Age Appraisal Visual Analog Scale were assessed. RESULTS: Of 100 patients treated, 93 were evaluated at 4 months posttreatment. Significant improvement vs baseline was observed on the FACE-Q Scales for Psychological Well-being (mean change, -19.9; P < 0.00001), Social Confidence (mean change, -18.2; P < 0.00001), and Aging Appearance (mean change, -28.5; P < 0.0001). On average, patients' self-assessed age was 0.1 years older than actual age at baseline and 4.5 years younger at Month 4 (P < 0.001 vs baseline). Forty-two patients experienced adverse events, all mild to moderate. CONCLUSIONS: Multimodal, full facial aesthetic treatment improves patients' self-reported psychological well-being, social confidence, aging appearance, and perceptions of chronologic age.

Considerations for the Use of Minimally Invasive Aesthetic Procedures for Facial Remodeling in Transgender Individuals.

There is increasing demand among transgender individuals for minimally invasive aesthetic procedures, such as injectable facial fillers and neurotoxins, for facial remodeling and transformation. These procedures may increase transgender individuals' satisfaction with their appearance and allow them to more effectively harmonize their physical appearance with their perception of self. There is currently a lack of information in the medical literature regarding guidelines for the use of these products in transgender patients. In this report, the authors provide experience-based treatment considerations and recommendations for use of minimally invasive facial aesthetic procedures in transgender patients, including case studies illustrating the use of these procedures for both male-to-female and female-to-male transitioning patients. This report highlights the success of minimally invasive methods for assisting transgender patients in achieving their facial remodeling goals. Clinicians play an integral role in the transitioning process for transgender patients, and facial transformation is a key element of this process. When conducted with sensitivity and attention to individual patient goals at varying stages of transition, facial procedures can be of great benefit in enhancing patients' self-perception and overall quality of life.

Aspiration: I don't do it and neither should you.

Aspiration is a safety maneuver prior to filler injection in widespread use throughout the world, despite an absence of scientific evidence to its efficacy. This editorial questions the practice from a logical as well as a scientific point of view.

Nonsurgical Rhinoplasty Using Injectable Fillers: A Safety Review of 2488 Procedures.

Background: Injectable fillers are used worldwide to improve the appearance of the nose by nonsurgical methods. The procedure is not without risks, as blindness and skin necrosis have been reported as a consequence of filler injections in the nose. Objective: To determine an overall adverse event (AE) rate for the nonsurgical rhinoplasty (NSR) procedure and to assess whether previous surgical rhinoplasty increases the odds of an AE. Methods: A retrospective chart review of 2275 patients and 2488 NSR procedures for a 10-year period from a single physician injector was conducted. Results: The overall procedural AE rate was 7.6%, with five cases (0.20%) considered serious (ischemia and necrosis). Previous surgical rhinoplasty patients had a greater AE rate (10.8%) than those patients without previous surgery (7.4%), with a significant odds ratio of 1.51 (95% confidence interval: 1.03-2.18); p = 0.032. Injecting the tip and sidewall of the nose had the highest AE rates for both categories of patients. Conclusions: NSR is a relatively safe procedure with the majority of AEs common injection site reactions. Patients with previous surgical rhinoplasty demonstrated significantly increased odds of an AE potentially due to surgical changes in anatomy.

OnabotulinumtoxinA for Simultaneous Treatment of Upper Facial Lines: Subject-Reported Satisfaction and Impact From a Phase 3 Study.

BACKGROUND: Patient-reported outcomes are increasingly recognized as important measures of treatment benefit. OBJECTIVE: To evaluate subject-reported satisfaction and impact outcomes with onabotulinumtoxinA treatment in neurotoxin-naive adults with forehead lines (FHL), glabellar lines (GL), and crow's feet lines (CFL). METHODS: This Phase 3 study randomized 787 subjects to onabotulinumtoxinA 64 U (FHL 20 U, GL 20 U, and CFL 24 U), 40 U (FHL 20 U, GL 20 U, and CFL placebo), or placebo in double-blind Period 1. Subjects could receive up to 2 additional 64 U treatments in open-label Period 2. Patient-reported outcomes were assessed using the validated Facial Line Satisfaction Questionnaire (FLSQ) and 11-item Facial Line Outcomes (FLO-11) Questionnaire. RESULTS: The proportion of subjects mostly or very satisfied was significantly greater with onabotulinumtoxinA 64 U and 40 U versus placebo (87.9% and 81.4% vs 3.2%; p < .0001). Responder rates on FLSQ Impact Domain, FLO-11 Items 1, 4, 5, and total score were significantly greater with onabotulinumtoxinA versus placebo on Day 30 (p < .0001). Responder rates favoring onabotulinumtoxinA in Period 1 were maintained with repeated onabotulinumtoxinA 64 U treatment in Period 2. CONCLUSION: OnabotulinumtoxinA treatment was associated with high subject satisfaction and significant improvements in appearance-related psychological and emotional impacts.

Pooled Subject-Reported Outcomes From 2 Phase 3 Studies of OnabotulinumtoxinA for Simultaneous Treatment of Forehead and Glabellar Lines.

BACKGROUND: Understanding the subjects' perspective is critical for successfully treating upper facial lines. OBJECTIVE: To understand subjects' self-perception and overall satisfaction after onabotulinumtoxinA treatment for forehead and glabellar lines. METHODS: This analysis pooled data from two 12-month, pivotal phase 3 studies in which toxin-naive subjects received onabotulinumtoxinA 40 U or placebo for treatment of upper facial lines. OnabotulinumtoxinA was administered as 0.1-mL injections at 10 prespecified sites (frontalis: 20 U; glabellar complex: 20 U). Each study used 3 reliable and validated patient-reported outcome instruments to evaluate subject satisfaction and appearance-related psychological effects: the Facial Line Satisfaction Questionnaire (FLSQ), the Facial Line Outcomes (FLO-11) Questionnaire, and the Self-Perception of Age (SPA) Questionnaire. In total, data for 865 subjects (608, onabotulinumtoxinA 40 U; 257, placebo) were analyzed. RESULTS: Treatment with onabotulinumtoxinA 40 U resulted in significant and sustained improvements across all pooled FLO-11 items and FLSQ items compared with placebo. SPA results demonstrated that a significant proportion of subjects in the pooled analysis felt they looked younger after treatment than at baseline (all, p < .0001 vs placebo). CONCLUSION: This study demonstrates a high level of treatment satisfaction and significantly improved appearance-related psychological outcomes among toxin-naive subjects after onabotulinumtoxinA 40 U treatment.

OnabotulinumtoxinA for Treatment of Forehead and Glabellar Lines: Subject-Reported Satisfaction and Impact From a Phase 3 Double-Blind Study.

BACKGROUND: Patient-reported outcomes are important measures of treatment benefit in facial aesthetic medicine. OBJECTIVE: Evaluate prespecified subject-reported satisfaction and impact outcomes with onabotulinumtoxinA treatment of forehead lines (FHL) and glabellar lines (GL). METHODS: The study randomized (3:1) 391 adults with moderate to severe FHL and GL to onabotulinumtoxinA (FHL, 20 U; GL, 20 U) or placebo in double-blind period 1 (days 0-180); subjects could receive up to 2 additional onabotulinumtoxinA treatments in open-label period 2. Patient-reported outcomes were assessed using the validated Facial Line Satisfaction Questionnaire (FLSQ) and the 11-item Facial Line Outcomes (FLO-11) Questionnaire. RESULTS: The proportion of subjects mostly or very satisfied with treatment was significantly greater with onabotulinumtoxinA than with placebo (90.3% vs 1.0%; p < .0001). Responder rates on FLSQ Impact Domain (73.9% vs 18.9%), FLO-11 Item 1 (85.4% vs 3.6%), Item 4 (77.2% vs 11.2%), Item 5 (83.5% vs 7.8%), and total score (86.0% vs 6.9%) were significantly greater with onabotulinumtoxinA than with placebo on Day 30 (p < .0001). Responder rates favoring onabotulinumtoxinA in Period 1 were generally maintained with repeated treatment during Period 2. CONCLUSION: Subjects were highly satisfied with onabotulinumtoxinA treatment and reported significant improvements in appearance-related psychological and emotional impacts of their facial lines.

Safety and Effectiveness of Repeat Treatment With VYC-15L for Lip and Perioral Enhancement: Results From a Prospective Multicenter Study.

BACKGROUND: VYC-15L (Juvéderm Volbella XC) is a nonanimal crosslinked hyaluronic acid (HA) gel with lidocaine. OBJECTIVES: To evaluate safety and effectiveness of repeat treatment with VYC-15L administered 1 year after treatment for lip and perioral enhancement. METHODS: In this prospective multicenter study, 124 subjects with minimal, mild, or moderate lip fullness on the validated 5-point Allergan Lip Fullness Scale (LFS) who received initial/touch-up treatment with VYC-15L received repeat treatment with VYC-15L 1 year after initial treatment. Effectiveness endpoints included LFS responder rates (≥1-point improvement from baseline) and scores on the FACE-Q Satisfaction With Lips and Appraisal of Lip Lines scales at 1 month after repeat treatment. Subjects completed safety diaries for 30 days after repeat treatment. RESULTS: LFS responder rates were 86.2%, 80.3%, and 65.3% at months 1 and 3 and 1 year, respectively, after initial/touch-up treatment. The responder rate improved to 94.3% 1 month after repeat treatment with VYC-15L and required less median volume vs initial/touch-up treatment (1.5 vs 2.6 mL). FACE-Q scores doubled from baseline at 3 months, remained high through 1 year, and doubled from baseline after repeat treatment. At 1 month after repeat treatment, 96.7% and 89.3% of subjects showed improvement over baseline in FACE-Q Satisfaction With Lips and Appraisal of Lip Lines, respectively. Severe injection site responses were less frequent after repeat treatment than initial/touch-up treatment. CONCLUSIONS: Repeat treatment with VYC-15L at 1 year was safe and effective for lip and perioral enhancement, and required less product volume to achieve similar effectiveness to initial/touch-up treatment.

Aesthetic Treatment Positively Impacts Social Perception: Analysis of Subjects From the HARMONY Study.

BACKGROUND: The impact of facial aesthetic treatments not only enhances physical appearance but also psychological well-being. Accordingly, patient-reported outcomes are increasingly utilized as an important measure of treatment success. Observer-reported outcomes are a relevant yet often overlooked measure of treatment benefit. OBJECTIVES: The authors aimed to evaluate the impact of panfacial aesthetic treatment on the perception of an individual in a variety of social contexts. METHODS: A total 2000 men and women (aged 18-65 years) participated in an online study designed to capture the blinded observer's social perception of pretreatment and posttreatment patients who received panfacial aesthetic treatment in the HARMONY study. Perceptions relevant to character traits, age, attractiveness, and social status were evaluated. Observers were divided into 2 groups. Single image respondents (n = 1500) viewed 6 single, randomized patient images (3 pretreatment, 3 posttreatment), and paired image respondents (n = 500) viewed 6 pretreatment and posttreatment image pairs. RESULTS: Single image respondents reported significantly (P < 0.05) higher levels of agreement that posttreatment subjects appeared to possess more positive character traits (eg, healthy and approachable), were more socially adept, younger, more attractive, more successful at attracting others, and possessed a higher social status. Paired image respondents also reported a higher level of agreement for posttreatment images being aligned with positive character traits, representative of a younger and more attractive individual, and one with a higher social status. CONCLUSIONS: The results suggest that the positive impact of minimally invasive panfacial treatment extends beyond enhancing physical appearance and highlights the importance of social perception and observer-reported outcomes in aesthetic medicine.

Impact of Comprehensive, Minimally Invasive, Multimodal Aesthetic Treatment on Satisfaction With Facial Appearance: The HARMONY Study.

BACKGROUND: Individuals seeking aesthetic treatment have concerns regarding multiple facial areas. OBJECTIVES: Assess the aesthetic impact and satisfaction achieved with a multimodal approach to aesthetic treatment using a combination of minimally invasive treatments. METHODS: Prospective, multicenter, rater-blinded, 4-month HARMONY study evaluated patient satisfaction and aesthetic impact of a combination of fillers (VYC-20L, HYC-24L, and HYC-24L+), onabotulinumtoxinA, and bimatoprost. Males and females aged 35 to 65 years received on-label, staged treatment with fillers, as needed per investigator assessment, on day 1, with touch ups allowed on day 14. Bimatoprost was self-administered once daily for 17 weeks. OnabotulinumtoxinA was injected into glabellar lines, crow's feet lines, or both at month 3. Primary effectiveness measure was mean change from baseline on the FACE-Q 10-item Satisfaction with Facial Appearance Overall Scale. RESULTS: Of 100 patients treated, 93 underwent at least the 4-month posttreatment assessment and were assessed for efficacy. The FACE-Q Satisfaction with Facial Appearance Overall Scale total score increased from baseline (41.2) to month 4 (72.9; P < 0.00001; effect size, 2.7). Improvement following multimodal treatment was observed on FACE-Q individual items. Self-perceived age decreased from 0.2 years older than actual age at baseline to 4.6 years younger at month 4. Nearly all patients (99%) rated themselves as improved or much improved on the Global Aesthetic Improvement Scale. Investigator assessments also demonstrated improvement. Mild to moderate adverse events occurred in 42 patients. CONCLUSIONS: Minimally invasive, multimodal treatment resulted in improvements in FACE-Q scores and perceived age, indicating a high degree of patient satisfaction and a younger facial appearance.

Volume correction in the aging hand: role of dermal fillers.

The hands, just like the face, are highly visible parts of the body. They age at a similar rate and demonstrate comparable changes with time, sun damage, and smoking. Loss of volume in the hands exposes underlying tendons, veins, and bony prominences. Rejuvenation of the hands with dermal fillers is a procedure with high patient satisfaction and relatively low risk for complications. This study will review relevant anatomy, injection technique, clinical safety, and efficacy of dermal filler volumization of the aging hand.

Extracellular Matrix Modulation: Optimizing Skin Care and Rejuvenation Procedures.

Normal aging and photoaging of the skin are chronic processes that progress gradually. The extracellular matrix (ECM), constituting over 70% of the skin, is the central hub for repair and regeneration of the skin. As such, the ECM is the area where changes related to photodamage are most evident. Degradation of the ECM with fragmentation of proteins significantly affects cross talk and signaling between cells, the matrix, and its constituents. The accumulation of collagen fragments, amorphous elastin agglutinations, and abnormal cross-linkages between the collagen fragments impedes the ECM from its normal repair and regenerative capacity, which manifests as wrinkled, non-elastic skin. Similar to how the chronic wound healing process requires wound bed preparation before therapeutic intervention, treatment of chronic aging of the skin would likely benefit from a "skin bed preparation" to optimize the outcome of rejuvenation procedures and skin maintenance programs. This involves introducing agents that can combat stress-induced oxidation, proteasome dysfunction, and non-enzymatic cross linkages involved in glycation end products, to collectively modulate this damaged ECM, and upregulate neocollagenesis and elastin production. Agents of particular interest are matrikines, peptides originating from the fragmentation of matrix proteins that exhibit a wide range of biological activities. Peptides of this type (tripeptide and hexapeptide) are incorporated in ALASTIN™ Skin Nectar with TriHex™ technology (ALASTIN Skincare, Inc., Carlsbad, CA), which is designed to target ECM modulation with a goal of optimizing results following invasive and non-invasive dermal rejuvenating procedures.

A Comprehensive Approach to Multimodal Facial Aesthetic Treatment: Injection Techniques and Treatment Characteristics From the HARMONY Study.

BACKGROUND: The HARMONY study is the first clinical trial to assess the impact of a global approach to facial rejuvenation with several minimally invasive modalities, using patient-reported outcome measures. OBJECTIVE: Provide details of this treatment approach and describe investigators' experiences and recommendations based on this study. METHODS: This multicenter, 4-month study evaluated subject satisfaction with and psychological impact of combined treatment with VYC-20L (Juvéderm Voluma XC), HYC-24L (Juvéderm Ultra XC), HYC-24L+ (Juvéderm Ultra Plus XC), onabotulinumtoxinA (Botox), and bimatoprost 0.3% ophthalmic solution (Latisse). Treatment-naive adults with moderate-to-severe facial lines and folds and eyelash hypotrichosis received on-label, staged treatment with fillers. Bimatoprost was self-administered once daily for 17 weeks from day 1. OnabotulinumtoxinA was administered for glabellar lines, crow's feet lines, or both at month 3. RESULTS: Overall, 100 subjects received bimatoprost for eyelash hypotrichosis, 96 received onabotulinumtoxinA for glabellar lines and/or crow's feet lines, and 96 received VYC-20L for midface volume deficit. From 17 to 96 subjects received HYC-24L and/or HYC-24L+ for nasolabial folds, oral commissures, marionette lines, perioral lines, or radial cheek lines. Injections of filler generally progressed from cranial to caudal, with midface injected first. Investigator-reported factors that may have contributed to the potential benefits of this approach include the critical role of the midface in facial aesthetics, use of lower volumes of filler in individual facial areas, and anesthetic effects. CONCLUSION: The investigators' perspectives and experience with the injection pattern, sequencing, volumes, and techniques may provide valuable guidance for a multimodal approach to facial aesthetic treatment.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Repeated OnabotulinumtoxinA Treatments in Subjects With Crow's Feet Lines and Glabellar Lines.

BACKGROUND: This is the third study in a Phase 3 program evaluating onabotulinumtoxinA treatment of crow's feet lines (CFL). OBJECTIVE: To assess the efficacy and safety of repeated onabotulinumtoxinA treatments of CFL alone or with glabellar lines (GL) in subjects with moderate-to-severe CFL and GL (maximum smile). MATERIALS AND METHODS: This 5-month extension of a 7-month study randomized subjects who originally received onabotulinumtoxinA 24 U (CFL only; n = 227) or 44 U (24 U for CFL + 20 U for GL; n = 260) to retreatment with the same dose. Placebo-treated subjects were rerandomized to onabotulinumtoxinA 44 U (n = 101) or placebo (n = 96). Primary efficacy end point (Day 30) was the proportion of subjects who achieved a CFL severity rating of none or mild (maximum smile) on the investigator-assessed Facial Wrinkle Scale (FWS). Additional efficacy end points and adverse events were evaluated. RESULTS: Responder rates (primary end point) were significantly greater in onabotulinumtoxinA-treated groups (24 U: 56.5%; 44 U: 63.6%; placebo: 1.1%; p < .001). Improvements on most patient-reported outcomes (PROs) favored the 44-U group over the 24-U group. Adverse events did not differ among groups; most were mild or moderate. CONCLUSION: Repeated onabotulinumtoxinA treatments significantly reduce CFL severity based on FWS and PROs. Adverse event profiles remain consistent with approved GL labeling.