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BACKGROUND: Cellulite is an aesthetically displeasing rippling or dimpling of the skin, primarily on the buttocks/thighs. A recent study showed a novel acoustic subcision device produced significant short-term (12-week) improvement in the appearance of cellulite after a single rapid acoustic pulse (RAP) treatment. OBJECTIVE: To evaluate the long-term (>52-weeks) efficacy and safety of RAP treatment for improvement in the appearance of cellulite. MATERIALS AND METHODS: In this prospective, multicenter trial, female participants ( n = 42) with severe cellulite were treated with the acoustic subcision device in a single visit. At >52 weeks, blinded board-certified dermatologists assessed efficacy by correctly identifying post-treatment photographs and using a 6-point simplified Cellulite Severity Scale (CSS). Participant satisfaction was also collected. Safety was assessed throughout. RESULTS: The blinded panel correctly identified post-treatment photographs at a rate of 95.2%; 70.4% of participants had a >1-point reduction in the CSS score from baseline (mean reduction of 1.09). All participants (100%) reported improved cellulite appearance. Overall pain during treatment was rated as 2.4 and 0.3 post-treatment (pain scale 0-10). No device or treatment-related adverse events were reported at the >52-week follow-up. CONCLUSION: Rapid acoustic pulse treatment significantly improved the long-term appearance of cellulite and was well-tolerated.
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Celulite , Técnicas Cosméticas , Humanos , Feminino , Satisfação do Paciente , Celulite/cirurgia , Estudos Prospectivos , Nádegas , Coxa da Perna , Acústica , Dor , Resultado do TratamentoRESUMO
BACKGROUND: Cellulite is an aesthetic condition affecting the appearance of skin in certain body regions and is associated with body dissatisfaction, psychosocial stress, and decreased quality of life. Previous studies established the safety and feasibility of a novel, minimally invasive device to identify and release septa responsible for cellulite depressions: targeted verifiable subcision (TVS). OBJECTIVES: The objective of this single-arm, open-label, multicenter study was to evaluate the safety and efficacy of TVS for reducing the appearance of moderate to severe cellulite in adult women. METHODS: Adult women aged 21 to 55 years and a BMIâ <â 30 kg/m2 with moderate or severe cellulite on the buttocks and/or thighs were eligible to enroll at 9 sites. Endpoint data included results from 4 of the postprocedural follow-up visits at 24 hours, 7 days, 30 days, and 90 days. The primary endpoints were a meanâ ≥1 point reduction in the Cellulite Severity Scale at 90 days and no related serious adverse events at 30 days. RESULTS: Seventy-four female participants with a mean BMI of 24.8â ±â 2.7 and age of 41.4â ±â 7.4 years received this single procedure. The mean improvement in Cellulite Severity Scale (Nâ =â 68) was 1.5â ±â 0.9 (Pâ <â 0.0001). There were no device-related serious adverse events at 30 days. CONCLUSIONS: TVS for selectively identifying and verifiably releasing septa responsible for cellulite depressions is an effective and safe means to improve the appearance of moderate to severe cellulite in adult women.
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Celulite , Satisfação do Paciente , Adulto , Feminino , Humanos , Resultado do Tratamento , Celulite/cirurgia , Qualidade de Vida , Nádegas/cirurgia , Coxa da PernaRESUMO
BACKGROUND: Safety and efficacy endpoints for the single-arm, multicenter, open-label pivotal study, CONtrolled Focal Fibrous Band Release Method (CONFFIRM) [NCT04743635] assessing targeted verifiable subcision (TVS) for the treatment of cellulite were met at 3 months postprocedure and have been published. Final, 12-month data describing durability of treatment effect and safety are presented here for the first time. OBJECTIVES: The authors sought to evaluate safety and efficacy out to 12 months of initial treatment for a single TVS procedure performed employing the Avéli device (Revelle Aesthetics, Inc.; Mountain View, CA) to treat cellulite on the buttock and thigh areas of adult females. METHODS: Effectiveness was determined by 3 independent physicians employing the Cellulite Severity Scale and Global Aesthetic Improvement Scale to assess improvement of baseline photographs when compared with 3-, 6- and 12-month posttreatment photographs. Blinded participant-reported outcomes and safety evaluations were also performed at all postprocedure time points. RESULTS: Clinically significant improvement in primary endpoint Cellulite Severity Scale scores were sustained out to 1 year, improving by 1.50 (P < .0001) at 3 months, 1.54 points at 6 months, and 1.48 points at 12 months. Adverse events were mild and mostly resolved by the 12-month visit. CONCLUSIONS: A single TVS treatment has durable efficacy and safety in reducing cellulite on the buttocks and thighs of women with moderate to severe cellulite out to 12 months posttreatment.
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Celulite , Técnicas Cosméticas , Adulto , Humanos , Feminino , Satisfação do Paciente , Técnicas Cosméticas/efeitos adversos , Celulite/cirurgia , Coxa da Perna , Nádegas/cirurgiaRESUMO
INTRODUCTION AND OBJECTIVES: Surface depressions and skin laxity together play a role in the appearance of cellulite. Cellulite depressions can be improved through disruption of the subcutaneous fibrous structures. Some currently utilized approaches accomplish this through invasive techniques requiring local anesthesia and potential down time. Skin laxity can exacerbate the appearance of cellulite, however current invasive approaches do little to improve skin laxity. The objective of this study was to evaluate a noninvasive approach to improving both cellulite depressions and skin laxity through the use of rapid acoustic pulses (acoustic subcision). Safety, efficacy, tolerability, and participant satisfaction results were measured. METHODS: Women (n = 56) with moderate to severe cellulite were treated in a single acoustic subcision treatment session without anesthesia. Posttreatment adverse events (AEs) and tolerability were recorded. At 12-weeks cellulite outcomes were assessed using a 6-point simplified Cellulite Severity Scale (CSS), Global Aesthetic Improvement Scale (GAIS), and a participant satisfaction questionnaire. Additionally, laxity improvement was measured using a 4-point Laxity Score (LS) and GAIS. RESULTS: Improvement in cellulite appearance measured at 12-weeks showed that participants (n = 56) had a mean CSS reduction of 1.01 (a 29.5% reduction from baseline). The posttreatment photograph was correctly identified by blinded independent reviewers from randomized pairs of pre/posttreatment photographs for 96.4% of participants. Cellulite was graded as improved, much improved or very much improved using the GAIS at 90.9% of treated locations. Finally, 92.9% of participants reported positive satisfaction responses. Scoring for improvement in skin laxity appearance at 12-weeks showed a mean LS reduction of 0.57 (a 27.9% reduction from baseline). GAIS for laxity was graded as improved, much improved or very much improved in 67.3% of treated areas. No unexpected or serious AEs were noted at treatment or follow-up. Overall average pain score during treatment was 2.4 (0-10 pain scale) and 0.3 immediately posttreatment. CONCLUSION: A single noninvasive acoustic subcision session can safely provide meaningful improvement in the appearance of cellulite in terms of depressions, as well as skin laxity, with minimal treatment pain and no posttreatment down time. Further improvement in appearance is expected with multiple treatments over time. Additional trials to verify this are planned.
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Celulite , Técnicas Cosméticas , Acústica , Nádegas , Feminino , Humanos , Satisfação do Paciente , Coxa da Perna , Resultado do TratamentoRESUMO
BACKGROUND: Cellulite is the dimpled appearance of skin that commonly occurs on the buttocks and thighs of postpubertal women. Cellulite can be emotionally distressing, causing many individuals to seek medical attention. A previous first-in-human study established the safety and feasibility of a novel minimally invasive method for selectively identifying and manually releasing the specific septa responsible for causing cellulite depressions in a precise manner. OBJECTIVES: The objective of this open-label, multicenter study was to evaluate the safety, efficacy, and feasibility of this method for reducing the appearance of moderate and severe cellulite in adult women. METHODS: Female patients (nâ =â 20) 21 to 55 years old with a BMIâ ≤â 35 kg/m2 with moderate or severe cellulite on the buttocks and/or thighs were enrolled at 4 clinics. Patients were evaluated on posttreatment Days 7, 30, 120, and 180. The primary endpoint was a meanâ ≥1-point reduction in the Cellulite Severity Scale at 180 days. RESULTS: Most patients (nâ =â 18, 95%) achieved the primary endpoint. All patients (nâ =â 19, 100%) were rated as much improved or very much improved in Cellulite Severity Scale scores. Adverse events and investigator findings were mild and transient, and none were unexpected. CONCLUSIONS: A novel method for selectively identifying and manually releasing the specific septa responsible for causing cellulite depressions in a precise manner is a safe and effective means for improving the appearance of moderate and severe cellulite in adult women with a wide variety of skin types.
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Celulite , Técnicas Cosméticas , Adulto , Nádegas/cirurgia , Celulite/cirurgia , Técnicas Cosméticas/efeitos adversos , Feminino , Humanos , Pessoa de Meia-Idade , Coxa da Perna , Resultado do Tratamento , Adulto JovemRESUMO
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.
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Técnicas Cosméticas , Envelhecimento da Pele , Envelhecimento , Estética , Humanos , Ácido Hialurônico , Lactente , Satisfação do Paciente , Estudos Prospectivos , Resultado do TratamentoRESUMO
BACKGROUND: Fibrous septae play a role in contour alterations associated with cellulite. OBJECTIVE: To assess collagenase clostridium histolyticum-aaes (CCH) for the treatment of cellulite. MATERIALS AND METHODS: Two identically designed phase 3, double-blind, randomized studies (RELEASE-1 and RELEASE-2) were conducted. Adult women with moderate/severe cellulite (rating 3-4 on the Patient Reported Photonumeric Cellulite Severity Scale [PR-PCSS] and Clinician Reported PCSS [CR-PCSS]) on the buttocks received up to 3 treatment sessions of subcutaneous CCH 0.84 mg or placebo per treatment area. Composite response (≥2-level or ≥1-level improvement from baseline in both PR-PCSS and CR-PCSS) was determined at Day 71. RESULTS: Eight hundred forty-three women received ≥1 injection (CCH vs placebo: RELEASE-1, n = 210 vs n = 213; RELEASE-2, n = 214 vs n = 206). Greater percentages of CCH-treated women were ≥2-level composite responders versus placebo in RELEASE-1 (7.6% vs 1.9%; p = .006) and RELEASE-2 (5.6% vs 0.5%; p = .002) and ≥1-level composite responders in RELEASE-1 (37.1% vs 17.8%; p < .001) and RELEASE-2 (41.6% vs 11.2%; p < .001). Most adverse events (AEs) in the CCH group were injection site related; few CCH-treated women discontinued because of an AE (≤4.3%). CONCLUSION: Collagenase clostridium histolyticum-aaes significantly improved cellulite appearance and was generally well tolerated.
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Celulite/tratamento farmacológico , Colagenase Microbiana/uso terapêutico , Anticorpos Neutralizantes/sangue , Método Duplo-Cego , Feminino , Humanos , Reação no Local da Injeção/etiologia , Colagenase Microbiana/efeitos adversos , Colagenase Microbiana/imunologia , Pessoa de Meia-Idade , Satisfação do Paciente , Resultado do TratamentoRESUMO
BACKGROUND: HARC is a soft and flexible hyaluronic acid filler containing lidocaine, manufactured using XpresHAn® technology, restoring natural-looking volume and soft contours. OBJECTIVES: To evaluate safety and effectiveness of HARC for cheek augmentation and correction of midface contour deficiencies compared to a control product HAJV (hereafter referred to as Control). Primary objective was to demonstrate non-inferiority of HARC compared to the Control, by blinded evaluation of change from baseline in midface fullness 12 weeks after last injection, using a 4 grade midface volume scale (MMVS). MATERIALS AND METHODS: Subjects over the age of 21 with loss of fullness in the midface area (MMVS score 2, 3, or 4) were randomized 2:1 to treatment with HARC(n=142) or Control (n=68). Optional touch-up was allowed after 4 weeks. Study assessments included MMVS, aesthetic improvement, subject satisfaction, and safety. Subjects were followed for 48 weeks. RESULTS: Overall, most subjects were female (89%) and mean age was 53 years (range 24-80). Total mean volume injected was 4.3 mL for HARC and 4.9 mL for Control. Primary objective was met; mean change from baseline in MMVS score at week 12: -1.4 (HARC), -1.3 (Control), 95% CI: -0.22, 0.06. HARC effectiveness was supported by a high degree of aesthetic improvement and subject satisfaction throughout 48 weeks. Related adverse events were generally mild and transient. CONCLUSIONS: HARC was well tolerated and non-inferior to Control for correction of midface fullness at 12 weeks after last injection. Aesthetic improvement and subject satisfaction were high and lasted through week 48. J Drugs Dermatol. 2021;20(9):949-956. doi:10.36849/JDD.6191.
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Técnicas Cosméticas , Preenchedores Dérmicos , Envelhecimento da Pele , Adulto , Idoso , Idoso de 80 Anos ou mais , Bochecha , Preenchedores Dérmicos/efeitos adversos , Estética , Feminino , Humanos , Ácido Hialurônico/efeitos adversos , Lidocaína , Pessoa de Meia-Idade , Satisfação do Paciente , Resultado do Tratamento , Adulto JovemRESUMO
BACKGROUND AND OBJECTIVES: The ability to provide improved tattoo fading using multiple laser passes in a single office laser tattoo removal session is limited. In part, this is due to the loss of laser effectiveness caused by epidermal and dermal vacuole "whitening" generated during the initial laser pass at the tattoo site. The Rapid Acoustic Pulse (RAP) device generates acoustic shock wave pulses that clear epidermal and dermal vacuoles to enable multiple laser passes in a single office laser tattoo removal session. The objectives of this study were to determine if the RAP device, when used as an accessory to the 1064 nm Nd:YAG Q-switched (QS) laser can enable delivery of multiple laser passes in a single office laser tattoo removal session, and therefore result in increased tattoo fading compared to the clinical standard single-pass QS laser tattoo removal session. STUDY DESIGN/MATERIALS AND METHODS: The RAP device was evaluated in a single-center (SkinCare Physicians), prospective, IRB approved study. A total of 32 black ink tattoos, from 21 participants, were divided into three zones and treated with either multiple QS laser passes, each followed by 1 minute of RAP device application (Laser + RAP) in zone one and single-pass QS laser treatment (Laser-Only) in zone two, separated by an untreated control zone. The treatment sites were assessed for the number of laser passes and adverse events immediately, 6 weeks, and 12 weeks following the treatment session. Photographs of the treatment sites were assessed for percent fading at 12 weeks post-treatment by three blinded reviewers. RESULTS: When the RAP device was applied as an accessory to the QS laser in a multi-pass laser tattoo removal treatment, an average of 4.2 laser passes were delivered in a single session, with no unexpected or serious RAP device-related adverse events. At the 12-week follow-up, tattoos treated with Laser + RAP showed a statistically significant increase in average fading (44.2%) compared with tattoos treated with Laser-Only (24.8%) (P < 0.01). Additionally, a significantly higher overall proportion of tattoos treated with Laser + RAP (37.5%) had a response of >50% fading compared with tattoos treated with QS Laser-Only (9.4%) (P < 0.01) as well as a response of >75% fading from Laser + RAP treatment (21.9%) compared with Laser-Only treatment (3.1%) (P < 0.05). CONCLUSIONS: The RAP device, applied as an accessory to the 1064 nm Nd:YAG QS laser, safely enables multiple QS laser treatments in a single office laser tattoo removal session by clearing the whitening caused by the previous QS laser pass. Enabling multiple QS laser passes results in a statistically significant increase in tattoo fading in a single office laser tattoo removal session compared to the clinical standard single-pass QS laser tattoo removal session. © 2019 The Authors. Lasers in Surgery and Medicine Published by Wiley Periodicals, Inc.
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Lasers de Estado Sólido/uso terapêutico , Terapia com Luz de Baixa Intensidade/instrumentação , Som , Tatuagem , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Adulto JovemRESUMO
BACKGROUND: The etiology of cellulite is unclear. Treatment of cellulite has targeted adipose tissue, dermis, and fibrous septae with varying degrees of success and durability of response. OBJECTIVE: Results from clinical trials that target different anatomical aspects of cellulite can provide insights into the underlying pathophysiology of cellulite. MATERIALS AND METHODS: A search of the PubMed database and ClinicalTrials.gov website was conducted to identify clinical trials that have investigated treatments for cellulite. RESULTS: A lack of trial protocol standardization, objective means for quantification of improvement and reported cellulite severity, and short-term follow-up, as well as variation in assessment methods have made comparisons among efficacy studies challenging. However, the lack of durable efficacy and inconsistency seen in clinical results suggest that dermal or adipose tissue changes are not the primary etiologies of cellulite. Clinical studies targeting the collagen-rich fibrous septae in cellulite dimples through mechanical, surgical, or enzymatic approaches suggest that targeting fibrous septae is the strategy most likely to provide durable improvement of skin topography and the appearance of cellulite. CONCLUSION: The etiology of cellulite has not been completely elucidated. However, there is compelling clinical evidence that fibrous septae play a central role in the pathophysiology of cellulite.
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Aponeurose/fisiopatologia , Celulite/etiologia , Celulite/terapia , Nádegas , Celulite/fisiopatologia , Ensaios Clínicos como Assunto , Tratamento por Ondas de Choque Extracorpóreas , Humanos , Lipectomia , Massagem , Colagenase Microbiana/administração & dosagem , Músculo Esquelético/fisiopatologia , Fototerapia/métodos , Terapia por Radiofrequência , Pele/fisiopatologia , Creme para a Pele/administração & dosagem , Gordura Subcutânea/fisiopatologia , Coxa da Perna , Resultado do TratamentoRESUMO
BACKGROUND: Aesthetic medicine has evolved from targeting individual treatment areas to a global approach of panfacial rejuvenation. HARMONY was the first clinical study to systematically demonstrate positive physical and psychosocial impacts of panfacial treatment. OBJECTIVE: Provide evidence-based guidance on treatment strategies to help maximize outcomes in patients seeking panfacial rejuvenation. MATERIALS AND METHODS: Study sites with the lowest (n = 2) and highest (n = 2) improvements based on FACE-Q Satisfaction with Face Overall scores were analyzed to understand differences in treatment strategy that may contribute to incrementally greater patient satisfaction. RESULTS: The highest scoring sites exhibited greater improvement in all patient-reported outcomes and investigator-assessed measures related to dermal filler treatment compared with the lowest scoring sites. The highest sites favored lateral malar augmentation and used less volume medially versus the lowest sites. In the lower face, the highest sites used greater volumes and more HYC-24L than HYC-24L+. Initial treatment volumes were more conservative at highest than lowest sites; greater volumes were used by highest sites in touch-up treatments. CONCLUSION: Product usage trends common to the highest scoring sites (including injection volume, injection sites, and product selection) may provide guidance on best practices for a panfacial approach to aesthetic treatment to maximize patient satisfaction.
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Bimatoprost/administração & dosagem , Toxinas Botulínicas Tipo A/administração & dosagem , Técnicas Cosméticas/normas , Ácido Hialurônico/análogos & derivados , Rejuvenescimento , Administração Tópica , Adulto , Idoso , Preenchedores Dérmicos/administração & dosagem , Estética , Medicina Baseada em Evidências/métodos , Medicina Baseada em Evidências/normas , Face/fisiologia , Feminino , Humanos , Ácido Hialurônico/administração & dosagem , Injeções Subcutâneas , Masculino , Pessoa de Meia-Idade , Fármacos Neuromusculares/administração & dosagem , Soluções Oftálmicas/administração & dosagem , Medidas de Resultados Relatados pelo Paciente , Satisfação do Paciente , Guias de Prática Clínica como Assunto , Pele/efeitos dos fármacos , Envelhecimento da Pele/efeitos dos fármacos , Envelhecimento da Pele/fisiologia , Resultado do TratamentoRESUMO
Since initial US Food and Drug Administration approval of botulinum toxin type A (BoNT-A) for aesthetic use in 2002, clinical evidence and experience with BoNT-A and understanding of facial anatomy have greatly increased, leading to rapid advances in treatment planning and implementation. BoNT-A use has expanded from the upper face to the midface, lower face, and neck, so that BoNT-A injection is the most common cosmetic procedure worldwide. Trends in facial aesthetics reflect growing patient diversity with respect to age, gender, and ethnicity. In October 2019, a multidisciplinary panel of 6 experts in minimally invasive injectable procedures in the specialties of dermatology and plastic surgery convened at the 2019 American Society for Dermatologic Surgery (ASDS) meeting in Chicago, IL. Their goal was to discuss recent advances in BoNT-A use in facial aesthetics, including implications of the introduction of new agents in light of an evolving patient population. J Drugs Dermatol. 2020;19(4 Suppl 1):s5-15 To receive a CME certificate of participation, you should: â¢Read the entire publication, including the CME information. â¢Register or log in at www.paradigmmc.com/822 to complete and submit the online posttest and evaluation. Following online completion of the posttest and evaluation, a certificate of participation will be available for download/printing immediately.
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Toxinas Botulínicas Tipo A/administração & dosagem , Consenso , Técnicas Cosméticas/normas , Face/anatomia & histologia , Toxinas Botulínicas Tipo A/efeitos adversos , Congressos como Assunto , Técnicas Cosméticas/efeitos adversos , Estética , Músculos Faciais/efeitos dos fármacos , Músculos Faciais/inervação , Feminino , Humanos , Injeções Intramusculares/efeitos adversos , Injeções Intramusculares/métodos , Injeções Intramusculares/normas , Masculino , Planejamento de Assistência ao Paciente/normas , Satisfação do Paciente , Rejuvenescimento , Fatores Sexuais , Envelhecimento da Pele , Sociedades Médicas/normas , Cirurgia Plástica/normas , Resultado do Tratamento , Estados UnidosRESUMO
Correction to the supplement, Re-examining the Optimal Use of Neuromodulators and the Changing Landscape: A Consensus Panel Update (J Drugs Dermatol. 2020; 19:4 Supp 1).
RESUMO
Since initial US Food and Drug Administration approval of botulinum toxin type A (BoNT-A) for aesthetic use in 2002, clinical evidence and experience with BoNT-A and understanding of facial anatomy have greatly increased, leading to rapid advances in treatment planning and implementation. BoNT-A use has expanded from the upper face to the midface, lower face, and neck, so that BoNT-A injection is the most common cosmetic procedure worldwide. Trends in facial aesthetics reflect growing patient diversity with respect to age, gender, and ethnicity. In October 2019, a multidisciplinary panel of 6 experts in minimally invasive injectable procedures in the specialties of dermatology and plastic surgery convened at the 2019 American Society for Dermatologic Surgery (ASDS) meeting in Chicago, IL. Their goal was to discuss recent advances in BoNT-A use in facial aesthetics, including implications of the introduction of new agents in light of an evolving patient population. J Drugs Dermatol. 2020;19(4 Suppl 1):s5-15To receive a CME certificate of participation, you should: •Read the entire publication, including the CME information. •Register or log in at www.paradigmmc.com/822 to complete and submit the online posttest and evaluation. Following online completion of the posttest and evaluation, a certificate of participation will be available for download/printing immediately.Erratum published for this article here.
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BACKGROUND: Robust and long-term data on true incidence of delayed-onset nodules and immune tolerance of hyaluronic acid (HA) fillers are lacking. OBJECTIVE: To characterize the incidence of delayed nodules in Vycross (VYC) HA fillers compared with previously reported FDA and non-FDA data of all HA fillers. METHODS AND MATERIALS: The incidence of delayed nodules in all patients who had received VYC fillers in a 12-month period was assessed through a retrospective chart review. Nodule incidence for currently approved nonanimal-stabilized hyaluronic acid (NASHA) fillers was assessed using the FDA Summary of Safety and Effectiveness Data. RESULTS: Overall, 1,029 patients received 1,250 VYC filler treatments. Five patients developed delayed nodules to VOB, with an incidence of 1.0% per patient and 0.8% per syringe. No nodules were observed in patients who received VLR or VOL. All nodules were treated successfully using a combination of intralesional triamcinolone and hyaluronidase. Compared with other currently approved NASHA fillers, VOB is associated with a higher incidence of nodule formation. CONCLUSION: The introduction of VYC HAs has introduced a new variable that may be changing the immune tolerance of these substances, resulting in a higher incidence of delayed nodules than previously expected.
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Técnicas Cosméticas/efeitos adversos , Preenchedores Dérmicos/efeitos adversos , Toxidermias/etiologia , Dermatoses Faciais/induzido quimicamente , Ácido Hialurônico/efeitos adversos , Preenchedores Dérmicos/química , Toxidermias/imunologia , Dermatoses Faciais/imunologia , Feminino , Humanos , Ácido Hialurônico/química , Ácido Hialurônico/imunologia , Injeções Intradérmicas , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Medição de RiscoRESUMO
BACKGROUND: Cellulite is a common female cosmetic concern for which there are few treatment options with long-term effectiveness data. The aim of this multisite prospective registry study was to collect observational data on the real-life clinical use of a tissue stabilized-guided subcision (TS-GS) system for long-term improvement of cellulite appearance. METHODS: Fifty-three subjects were enrolled and received a single treatment using the TS-GS system. Physicians treated the subjects according to their standard of care. Global Aesthetic Improvement Scale (GAIS) was completed by the patient and clinician assessing overall aesthetic improvement after 180 days. Treatment parameters, pain scores, quality of life data, and expected treatment effects and adverse events were also recorded throughout the study. RESULTS: The patient and physician GAIS scores at Day 180 revealed an overall improvement in 91% and 96% of patients, respectively. Quality of life and self-confidence scores also improved through 180 days. No serious adverse events were reported. Expected treatment effects were similar to those reported in the pivotal trial supporting FDA clearance. CONCLUSION: This study demonstrated significant improvement in the appearance of cellulite after a single treatment session in patients with moderate-to-severe cellulite. These results are consistent with the previously published the pivotal study data.
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Celulite/cirurgia , Procedimentos Cirúrgicos Minimamente Invasivos , Adulto , Nádegas , Técnicas Cosméticas , Estética , Feminino , Humanos , Medição da Dor , Satisfação do Paciente , Estudos Prospectivos , Qualidade de Vida , Coxa da PernaRESUMO
BACKGROUND: New treatment methods for cellulite require globally accepted scales for aesthetic research and patient evaluation. OBJECTIVE: To develop a set of grading scales for objective assessment of cellulite dimples on female buttocks and thighs and assess their reliability and validity. MATERIALS AND METHODS: Two photonumeric grading scales were created and validated for dimples in the buttocks in female patients: Cellulite Dimples-At Rest, and Cellulite Dimples-Dynamic. Sixteen aesthetic experts rated photographs of 50 women in 2 validation sessions. Responses were analyzed to assess inter-rater and intra-rater reliability. RESULTS: Overall inter-rater reliability and intra-rater reliability were both "almost perfect" (≥0.81, intraclass correlation efficient and weighted kappa) for the At Rest scale. For the Dynamic scale, inter-rater reliability and intra-rater reliability were "substantial" (0.61-0.80). There was a high correlation between the cellulite scales and body mass index, age, weight, and skin laxity assessments. CONCLUSION: Consistent outcomes between raters and by individual raters at 2 time points confirm the reliability of the cellulite dimple grading scales for buttocks and thighs in female patients and suggest they will be a valuable tool for use in research and clinical practice.
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Nádegas , Celulite/diagnóstico , Estética , Exame Físico/métodos , Coxa da Perna , Adulto , Fatores Etários , Índice de Massa Corporal , Peso Corporal , Celulite/terapia , Técnicas Cosméticas , Feminino , Humanos , Variações Dependentes do Observador , Fotografação , Reprodutibilidade dos Testes , Fenômenos Fisiológicos da Pele , Adulto JovemRESUMO
BACKGROUND: The demand for noninvasive skin-tightening body procedures is increasing. OBJECTIVE: To develop a set of grading scales for the objective assessment of skin laxity and assess their reliability and validity. MATERIALS AND METHODS: Two photonumeric grading scales were created and validated for skin laxity in female patients: Skin Laxity-Posterior Thighs/Buttocks, and Anterior Thighs/Knees. Fifteen aesthetic experts rated photographs of 50 women in 2 validation sessions. Responses were analyzed to assess inter-rater and intra-rater reliability. RESULTS: Overall inter-rater reliability according to intraclass correlation efficient (ICC) 2.1 and weighted kappa was at least "substantial" for both scales in both sessions, and "almost perfect" (≥0.81) for the Anterior Thighs and Knees scale in session 2. Intra-rater reliability was "almost perfect" for both scales (ICC 2.1) and "substantial" to "almost perfect" by weighted kappa. A correlation between the skin laxity scales and body mass index, age, weight, sun exposure, and cellulite severity was observed. CONCLUSION: The skin laxity photonumeric grading scales are valid and reliable instruments for assessing laxity on the posterior thighs and buttocks, and anterior thighs and knees. The scales will be of value for standardizing clinical evaluations and quantifying outcome measurements in research and clinical practice.
Assuntos
Nádegas , Estética , Joelho , Exame Físico/métodos , Fenômenos Fisiológicos da Pele , Coxa da Perna , Adulto , Técnicas Cosméticas , Feminino , Humanos , Variações Dependentes do Observador , Fotografação , Reprodutibilidade dos TestesRESUMO
BACKGROUND: Cellulite can be significantly improved using vacuum-assisted tissue stabilized-guided subcision (TS-GS). However, the treatment of shallow and linear cellulite has remained problematic. OBJECTIVE: In this retrospective study, we describe a modified technique of vacuum-assisted TS-GS. The aim is to demonstrate that this new limited-release technique is an effective treatment for long ripples and interconnected shallow dimples, which are characteristic of mild-to-moderate cellulite. METHODS: Patients with mild-to-moderate cellulite were treated with limited-release vacuum-assisted TS-GS. All subcisions were performed at the 6-mm depth and a minimum of 3 mm between each dimple. Using a 4-point scale, 2 raters graded cellulite improvement on evaluation of prephotographs and postphotographs. RESULTS: A total of 23 female patients were included in this study. The pre- and post-treatment photographs were correctly identified in 22 of the 23 patients (95.6%). The average cellulite improvement was 2.9 of 4 for the buttocks and 2.8 of 4 for the posterior thighs. Global cellulite improvement was reported at 3.1 of 4. CONCLUSION: The results demonstrate that modified, limited-release, vacuum-assisted TS-GS can be an effective and safe method for the treatment of long ripples and shallow dimples that are characteristics of mild-to-moderate cellulite.