RESUMO
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.
Assuntos
Toxinas Botulínicas Tipo A , Fármacos Neuromusculares , Envelhecimento da Pele , Toxinas Botulínicas Tipo A/efeitos adversos , Método Duplo-Cego , Testa , Humanos , Fármacos Neuromusculares/efeitos adversos , Resultado do TratamentoRESUMO
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.
Assuntos
Toxinas Botulínicas Tipo A , Técnicas Cosméticas , Satisfação do Paciente , Envelhecimento da Pele , Feminino , Humanos , Masculino , Toxinas Botulínicas Tipo A/efeitos adversos , Técnicas Cosméticas/psicologia , Testa , Fármacos Neuromusculares/efeitos adversos , Resultado do Tratamento , Ensaios Clínicos Fase III como Assunto , Pessoa de Meia-IdadeRESUMO
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 (nâ =â 25) or 20 U onabotulinumtoxinA (nâ =â 31) in the EVB-003 Phase III glabellar line clinical study. One key efficacy endpoint was the proportion of responders with aâ ≥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 aâ ≥1-point improvement on the Glabellar Line Scale at maximum frown were higher at all postbaseline time points for prabotulinumtoxinA-treated males (Pâ >â 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.
Assuntos
Toxinas Botulínicas Tipo A , Fármacos Neuromusculares , Adulto , Humanos , Masculino , Toxinas Botulínicas Tipo A/efeitos adversos , Método Duplo-Cego , Fármacos Neuromusculares/efeitos adversos , Resultado do TratamentoRESUMO
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.
Assuntos
Técnicas Cosméticas/estatística & dados numéricos , Preenchedores Dérmicos/administração & dosagem , Rejuvenescimento , Retenção nos Cuidados/estatística & dados numéricos , Estimulação Elétrica Nervosa Transcutânea/estatística & dados numéricos , Adulto , Idoso , Idoso de 80 Anos ou mais , Canadá , Terapia Combinada/métodos , Terapia Combinada/estatística & dados numéricos , Face/fisiologia , Feminino , Alemanha , Humanos , Masculino , Pessoa de Meia-Idade , Satisfação do Paciente , Estudos Retrospectivos , Envelhecimento da Pele/efeitos dos fármacos , Envelhecimento da Pele/fisiologia , Resultado do Tratamento , Estados Unidos , Adulto JovemRESUMO
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.
Assuntos
Toxinas Botulínicas Tipo A/uso terapêutico , Técnicas Cosméticas , Testa , Fármacos Neuromusculares/uso terapêutico , Envelhecimento da Pele , Adulto , Idoso , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Medidas de Resultados Relatados pelo Paciente , Satisfação do Paciente , Adulto JovemRESUMO
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.
Assuntos
Bochecha , Técnicas Cosméticas , Preenchedores Dérmicos/administração & dosagem , Ácido Hialurônico/administração & dosagem , Envelhecimento da Pele/efeitos dos fármacos , Adulto , Idoso , Estética , Feminino , França , Humanos , Injeções , Pessoa de Meia-Idade , Satisfação do Paciente , Estudos ProspectivosRESUMO
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.
Assuntos
Toxinas Botulínicas Tipo A/administração & dosagem , Técnicas Cosméticas/psicologia , Testa , Medidas de Resultados Relatados pelo Paciente , Satisfação do Paciente , Autoimagem , Envelhecimento da Pele/efeitos dos fármacos , Adolescente , Adulto , Idoso , Ensaios Clínicos Fase III como Assunto , Feminino , Humanos , Injeções , Masculino , Pessoa de Meia-Idade , Adulto JovemRESUMO
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 agedâ ≥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.
Assuntos
Técnicas Cosméticas , Ácido Hialurônico , Envelhecimento da Pele , Técnicas Cosméticas/efeitos adversos , Face , Humanos , Ácido Hialurônico/efeitos adversos , Satisfação do Paciente , Estudos Prospectivos , Método Simples-Cego , Resultado do TratamentoRESUMO
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.
Assuntos
Toxinas Botulínicas Tipo A , Fármacos Neuromusculares , Envelhecimento da Pele , Adulto , Toxinas Botulínicas Tipo A/efeitos adversos , Método Duplo-Cego , Testa , Humanos , Fármacos Neuromusculares/efeitos adversos , Resultado do TratamentoRESUMO
BACKGROUND: VYC-25L, a hyaluronic acid soft-tissue filler with lidocaine, is designed to restore and create facial volume in the chin and jaw. OBJECTIVE: To evaluate the safety and effectiveness of VYC-25L in subjects with chin retrusion. METHODS: Adults with chin retrusion (145°-165° glabella-subnasale-pogonion facial angle) were randomized (3:1) to receive VYC-25L in the chin/jaw at study onset (treatment group) or 3 months later (control group). Primary effectiveness end point was mean change in facial angle from baseline at Month 3. Safety assessments included injection site responses (ISRs), recorded in a subject diary, and adverse events (AEs). RESULTS: VYC-25L was administered to 119 subjects (treatment group: n = 90; control group: n = 29). Mean change in facial angle from baseline at Month 3 was significantly greater in the treatment versus control group (difference: 2.51°; p < .0001). Effectiveness was also demonstrated by the proportion of subjects with improved/much improved Global Aesthetic Improvement Scale scores and responses on FACE-Q Satisfaction and Psychological Well-Being Scales. Treatment benefit remained evident at Month 12. Common ISRs were firmness (95.8%), tenderness (95.8%), and swelling (91.6%). No serious treatment-related AEs were reported. CONCLUSION: VYC-25L significantly improved glabella-subnasale-pogonion facial angle and was generally safe and well tolerated.
Assuntos
Técnicas Cosméticas/efeitos adversos , Preenchedores Dérmicos/administração & dosagem , Ácido Hialurônico/administração & dosagem , Lidocaína/administração & dosagem , Envelhecimento da Pele/efeitos dos fármacos , Adulto , Idoso , Queixo , Preenchedores Dérmicos/efeitos adversos , Combinação de Medicamentos , Estética , Feminino , Humanos , Ácido Hialurônico/efeitos adversos , Reação no Local da Injeção/epidemiologia , Arcada Osseodentária , Lidocaína/efeitos adversos , Masculino , Pessoa de Meia-Idade , Satisfação do Paciente , Resultado do Tratamento , Adulto JovemRESUMO
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.
Assuntos
Toxinas Botulínicas Tipo A/uso terapêutico , Técnicas Cosméticas , Olho , Testa , Fármacos Neuromusculares/uso terapêutico , Medidas de Resultados Relatados pelo Paciente , Envelhecimento da Pele/efeitos dos fármacos , Adolescente , Adulto , Idoso , Método Duplo-Cego , Estética , Humanos , Pessoa de Meia-Idade , Satisfação do Paciente , Inquéritos e Questionários , Resultado do TratamentoRESUMO
BACKGROUND: Although commonly practiced, simultaneous onabotulinumtoxinA injections to multiple facial areas have not been investigated in prospective studies. OBJECTIVE: Evaluate safety and efficacy of onabotulinumtoxinA for treatment of forehead lines (FHL) distributed between the frontalis (20 U) and glabellar complex (20 U), with or without simultaneous lateral canthal areas (crow's feet lines [CFL], 24 U) treatment. METHODS: Subjects with moderate to severe FHL were randomized (2:2:1) to onabotulinumtoxinA 40 U, onabotulinumtoxinA 64 U, or placebo. After 180 days, subjects could receive up to 2 additional open-label onabotulinumtoxinA 64 U treatments. RESULTS: The intent-to-treat (ITT) population comprised 787 subjects, and the modified ITT (mITT) population (subjects with psychological impact) comprised 568. After 30 days, onabotulinumtoxinA 40 U and 64 U significantly improved investigator- and subject-assessed FHL severity by at least 2 Facial Wrinkle Scale (FWS) grades in 45.6% and 53.0% of ITT subjects, respectively, versus 0.6% receiving placebo (both, p < .0001). Significantly more mITT subjects receiving onabotulinumtoxinA achieved investigator- and subject-assessed FWS ratings of none/mild versus placebo (p < .0001). OnabotulinumtoxinA was well tolerated. CONCLUSION: OnabotulinumtoxinA distributed between the frontalis and glabellar complex, with or without additional CFL injections, was safe and effective for treatment of moderate to severe FHL.
Assuntos
Toxinas Botulínicas Tipo A/uso terapêutico , Técnicas Cosméticas , Face , Fármacos Neuromusculares/uso terapêutico , Envelhecimento da Pele/efeitos dos fármacos , Toxinas Botulínicas Tipo A/administração & dosagem , Método Duplo-Cego , Feminino , Humanos , Injeções , Masculino , Pessoa de Meia-Idade , Fármacos Neuromusculares/administração & dosagem , Resultado do TratamentoRESUMO
BACKGROUND: Infraorbital skin depressions are one of the most troublesome facial areas for aesthetically aware patients. OBJECTIVE: Evaluate effectiveness and safety of Juvéderm Volbella with Lidocaine (VYC-15L; Allergan plc, Dublin, Ireland) for correction of bilateral infraorbital depressions. METHODS: In this 12-month, prospective, uncontrolled, open-label study, subjects aged ≥18 years with infraorbital depressions rated ≥1 on the Allergan Infra-oRbital Scale (AIRS) received injections of VYC-15L with optional touch-up treatment on Day 14. The primary efficacy measure was ≥1 AIRS grade improvement from baseline at month 1. RESULTS: Of 80 subjects initially treated with VYC-15L, 75 (94%) completed the study. All injections were intentionally deep, most using multiple microbolus technique. At 1 month, 99.3% of eyes achieved ≥1 AIRS grade improvement. The responder rate (subjects with ≥1 AIRS grade improvement in both eyes) was 99% at month 1, 92% at month 6, and 54% at month 12. Most injection site reactions (e.g., bruising, redness, irregularities/bumps) were mild and resolved by day 14. Late-onset mild to moderate edema was observed in 11% of eyes at month 6% and 4% of eyes at month 12. CONCLUSION: VYC-15L is effective and safe for the treatment of infraorbital depressions, with effectiveness lasting up to 12 months.
Assuntos
Técnicas Cosméticas , Preenchedores Dérmicos/administração & dosagem , Ácido Hialurônico/administração & dosagem , Lidocaína/administração & dosagem , Adulto , Idoso , Olho , Feminino , Humanos , Injeções , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Adulto JovemRESUMO
BACKGROUND: The eyes are particularly important aesthetic features of the face and revitalization of the infraorbital region has become a focus of aesthetic treatments. Published infraorbital scales to date have limitations in that they have been descriptive, subjective, or have used computer-generated images. Thus, there is an unmet need for a validated scale based on actual images. OBJECTIVE: To develop a practical photonumeric scale that respects the complex anatomy and age-related changes occurring in the orbital area. METHODS AND MATERIALS: The Allergan Infra-oRbital Scale (AIRS) was developed through a multistep process in collaboration with 16 physicians (plastic surgeons, dermatologists, and aesthetic physicians). Scale development involved both online photographs and live assessments of subjects. Interrater and intrarater reliability was assessed using intraclass correlation coefficients (ICCs). RESULTS: The final AIRS showed intrarater and interrater ICCs of 0.78 to 0.86 and 0.91 to 0.98 for live validation and 0.76 to 0.82 and 0.86 to 0.91 for online validation, respectively, demonstrating robust validity. CONCLUSION: The AIRS can be considered a photonumeric scale that accurately describes volume loss in the infraorbital region. It has been validated and is appropriate for use in research or for everyday clinical use for both live and photographic assessment.
Assuntos
Estética , Face/anatomia & histologia , Envelhecimento da Pele/patologia , Adulto , Idoso , Bochecha/anatomia & histologia , Pálpebras/anatomia & histologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Fotografação , Reprodutibilidade dos TestesRESUMO
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.
Assuntos
Toxinas Botulínicas Tipo A , Técnicas Cosméticas , Fármacos Neuromusculares , Envelhecimento da Pele , Adulto , Masculino , Humanos , Toxinas Botulínicas Tipo A/uso terapêutico , Fármacos Neuromusculares/uso terapêutico , Satisfação do Paciente , Método Duplo-Cego , Testa , Autoimagem , Resultado do TratamentoRESUMO
Background: Aesthetic medicine has traditionally focused on addressing perceived problem areas, with lack of long-term planning and engagement. Objectives: This article describes a patient-centric model for nonsurgical aesthetic medical practice, termed the 360° approach to facial aesthetic rejuvenation. Methods: The 360° approach was divided into 4 foundational pillars. Medical literature, the authors' clinical experiences, and results from patient satisfaction surveys were used to support the approach. Results: Pillar 1 describes the development of a complete understanding of the patient, based on the use of active listening principles, to characterize the patient's current aesthetic concerns, lifestyle, medical and treatment history, treatment goals, attitude toward aesthetic treatment, and financial resources. Pillar 2 involves conducting a comprehensive facial assessment in contrast to a feature-specific assessment, considering multiple facial tissues and structures and their interrelationships, thus helping to prevent the unanticipated consequences of narrowly focused treatment. Pillar 3 describes leveraging all available treatments and techniques in the development of an initial treatment plan arising from the facial assessment. Pillar 4 adds a time dimension to treatment planning, working toward the goal of a long-term modifiable treatment timeline, with full patient support and involvement; this is designed to facilitate a durable, sustained relationship between the patient and aesthetic healthcare professional (HCP). Conclusions: Although implementation involves substantial commitment and time, the patient-oriented focus of the 360° approach can help achieve optimal patient outcomes and the development of enduring patient-HCP relationships.
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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.
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Toxinas Botulínicas Tipo A , Técnicas Cosméticas , Humanos , Idoso , Toxinas Botulínicas Tipo A/uso terapêutico , Face , Estética , InjeçõesRESUMO
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.
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Toxinas Botulínicas Tipo A , Fármacos Neuromusculares , Humanos , Toxinas Botulínicas Tipo A/efeitos adversos , Anticorpos Neutralizantes , Estudos Prospectivos , Formação de Anticorpos , Resultado do Tratamento , Fármacos Neuromusculares/uso terapêuticoRESUMO
BACKGROUND: Initial applications of calcium hydroxylapatite (CaHA) focused on filling lines and wrinkles. Facial volumization with CaHA has not been fully explored. OBJECTIVE: The purpose of this large scale, prospective, randomized, controlled, multicenter study was to assess CaHA for cheek volumizing, including physician and patient satisfaction. METHODS: Subjects ( N = 116) were randomized to an immediate treatment group or to an untreated control group (crossed over at 3 months). Patients received CaHA injections in their cheeks, defined as the malar, submalar, zygoma, preauricular, and infraorbital areas. Assessments of quantitative changes in cheek volume using magnetic resonance imaging analysis, qualitative assessments by masked evaluators, and physician and patient satisfaction analyses were also performed, including overall satisfaction with aesthetic results and likelihood to return for future treatments. Safety was assessed across 12 months. RESULTS: Mean total treatment volume (107 patients) was 4.7 mL of CaHA. At all points, physicians reported satisfaction of 75% or more, with 92% satisfaction at 12 months. Most patients also reported being satisfied at all time points, with 80% satisfied at 12 months. No serious adverse events occurred. CONCLUSION: Midface volumizing with CaHA results in high physician and patient satisfaction up to 12 months from treatment.
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Bochecha/cirurgia , Técnicas Cosméticas , Durapatita/uso terapêutico , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Satisfação do Paciente , Estudos Prospectivos , Resultado do TratamentoRESUMO
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.