Self-perception of natural outcome, appearance, and emotional well-being after OnabotulinumtoxinA treatment for upper facial lines: Post hoc analysis across age and gender.

BACKGROUND: OnabotulinumtoxinA (onabotA) is indicated for upper facial lines (UFL). Fear of unnatural-looking outcomes is a frequently reported treatment barrier. AIMS: Examine patient-reported outcomes (PROs) after onabotA treatment for UFL. METHODS: A post hoc analysis was conducted on two 12-month pivotal studies of onabotA for forehead and glabellar lines (20 U each), with/without treatment of crow's feet lines (±24 U). This analysis used PROs from the Facial Line Satisfaction Questionnaire: Items 4 (natural look), 5 (treatment effect), 11 (met expectations), and Impact Domain (appearance and psychological impact). The analysis included 458 neurotoxin-naive adults achieving a ≥2-grade improvement in forehead line (FHL) severity on the Facial Wrinkle Scale at Day 30 (primary endpoint). [Corrections made on 28 December 2023, after first online publication: 'UFL' in the previous sentence has been corrected to 'forehead line (FHL)' in this version.] Data were further stratified into millennials and men. RESULTS: At Day 30, 90.5% of all participants, 94.6% of millennials, and 85.7% of men were satisfied with receiving a natural look. Millennials had higher odds of being satisfied with natural outcomes at Day 30. This measure remained > 80% for all groups throughout the 12 months. Additionally, ≥80% were satisfied with the treatment effect, and >90% reported results met expectations. At Day 30, ≥50% reported positive impacts on self-perceived appearance and psychological well-being, but millennials had higher, and men had lower odds of reporting these improvements. CONCLUSIONS: Participants achieving a ≥2-grade improvement in FHL severity after onabotA reported high satisfaction with natural outcomes and the treatment effect, with improved self-perceived appearance and psychological well-being. [Corrections made on 28 December 2023, after first online publication: 'UFL' in the previous sentence has been corrected to 'FHL' in this version.] These results may help aesthetic providers and patients address fears regarding unnatural results with onabotA.

Neutralizing Antibody Formation with OnabotulinumtoxinA (BOTOX®) Treatment from Global Registration Studies across Multiple Indications: A Meta-Analysis.

Though the formation of neutralizing antibodies (NAbs) during treatment with botulinum neurotoxin is rare, their presence may nonetheless affect the biological activity of botulinum toxin and negatively impact clinical response. The goal of this updated meta-analysis was to evaluate and characterize the rate of NAb formation using an expanded dataset composed of 33 prospective placebo-controlled and open-label clinical trials with nearly 30,000 longitudinal subject records prior to and following onabotulinumtoxinA treatment in 10 therapeutic and aesthetic indications. Total onabotulinumtoxinA doses per treatment ranged from 10 U to 600 U administered in ≤15 treatment cycles. The NAb formation at baseline and post-treatment was tested and examined for impact on clinical safety and efficacy. Overall, 27 of the 5876 evaluable subjects (0.5%) developed NAbs after onabotulinumtoxinA treatment. At study exit, 16 of the 5876 subjects (0.3%) remained NAb positive. Due to the low incidence of NAb formation, no clear relationship was discernable between positive NAb results and gender, indication, dose level, dosing interval, treatment cycles, or the site of injection. Only five subjects who developed NAbs post-treatment were considered secondary nonresponders. Subjects who developed NAbs revealed no other evidence of immunological reactions or clinical disorders. This comprehensive meta-analysis confirms the low NAb formation rate following onabotulinumtoxinA treatment across multiple indications, and its limited clinical impact on treatment safety and efficacy.

Esthetic considerations for treating the patient of European descent: Thriving in diversity international roundtable series.

BACKGROUND: The European esthetic experience is informative for understanding both innovation as well as how to care for patients of various backgrounds and ages. AIMS: To discuss best practices for treating the European population and how these approaches may be applied to patient populations across the globe. PATIENTS/METHODS: In support of clinicians who wish to serve a diverse patient population, a 6-part, international roundtable series focused on diversity in esthetics was conducted from August 24, 2021 to May 16, 2022. In each roundtable, expert clinicians were invited to contribute and share best practices. RESULTS: The results of the fifth roundtable in the series, the European Patient, are described here. Key ideas include the growing number of people over the age of 65 years in Europe and the management of this more mature patient population; the role of functional anatomy in treating patients with both fillers and botulinum toxin; and the role of ultrasound in clinical practice for mapping vasculature. CONCLUSIONS: While there is no typical European face, there is much to be learned from thoughtful consideration of how to best manage more mature patients as well as how to use minimally invasive modalities, such as injectables, efficiently to achieve natural-looking results.

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.

PrabotulinumtoxinA vs OnabotulinumtoxinA for the Treatment of Adult Males With Moderate to Severe Glabellar Lines: Post-hoc Analyses of the Phase III Clinical Study Data.

BACKGROUND: Despite a growing interest among men in cosmetic procedures such as botulinum toxin, comparator clinical trial data in this population are limited. OBJECTIVES: The authors sought to compare the efficacy and safety of prabotulinumtoxinA and onabotulinumtoxinA for the treatment of males with moderate to severe glabellar lines. METHODS: Post-hoc analyses were performed on the subpopulation of male patients treated with either a single dose of 20 U prabotulinumtoxinA (n = 25) or 20 U onabotulinumtoxinA (n = 31) in the EVB-003 Phase III glabellar line clinical study. One key efficacy endpoint was the proportion of responders with a ≥1-point improvement from baseline at maximum frown on the 4-point Glabellar Line Scale. RESULTS: Compared with onabotulinumtoxinA-treated males, the percentages of responders who had a ≥1-point improvement on the Glabellar Line Scale at maximum frown were higher at all postbaseline time points for prabotulinumtoxinA-treated males (P > 0.05 at all visits) by an absolute overall mean difference of 10.1% across all visits. Similar trends were observed for efficacy endpoints based on global aesthetic improvement and subject satisfaction. PrabotulinumtoxinA-treated males had a higher incidence of treatment-related headache and eyelid ptosis. CONCLUSIONS: The percentages of patients who met the definition of a responder were higher at almost all time points examined for prabotulinumtoxinA-treated males. Despite the high level of consistency across all measures, differences between the 2 treatment groups did not reach statistical significance. Further study is warranted to establish if these post-hoc analyses observations are reproducible in a larger male patient population.

PrabotulinumtoxinA for Treatment of Millennials With Moderate to Severe Glabellar Lines: Post Hoc Analyses of the Phase III Clinical Study Data.

BACKGROUND: The use of esthetic products by millennials is increasing, yet published clinical trial data in this population are limited. OBJECTIVE: To compare the efficacy and safety of prabotulinumtoxinA for the treatment of moderate to severe glabellar lines in millennial and nonmillennial patients. METHODS AND MATERIALS: Post hoc analyses were performed on the pooled population of all patients treated with 20U prabotulinumtoxinA in the 3 single-dose Phase III glabellar line clinical studies. Patients were grouped by age: millennials (born 1982-2000) versus nonmillennials (born ≤1981). One key efficacy end point was the proportion of responders with a ≥1-point improvement from baseline at maximum frown on the 4-point Glabellar Line Scale. Adverse events were also summarized. RESULTS: Responder rates among millennials (n = 65) were greater than those of nonmillennials (n = 668) by 7.7% on average across all visits; differences were statistically significant at Day 90. Responder rates at Day 90 were 90.2% and 76.1%, respectively (absolute difference of 14.0%, p = .01). Headache was the most common treatment-related adverse event, occurring in 9.0% and 9.4% of millennials and nonmillennials, respectively. CONCLUSION: A single dose of 20U prabotulinumtoxinA administered for the treatment of glabellar lines was similarly well-tolerated by both millennials and nonmillennials; overall, it was more efficacious in millennials.

Enhanced patient retention after combination vs single modality treatment using hyaluronic acid filler and neuromodulator: A multicenter, retrospective review by The Flame Group.

BACKGROUND: It is believed that combination treatment with both neuromodulators (NM) and hyaluronic acid soft-tissue fillers (HA) results in superior aesthetic results and increased patient satisfaction compared to either treatment alone. AIMS: To determine whether combined treatment with NM and HA leads to greater patient retention than treatment with NM or HA alone. PATIENTS/METHODS: This is a large, multi-center, retrospective review of patient retention rates from 7 aesthetic practices across 5 continents, incorporating over 2600 patients. Patient retention is interpreted as a surrogate marker for overall patient satisfaction. Retention rates were compared at 1, 3, and 5 years for patients who received NM only, HA only, or combination treatment with both NM and HA. RESULTS: Combination therapy significantly increased the probability of retention for each time point (1, 3, and 5 years) compared with NM alone (P < .0001) and HA alone (P < .0001). CONCLUSION: This large multicenter, global retrospective review demonstrates that patients who received combined HA and NM were more likely to be retained in the same practice over many years than those who received either treatment alone.

Safety and Performance of Etermis 3 and 4 in Wrinkles/Folds Treatment and Facial Volume Enhancement: A Prospective, Evaluator-Blinded, Open-Label Study.

BACKGROUND: Facial aging is characterized by increased prominence of nasolabial folds (NLFs), marionette lines, and thinning of the lips. Cross-linked hyaluronic acid injection is a very effective method for the temporary correction of these areas. OBJECTIVE: To confirm the clinical performance and the safety of Etermis 3 (ET3) and/or Etermis 4 (ET4) in the treatment of moderate and severe wrinkles/folds, as well as lip volume enhancement. METHODS: Subjects were treated in at least two facial areas (NLFs, marionette lines, lips). ET3 was used in facial moderate wrinkles while ET4 was used in severe facial skin volume loss. An optional touch-up 1 month after treatment was possible. A blinded investigator assessed improvement on Merz Aesthetic Scales (MAS). Subjects were followed-up for 12 months after the last treatment. RESULTS: In total, 154 healthy subjects were enrolled. The proportion of subjects achieving ≥1 score improvement in MAS after treatment was above 60% for ET4 (Month 6/7: NLFs 94.9% and marionette lines 81.4%, p≤0.0004; Month 3/4: lips 63.0%, p=0.39) and ET3 (Month 6/7: marionette lines 79.4%, p=0.0005; Month 3/4: lips 65.5%, p=0.31). Facial improvement was still visible at Month 12/13 for ET4 (NLFs ≥76.6%, marionette lines ≥61%, lips ≥36%) and ET3 (marionette lines ≥50% and lips ≥21.9%). No treatment-related serious AEs occurred. The most frequent AEs were injection-site reactions. CONCLUSION: Etermis 3 and Etermis 4 demonstrated good clinical performance and safety for NLFs and marionette lines volume enhancement for up to 12 months. Both products can also be used safely to treat lips for volume augmentation.

Expert Consensus on Injection Technique and Area-Specific Recommendations for the Hyaluronic Acid Dermal Filler VYC-12L to Treat Fine Cutaneous Lines.

BACKGROUND: VYC-12L is a hyaluronic acid (HA) injectable gel designed to treat fine cutaneous lines and improve skin quality attributes such as hydration and elasticity. OBJECTIVE: Expert consensus was sought on VYC-12L injection technique and primary treatment target areas. METHODS: A multinational group of aesthetic medicine clinicians (n = 128) attended product training and each identified ~10 patients for VYC-12L. After treating their first and last patients, the clinicians completed a survey on preferred injection methodology/technique, including injection angle, volume, and spacing. An expert panel (n = 12) discussed survey results and their clinical experiences to obtain consensus on VYC-12L technique and appropriate treatment areas. RESULTS: Recommendations included micro-depot injections of VYC-12L into the deep dermis with a 32G ½ inch needle inserted at <45º to the skin, spaced 0.5‒1.0 cm apart, with 0.01‒0.05 mL volume per injection (full-face total volume: ~2 mL). Recommended primary treatment areas were the malar, perioral, neck, and décolletage regions. Injection techniques for different treatment areas/demographic characteristics were similar, with some variability in treatment approach. Patient selection criteria, pre- and post-treatment guidelines, and managing patient expectations are important components of treatment. CONCLUSION: These consensus recommendations may assist clinicians in optimizing the treatment of fine lines with VYC-12L.

VYC-25L Hyaluronic Acid Injectable Gel Is Safe and Effective for Long-Term Restoration and Creation of Volume of the Lower Face.

BACKGROUND: Juvéderm Volux (VYC-25L; Allergan plc) is an injectable hyaluronic acid gel designed to restore and create facial volume. OBJECTIVE: The aim of this study was to evaluate the safety and effectiveness of Volux for chin retrusion over 18 months and after repeat treatment. METHODS: This prospective, single-blind, controlled study enrolled subjects aged ≥18 years with chin retrusion (glabella-subnasale-pogonion facial angle 145°-165°). Subjects were randomized (3:1) to Volux at study onset or 3 months later (control group), and could receive a single repeat treatment during months 18 to 24. Assessments included mean facial-angle change from baseline, Global Aesthetic Improvement Scale (GAIS) responder rates (improved/much improved), improvements in 3 subject-reported FACE-Q scales, and safety. RESULTS: Of 132 enrolled subjects, 119 received initial Volux treatment and 89 received repeat treatment. Mean changes (95% confidence interval) in glabella-subnasale-pogonion angle from baseline for treatment and control groups, respectively, were: 1.15° (0.75°, 1.56°) and 1.16° (0.57°, 1.75°) at month 18, and 3.14° (2.68°, 3.61°) and 2.72° (1.78°, 3.66°) 1 month after repeat treatment. Investigators rated 52.5%/60.0% of treated/control subjects at month 18 and 96.9%/100% after retreatment as GAIS responders; subject-reported rates were 62.0%/64.0% and 93.8%/100%. Durable improvements in Satisfaction with Chin, Satisfaction with Lower Face and Jawline, and Psychological Well-Being were reported in 82.1%, 78.2%, and 60.3% of subjects, respectively, at month 18, and 92.3%, 93.8%, and 67.7% of subjects after retreatment. The safety profile was as expected. CONCLUSIONS: Volux injectable gel is a safe, effective, and durable alternative to surgical treatments for increasing chin projection and jaw volume, and results in high patient satisfaction.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Phase III, Non-Inferiority Study Comparing PrabotulinumtoxinA and OnabotulinumtoxinA for the Treatment of Moderate to Severe Glabellar Lines in Adult Patients.

BACKGROUND: PrabotulinumtoxinA is a 900-kDa botulinum toxin type A produced by Clostridium botulinum. OBJECTIVES: The authors sought to investigate the efficacy and safety of prabotulinumtoxinA compared to onabotulinumtoxinA and placebo for the treatment of glabellar lines. METHODS: This was a 150-day, multicenter, double-blind, controlled, single-dose Phase III study. Adult patients (n = 540) with moderate to severe glabellar lines at maximum frown as assessed by the investigator on the validated 4-point Glabellar Line Scale (0 = no lines, 1 = mild, 2 = moderate, 3 = severe), who also felt that their glabellar lines had an important psychological impact, were enrolled. Patients were randomized 5:5:1 to receive a single treatment (0.1 mL injected into each of 5 glabellar sites) of 20 U prabotulinumtoxinA (n = 245), 20 U onabotulinumtoxinA (n = 246), or placebo (n = 49). The primary efficacy endpoint was the proportion of responders (patients with a Glabellar Line Scale score of 0 or 1 at maximum frown by investigator assessment) on day 30. RESULTS: Responder rates for the primary efficacy endpoint were 87.2%, 82.8%, and 4.2% in the prabotulinumtoxinA, onabotulinumtoxinA, and placebo groups, respectively. The absolute difference between prabotulinumtoxinA and onabotulinumtoxinA groups was 4.4% (95% confidence interval [-1.9, 10.8]). Given that the lower bound of the 95% confidence interval for the difference was less than -10.0%, noninferiority of prabotulinumtoxinA vs onabotulinumtoxinA was concluded. Five patients (3 prabotulinumtoxinA, 1.2%; 1 onabotulinumtoxinA, 0.4%; 1 placebo, 2.0%) experienced serious adverse events, none of which were study drug related. CONCLUSIONS: A single treatment of 20 U prabotulinumtoxinA was safe and effective and noninferior to 20 U onabotulinumtoxinA for the treatment of moderate to severe glabellar lines.

Improvement of Radial Cheek Lines With Hyaluronic Acid-Based Dermal Filler VYC-17.5L: Results of the BEAM Study.

BACKGROUND: Radial cheek lines (RCL) may convey an older, potentially less attractive appearance. OBJECTIVE: To evaluate the effectiveness of hyaluronic acid-based dermal filler VYC-17.5L for correcting RCL. MATERIALS AND METHODS: Fifty-three women (40-65 years) received injections of VYC-17.5L in both cheeks on Day 1 (optional Day 14 touch-up). Effectiveness was evaluated on Day 45 by subject-rated dynamic RCL improvement (Global Aesthetic Improvement Scale [GAIS]; primary end point) and independent, noninjecting investigator-rated GAIS; subject Self-Perception of Age (SPA); subject-assessed satisfaction with and natural look of treatment; and instrument-assessed changes in static and dynamic RCL roughness, amplitude, and texture (secondary end points). Safety assessments included injection site responses (ISRs). RESULTS: On Day 45, 98% of subjects rated RCL as improved or much improved (investigator rated: 95%). Subjects with same or older SPA before treatment (n = 38) perceived themselves as 2.0 and 5.5 average years younger after treatment, respectively. Day 45 mean satisfaction with and natural look of treated areas was 7.9/10 and 7.2/10, respectively. Treatment significantly improved RCL roughness, amplitude, and texture (all p < .001). Most common ISRs were hematoma (35.9%), bruising (30.2%), and irregularities/bumps (22.6%); most ISRs were mild. CONCLUSION: VYC-17.5L effectively corrected dynamic RCL, improved instrument-assessed indicators of skin quality, and resulted in younger age perception.

Retention Rates Among Patients Undergoing Multimodal Facial Rejuvenation Treatment Versus a Single Monotherapy in Cosmetic Dermatology Practices.

BACKGROUND: Facial aging is a multifactorial process. Accordingly, expert opinion has largely been unanimous in that multimodal treatment targeting various aspects of the aging face provides superior results. However, there is a lack of studies exploring patient response. OBJECTIVE: To compare patient retention between triple multimodal facial rejuvenation treatment (neuromodulator, filler, and energy-based therapy) and monotherapy (neuromodulator alone). METHODS: A retrospective, multicenter (the United States, Canada, and Germany) study was performed. Cases were retrieved from July 2015 to June 2016. The study compared patients who had undergone monotherapy (neuromodulator), combined multimodal treatment (neuromodulator, filler, and energy-based therapy on the same day), and sequential multimodal treatment (neuromodulator, filler, and energy-based therapy over a 1-year period). Retention rates were calculated. RESULTS: A total of 509 patients were included: monotherapy (300), sequential multimodal treatment (93), and combined multimodal treatment (116). Patient retention was significantly higher in the combined multimodal treatment group compared with the monotherapy and sequential multimodal treatment groups (p < .001). Subgroup analysis revealed similar trends at all sites. CONCLUSION: Based on retention rates, patients are more likely to return to the clinic when multiple treatment modalities are used during 1 encounter. These data further solidify the importance of multimodal therapy for both the provider and the patient.

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.

Improvements in satisfaction with skin after treatment of facial fine lines with VYC-12 injectable gel: Patient-reported outcomes from a prospective study.

BACKGROUND: VYC-12, a hyaluronic acid injectable gel, is designed to treat fine lines and provides improvements in other skin quality attributes. A prospective study demonstrated the safety and effectiveness of VYC-12 for the improvement of fine lines as measured by changes in skin texture. AIMS: To evaluate patient-reported outcomes in subjects treated intradermally with VYC-12 in the cheeks, forehead, and neck (optional) in the prospective study. METHODS: Subjects received an initial treatment of VYC-12 (N = 131), with a touch-up treatment, if deemed necessary, offered 30 days later, and optional repeat treatment 9 months after initial or touch-up treatment. Subjects completed the FACE-Q Satisfaction With Skin scale and assessed willingness to recommend treatment to a friend at baseline, months 1, 4, 6, and 9, and month 1 after repeat treatment. Subjects also evaluated their return to normal daily social activities. RESULTS: Satisfaction with skin improved from baseline in 90.8% of subjects at month 1, 88.4% at month 4, 83.6% at month 6, 76.4% at month 9, and 91.9% at month 1 after repeat treatment (P < .001, all time points). At least 94% of subjects returned to normal daily social activities one day after treatment (initial, touch-up, or repeat). More than 80% of subjects said they would recommend treatment to a friend at all time points through month 9 (97% at month 1 after repeat treatment). CONCLUSION: Treatment with VYC-12 significantly improved satisfaction with skin in the majority of subjects, with most subjects returning to normal activities 1 day after treatment.

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.

VYC-12 Injectable Gel Is Safe And Effective For Improvement Of Facial Skin Topography: A Prospective Study.

OBJECTIVE: Evaluate safety and effectiveness of VYC-12 (Juvéderm Volite; an injectable crosslinked hyaluronic acid gel designed to improve skin quality attributes such as surface smoothness and hydration) for facial intradermal injection. MATERIALS AND METHODS: In a prospective, single-arm study, subjects with moderate/severe cheek skin roughness per Allergan Skin Roughness Scale (ASRS) received VYC-12 in the cheeks and forehead, and/or neck, with touch-up treatment to correct asymmetry 30 days later and optional repeat treatment 9 months after last treatment. The primary effectiveness measure was ASRS responder rate (percentage of cheeks with ≥1-point improvement from baseline) at month 1. Skin hydration was instrument-assessed. RESULTS: Of 131 subjects treated, 31 (23.7%) received touch-up treatment. ASRS responder rate was 96.2% at month 1, 76.3% at month 4, 34.9% at month 6, and 87.1% after repeat treatment. Responder rate in cheeks with severe baseline roughness was 93.8%, 83.1%, and 52.3% at months 1, 4, and 6, respectively. Skin hydration improved significantly (P<0.01) from baseline at all timepoints through month 9. Injection site responses were as expected. All treatment-related adverse events were mild/moderate. CONCLUSION: VYC-12 safely and effectively improved skin smoothness up to 6 months and hydration lasting 9 months.