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1.
Aesthet Surg J ; 2024 Apr 18.
Artigo em Inglês | MEDLINE | ID: mdl-38636497

RESUMO

BACKGROUND: In 2022, the US experienced a significant increase in demand for minimally invasive aesthetic procedures, underscoring its rising acceptance amidst an unregulated educational environment for practitioners. The absence of standardized educational pathways and quality control in aesthetic medicine, primarily provided by non-academic institutions, highlights a critical need for establishing educational standards to ensure practitioner competence and patient safety. OBJECTIVES: To identify levels of competency for the aesthetic practitioner and for necessary achievement milestones during the educational path from novice to expert injector. METHODS: A total of n = 386 international study participants responded to an online questionnaire regarding their experience in aesthetic medicine practice. The questionnaire comprised 58 questions focusing on professional data, the perceived difficulty of injection and risk for the occurrence of adverse events for specific facial regions in soft tissue filler and toxin injections. RESULTS: Regardless of medical specialty and experience level, an average of 3.85 (1.8) years, 786.4 (2,628) filler injections, and 549.9 (1,543) toxin injections was estimated to progress from novice to advanced injector, while an average of 6.10 (3.7) years, 1,842.2 (4,793) filler injections, and 1,308.5 (3,363) injections was estimated to advance from advanced to expert injector. The nose and the perioral region have been ranked as the facial regions most difficult to achieve a perfect aesthetic outcome and with the greatest risk for the occurrence of adverse events for filler and toxin injections, respectively. CONCLUSIONS: This study establishes an educational framework in aesthetic medicine by defining the progression from novice to competent and expert injector levels, suggesting 4 years of practice and over 790 filler and 550 neuromodulator injections for competence, and at least 6 years with 1,840 filler and 1,310 neuromodulator injections for expertise. It also identifies critical facial regions for targeted treatments by different expertise levels.

2.
J Am Acad Dermatol ; 88(1): 79-85, 2023 01.
Artigo em Inglês | MEDLINE | ID: mdl-31325548

RESUMO

BACKGROUND: Hyaluronic acid fillers are known for a reliable safety profile, but complications do occur, even serious vascular adverse events. OBJECTIVE: To improve the treatment outcome after a vascular adverse event with use of hyaluronic acid filler treatments. METHODS: Duplex ultrasonography is used to detect the hyaluronic acid filler causing the intra-arterial obstruction. RESULTS: If treated in time, 1 single treatment of ultrasonographically guided injections of hyaluronidase into the filler deposit will prevent skin necrosis. CONCLUSION: Because the use of duplex ultrasonography adds extra essential information, its use may become an integral part of the prevention and treatment of injection adverse events.


Assuntos
Técnicas Cosméticas , Preenchedores Dérmicos , Humanos , Técnicas Cosméticas/efeitos adversos , Preenchedores Dérmicos/efeitos adversos , Ácido Hialurônico/efeitos adversos , Hialuronoglucosaminidase/uso terapêutico , Injeções , Ultrassonografia
3.
Artigo em Inglês | MEDLINE | ID: mdl-38084783

RESUMO

BACKGROUND: Minimally invasive lip volumizing and contouring soft tissue filler procedures are frequently requested by both female and male aesthetic patients. Guidance on how to achieve the most beautiful outcome is inconsistent. OBJECTIVE: To investigate what the most beautiful proportions are in relation to vermillion thickness, the distance of the upper and lower lip in relation to nose and chin, and relation to the bigonial distance. METHODS: This study included a total of n = 101 volunteers (52 females, 49 males, 100% Caucasian) who inspected frontal images of modified facial proportions and answered a related questionnaire showcasing the same images. Image presentation followed a randomized sequence both for the eye tracking and for the survey component of this study but was equal for all observers. RESULTS: The most attractive vertical position of lips was the 1:2 ratio in which the distance between lips and chin is double the length as the distance between lips and nose. For the ratio between the width of the lips and the bigonial distance, it was the 1:2.5 ratio, whereas for the thickness of the upper lip vermilion in relation to the upper lip ergotrid it was the 1:3/1:2 (male/female) ratio and for the lower lip vermilion and lower lip ergotrid it was the 1:4 ratio for both genders. CONCLUSION: The results of this eye tracking and survey-based investigation revealed that instead of one single universal ratio, multiple facial proportions exist that are perceived as most attractive/masculine/feminine. Regarding the perception of facial aesthetics, it appears there is a distinction between attractiveness and masculinity/femininity: the most attractive male/female face is not necessarily the most masculine or feminine.

4.
Aesthet Surg J ; 42(4): 349-357, 2022 03 15.
Artigo em Inglês | MEDLINE | ID: mdl-34363459

RESUMO

BACKGROUND: An increasing number of soft tissue filler procedures in the nasal region has been reported. Concomitant with demand, the number of complications has risen due to the difficulty in administering filler in a region where soft tissue layering is complex. OBJECTIVES: The authors sought to describe the layered soft tissue arrangement of the nose as it relates to the underlying arterial vasculature and to define safer zones for nasal filler enhancement. METHODS: A total of 60 (28 males and 32 females) study participants were investigated with respect to their layered anatomy in the midline of the nose utilizing ultrasound imaging. The presence and extent of the layered arrangement was examined as well as the depth of the arterial vasculature. RESULTS: In the mid-nasal dorsum, a 5-layer arrangement was observed in 100% (n = 60) of all investigated cases, whereas it was found to be absent in the nasal radix and tip. The 5-layer arrangement showed an average extent of 26.7% to 67.5% in relation to nasal length. The nasal arteries coursed superficially in 91.7% of all cases in the nasal radix, in 80% in the mid-nasal dorsum, and in 98.3% in the nasal tip. CONCLUSIONS: Soft tissue filler administration in the nose carries the highest risk for irreversible vision loss compared with any other facial region. The safety of soft tissue filler rhinoplasty procedures is enhanced by knowledge of the layered anatomy of the nose, the location and depth of the major nasal vasculature, and employment of maneuvers to decrease the risk of blindness.


Assuntos
Nariz , Rinoplastia , Artérias/anatomia & histologia , Cegueira , Face/diagnóstico por imagem , Face/cirurgia , Feminino , Humanos , Masculino , Nariz/cirurgia , Rinoplastia/efeitos adversos , Rinoplastia/métodos , Ultrassonografia
5.
Aesthet Surg J ; 42(1): 1-9, 2022 01 01.
Artigo em Inglês | MEDLINE | ID: mdl-33784397

RESUMO

BACKGROUND: Our understanding of the functional anatomy of the face is constantly improving. To date, it is unclear whether the anatomic location of the line of ligaments has any functional importance during normal facial movements such as smiling. OBJECTIVES: The authors sought to identify differences in facial movements between the medial and lateral midface by means of skin vector displacement analyses derived from 3-dimensional (3D) imaging and to further ascertain whether the line of ligaments has both a structural and functional significance in these movements. METHODS: The study sample consisted of 21 healthy volunteers (9 females and 12 males) of Caucasian ethnic background with a mean age of 30.6 (8.3) years and mean BMI of 22.57 (2.5) kg/m2. 3D images of the volunteers' faces in repose and during smiling (Duchenne type) were taken. 3D imaging-based skin vector displacement analyses were conducted. RESULTS: The mean horizontal skin displacement was 0.08 (2.0) mm in the medial midface (lateral movement) and was -0.08 (1.96) mm in the lateral midface (medial movement) (P = 0.711). The mean vertical skin displacement (cranial movement of skin toward the forehead/temple) was 6.68 (2.4) mm in the medial midface, whereas it was 5.20 (2.07) mm in the lateral midface (P = 0.003). CONCLUSIONS: The results of this study provide objective evidence for an antagonistic skin movement between the medial and lateral midface. The functional boundary identified by 3D imaging corresponds to the anatomic location of the line of ligaments.


Assuntos
Face , Sorriso , Adulto , Face/diagnóstico por imagem , Feminino , Testa , Humanos , Imageamento Tridimensional , Masculino
6.
Aesthet Surg J ; 42(4): NP218-NP229, 2022 03 15.
Artigo em Inglês | MEDLINE | ID: mdl-34626170

RESUMO

BACKGROUND: Minimally invasive and noninvasive facial aesthetic treatments are increasingly popular, and a greater understanding of patient perspectives on facial aesthetic priorities is needed. OBJECTIVES: The authors surveyed facial aesthetic concerns, desires, and treatment goals of aesthetically conscious men and women, and physicians, in 18 countries. METHODS: This was a global, internet-based survey on desired appearance and experiences with, or interest in, facial aesthetic treatments. Eligible respondents were aesthetically conscious adults (21-75 years). Eligible aesthetic physicians were required to see ≥30 patients per month for aesthetic reasons, have 2 to 30 years of experience in clinical practice, and spend ≥70% of their time in direct patient care. RESULTS: A total of 14,584 aesthetically conscious adults (mean age, 41 years; 70% women) and 1315 aesthetic physicians (mean age, 45 years; 68% men) completed the survey. Most respondents (68%) reported that aesthetic procedures should be sought in their 30s to 40s; physicians recommended patients seek treatment earlier. Respondents expressed greatest concern over crow's feet lines, forehead lines, facial skin issues, hair-related concerns, and under-eye bags or dark circles; in contrast, physicians tended to underestimate concerns about under-eye bags or dark circles, mid-face volume deficits, and skin quality. Although both physicians and respondents cited cost as a major barrier to seeking aesthetic treatments, respondents also emphasized safety, fear of injections or procedure-related pain, and concern about unnatural-looking outcomes. CONCLUSIONS: This global survey provides valuable insight into facial aesthetic concerns and perspectives that may be implemented in patient education and consultations to improve patient satisfaction following aesthetic treatments.


Assuntos
Técnicas Cosméticas , Médicos , Envelhecimento da Pele , Adulto , Técnicas Cosméticas/efeitos adversos , Estética , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Percepção , Transtornos Fóbicos , Inquéritos e Questionários
7.
Aesthet Surg J ; 42(12): 1460-1469, 2022 12 14.
Artigo em Inglês | MEDLINE | ID: mdl-35922149

RESUMO

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.


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 Tratamento
8.
J Drugs Dermatol ; 20(5): 498-502, 2021 May 01.
Artigo em Inglês | MEDLINE | ID: mdl-33938685

RESUMO

BACKGROUND: To date no precise data are available for extrusion forces related to the G-prime and G-double-prime of fillers in combination with different 27G and 30G needles. Therefore, the objective of this study was to analyze extrusion forces of various product-needle-combinations containing two different 27G and two different 30G needles in combination with fillers of a wide range of elastic moduli starting from 2.0 – 166.0 Pa. MATERIAL AND METHODS: Four different fillers with the following elastic moduli 1.87, 11.65, 61.80, 165.50 Pa were combined with four different needles: 27G ½”, internal diameter: 0.300 μm; 27G ½”, internal diameter: 0.241 μm; 30G ½”, internal diameter: 0.241 μm and 30G ½“, internal diameter: 0.240 μm. Product-needle-combination were subjected to uni-axial mechanical testing and the respective extrusion force was measured. RESULTS: The results of this study revealed that the G-prime and the G-double-prime of a product are statistically significantly related to their extrusion force, with higher G-prime/G-double-prime products requiring higher extrusion forces. The results additionally revealed that whether the size of the needle was described as 27G or 30G by the respective manufacturer statistically significant differences between the measured extrusion forces were detected. CONCLUSION: Injectors need to be aware that not every 27G/30G needle has the same extrusion force even though the external diameter is similar (27G or 30G); this might additionally influence the ability to withdraw blood during a pre-injection aspiration manoeuvre. J Drugs Dermatol. 20(5): doi:10.36849/JDD.5237.


Assuntos
Técnicas Cosméticas , Preenchedores Dérmicos/administração & dosagem , Ácido Hialurônico/administração & dosagem , Injeções Subcutâneas/instrumentação , Agulhas , Preenchedores Dérmicos/química , Módulo de Elasticidade , Ácido Hialurônico/química , Injeções Subcutâneas/métodos , Reologia
9.
Aesthet Surg J ; 41(5): 603-612, 2021 04 12.
Artigo em Inglês | MEDLINE | ID: mdl-32162653

RESUMO

BACKGROUND: Autologous fat is known for a reliable and natural safety profile, but complications do occur-even serious vascular adverse events. OBJECTIVES: The authors sought to examine doppler-ultrasound (DUS) imaging for the harvesting and subsequent facial implantation of autologous fat tissue. METHODS: All patients underwent lipofilling treatment of the temporal fosse of the face. DUS examination was performed for preprocedural vascular mapping and imaging of previously injected (permanent) fillers. In addition, the injection of autologous fat was performed DUS-guided. RESULTS: Twenty patients (all female; mean age, 57.9 years; range, 35-64 years). DUS examination showed that 16 of the 20 patients (80%) had been injected with resorbable or nonresorbable fillers elsewhere in the past. The temporal artery could be visualized and avoided in all cases. An average of 1.1 cc of autologous fat was injected in the temporal fossa per side. One case of edema and nodules was described, but no other adverse events were reported. CONCLUSIONS: The utilization of DUS can add valuable information to a lipofilling procedure and should be considered an integral part of a safe lipofilling treatment.


Assuntos
Tecido Adiposo , Face , Tecido Adiposo/transplante , Face/diagnóstico por imagem , Face/cirurgia , Feminino , Humanos , Injeções , Pessoa de Meia-Idade , Pele , Ultrassonografia
10.
Aesthet Surg J ; 41(10): 1107-1119, 2021 09 14.
Artigo em Inglês | MEDLINE | ID: mdl-33325497

RESUMO

The normal course of aging alters the harmonious, symmetrical, and balanced facial features found in youth, not only impacting physical attractiveness but also influencing self-esteem and causing miscommunication of affect based on facial miscues. With this evidence-based paper, the authors aim to provide a comprehensive overview of the latest research on the etiology and progression of facial aging by explaining the aging process from the "inside out," that is, from the bony platform to the skin envelope. A general overview of the changes occurring within each of the main layers of the facial anatomy is presented, including facial skeleton remodeling, fat pad atrophy or repositioning, changes in muscle tone and thickness, and weakening and thinning of the skin. This is followed by an in-depth analysis of specific aging regions by facial thirds (upper, middle, and lower thirds). This review may help aesthetic physicians in the interpretation of the aging process and in prioritizing and rationalizing treatment decisions to establish harmonious facial balance in younger patients or to restore balance lost with age in older patients.


Assuntos
Face , Envelhecimento da Pele , Tecido Adiposo , Adolescente , Idoso , Envelhecimento , Estética , Humanos
11.
Aesthet Surg J ; 41(11): NP1589-NP1598, 2021 10 15.
Artigo em Inglês | MEDLINE | ID: mdl-33652475

RESUMO

BACKGROUND: Injecting soft tissue fillers into the deep plane of the forehead carries the risk of injection-related visual compromise due to the specific course of the arterial vasculature. OBJECTIVES: The aim of this study was to investigate the 2- and 3-dimensional location of the change of plane of the deep branch of the supratrochlear and supraorbital artery, respectively. METHODS: A total of 50 patients (11 males and 39 females; mean age, 49.76 [13.8] years, mean body mass index, 22.53 [2.6] kg/m2) were investigated with ultrasound imaging. The total thickness and the distance of the arteries from the skin and bone surface were measured with an 18-MHz broadband compact linear array transducer. RESULTS: The deep branch of the supraorbital artery changed plane from deep to superficial to the frontalis muscle at a mean distance of 13 mm (range, 7.0-19.0 mm) in males and at 14 mm (range, 4.0-24.0 mm) in females and for the deep branch of the supratrochlear artery at a mean distance of 14 mm in males and females (range, 10.0-19.0 in males, 4.0-27.0 in females) when measured from the superior orbital rim. CONCLUSIONS: Based on the ultrasound findings in this study, it seems that the supraperiosteal plane of the upper and lower forehead could be targeted during soft tissue filler injections because the deep branches of both the supraorbital and supratrochlear arteries do not travel within this plane. The superficial plane of the lower forehead, however, should be avoided due to the unpredictability and inconsistent presence of the central and paracentral arteries.


Assuntos
Testa , Artéria Oftálmica , Cadáver , Feminino , Testa/diagnóstico por imagem , Humanos , Injeções , Masculino , Pessoa de Meia-Idade , Artéria Oftálmica/diagnóstico por imagem , Ultrassonografia
12.
Aesthet Surg J ; 41(5): 616-624, 2021 04 12.
Artigo em Inglês | MEDLINE | ID: mdl-32504468

RESUMO

BACKGROUND: Pre-injection aspiration procedures could increase safety during soft tissue filler injections. However, various influencing factors have been detected in vitro that could result in false negative aspiration results. OBJECTIVE: A case series was retrospectively investigated to identify factors contributing to positive blood aspiration procedures in vivo. METHODS: This study evaluated 213 clinical cases positive for blood aspiration documented in an Asian population: 208 females (43.8 ±â€…7.2 years old) and 5 males (46.8 ±â€…7.8 years old) during soft tissue filler injections. Injection location, layer (depth) of injection, product injected, size of utilized needle (gauge), length of needle (inch), priming of needle (yes/no), injection angle (degree), and time until blood was visible in the needle hub (seconds) were evaluated. RESULTS: The most frequent location where a positive aspiration was observed was the pyriform fossa (n = 56; 26.3%), the most frequent plane was the supra-periosteal plane (n = 195; 91.5%), and the most frequent needle utilized was a 27G needle (n = 125; 58.7%). Statistically significantly more positive cases were identified when the needle was primed compared with an unprimed needle (P < 0.001, which was independent of the product). The estimated incidence rate was 0.04% to 0.9% for having positive aspiration procedures per total performed injection procedures. CONCLUSIONS: Pre-injection aspiration could be a valuable tool to prevent accidental intravascular injection of soft tissue filler. The results of the present investigation show that aspiration can be performed with an acceptable aspiration time, that is, less than 2 seconds, if a suitable product/needle combination is chosen.


Assuntos
Face , Agulhas , Adulto , Feminino , Humanos , Incidência , Injeções , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos
13.
Aesthet Surg J ; 40(12): 1341-1348, 2020 11 19.
Artigo em Inglês | MEDLINE | ID: mdl-32469392

RESUMO

BACKGROUND: Glabellar soft tissue filler injections have been shown to be associated with a high risk of causing injection-related visual compromise. OBJECTIVES: The aim of this study was to identify the course of the superficial branch of the supratrochlear and of the deep branch of the supraorbital artery in relation to the ipsilateral vertical glabellar line and to test whether an artery is located deep to this line. METHODS: Forty-one healthy volunteers with a mean age of 26.17 [9.6] years and a mean BMI of 23.09 [2.3] kg/m2 were analyzed. Ultrasound imaging was applied to measure the diameters, distance from skin surface, distance between the midline, distance between vertical glabella lines, and the cutaneous projection of the supratrochlear/supraorbital arteries at rest and upon frowning. RESULTS: The mean distance between the superficial branch of the supratrochlear artery and the ipsilateral vertical glabellar line was 10.59 [4.0] mm in males and 8.21 [4.0] mm in females, whereas it was 22.38 [5.5] mm for the supraorbital artery in males and 20.73 [5.6] mm in females. Upon frowning, a medial shift in supratrochlear arterial position of 1.63 mm in males and 1.84 mm in females and of 3.9 mm in supraorbital arterial position for both genders was observed. The mean depth of the supratrochlear artery was 3.34 [0.6] mm at rest, whereas the depth of the supraorbital artery was 3.54 [0.8] mm. CONCLUSIONS: The hypothesis that injecting soft tissue fillers next to the vertical glabellar line is safe because the supratrochlear artery courses deep to the crease should be rejected. Additionally, the glabella and the supraorbital region should be considered as an area of mobile, rather than static, soft tissues.


Assuntos
Testa , Artéria Oftálmica , Cadáver , Criança , Feminino , Testa/diagnóstico por imagem , Voluntários Saudáveis , Humanos , Injeções , Masculino , Ultrassonografia
14.
Aesthet Surg J ; 40(12): 1327-1335, 2020 11 19.
Artigo em Inglês | MEDLINE | ID: mdl-32469050

RESUMO

BACKGROUND: Lips are considered a key element of facial attractiveness due to their central position in the face and their elemental role in verbal and nonverbal communication. OBJECTIVES: The authors sought to provide clinically relevant information on the 3-dimensional pathway of the superior and inferior labial arteries within the lips to increase safety during labial soft tissue filler injections. METHODS: The study enrolled 41 healthy volunteers with a mean age of 26.17 ±â€…9.6 years and a mean body mass index of 23.09 ±â€…2.3 kg/m2. Ultrasound imaging was performed at 6 different locations. The position of the labial arteries within the lips, depth of the arteries, cranio-caudal location of each artery in relation to the vermilion border, and diameter of the superior/inferior labial arteries were recorded. RESULTS: The most frequent location of both the superior and inferior labial arteries was the submucosal plane (58.5%) followed by intramuscular (36.2%) and subcutaneous (5.3%) planes. The depth of the superior labial artery in the upper lip was 5.6 ±â€…0.13 mm, whereas the depth of the inferior labial artery in the lower lip was 5.2 ±â€…0.14 mm. Both arteries were more frequently located within the red lip: upper lip (83% vs 18.7%) and lower lip (86.2% vs 13.8%). In the midline, the artery coursed within the red lip in all investigated volunteers. CONCLUSIONS: Clinically, results of this study favor a superficial injection plane for lip volumization procedures. A perpendicular approach to the lip (coming from the cutaneous lip) might increase safety because the artery is located most frequently within the red lip.


Assuntos
Artérias , Lábio , Adolescente , Adulto , Artérias/diagnóstico por imagem , Face/diagnóstico por imagem , Humanos , Injeções , Lábio/diagnóstico por imagem , Ultrassonografia , Adulto Jovem
15.
Aesthet Surg J ; 40(4): 413-429, 2020 03 23.
Artigo em Inglês | MEDLINE | ID: mdl-30951166

RESUMO

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 Tratamento
16.
Aesthet Surg J ; 39(2): 187-200, 2019 01 17.
Artigo em Inglês | MEDLINE | ID: mdl-29762642

RESUMO

Background: OnabotulinumtoxinA and hyaluronic acid are effective in improving moderate to severe facial wrinkles and folds, with treatment selection traditionally based upon facial area. Objectives: This prospective, multicenter, open-label, crossover study evaluated physician-rated efficacy and patient-rated outcomes following moderate to severe facial wrinkles and folds treatment with onabotulinumtoxinA and hyaluronic acid. Methods: 152 subjects (25-65 years) were randomized (1:1) to a treatment-sequence of onabotulinumtoxinA/hyaluronic acid or hyaluronic acid/onabotulinumtoxinA, with initial treatment administered on day 1 and 6 additional visits: week 2 (touch-up); week 4 (crossover); week 6 (touch-up); and weeks 8, 12, and 24 (follow-up). Results: Between 92% and 100% of subjects in each treatment-sequence group exhibited at least some improvement from baseline at each study visit in the Physician Aesthetic Improvement Scale and the Objective Observer and Patient Global Assessments of Improvement, with no significant between-sequence differences. Subjects reported looking 3 to 6 years younger at each visit, with significant improvements in glabellar, lateral canthal, and horizontal forehead lines, and nasolabial folds. Treatments were well tolerated. Conclusions: OnabotulinumtoxinA and hyaluronic acid provide clinically meaningful improvements as rated by physicians, objective observers, and subjects, with clinical synergy in aesthetic effects and duration of response regardless of treatment administration order in subjects seeking improvement in moderate to severe facial wrinkles and folds.


Assuntos
Técnicas Cosméticas/efeitos adversos , Preenchedores Dérmicos/administração & dosagem , Fármacos Neuromusculares/administração & dosagem , Satisfação do Paciente , Envelhecimento da Pele/efeitos dos fármacos , Adulto , Toxinas Botulínicas Tipo A/administração & dosagem , Toxinas Botulínicas Tipo A/efeitos adversos , Estudos Cross-Over , Preenchedores Dérmicos/efeitos adversos , Estética , Feminino , Testa , Humanos , Ácido Hialurônico/administração & dosagem , Ácido Hialurônico/efeitos adversos , Masculino , Pessoa de Meia-Idade , Sulco Nasogeniano , Fármacos Neuromusculares/efeitos adversos , Estudos Prospectivos , Resultado do Tratamento
17.
Ophthalmic Plast Reconstr Surg ; 34(5): 491-496, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29952930

RESUMO

PURPOSE: The Golden ratio, or Phi, has been used to explain the substrates of two-dimensional beauty utilizing the faces of models. A "Phi point" has been identified at the apex of the cheek mound that can be targeted in filler injections. The authors report herein how they have applied this algorithm for surgical shaping of the "beautiful" cheek as a routine part of their lower blepharoplasty procedure. The authors present their technique and results with patients undergoing lower blepharoplasty along with the adjunct of liposculpture to areas of volume deficiency in the midface with a particular goal of enhancing the Phi point. METHODS: This study was retrospective, consecutive, nonrandomized, interventional case series. The authors reviewed the medical records of 113 consecutive patients who underwent lower blepharoplasty with autologous fat transfer to the Phi point. The aesthetic outcome, patient satisfaction, and complication/revisions were evaluated. RESULTS: One hundred two out of 113 patients achieved excellent lower lid position and cheek enhancement as assessed by both patient and surgeon. In these 102 patients, there was significant improvement in lower lid appearance, contour, transition to the cheek, and cheek projection as observed by the surgeon. Three patients required revision to achieve sufficient volume. Eight patients were satisfied with the outcome, nevertheless, requested additional filler injection to optimize. CONCLUSIONS: Lower blepharoplasty combined with autologous fat transfer to reshape the Phi point is a safe and reliable technique and another step further in our quest for recreating the beautiful face.


Assuntos
Tecido Adiposo/transplante , Blefaroplastia/métodos , Bochecha/cirurgia , Cirurgia Plástica/métodos , Adulto , Idoso , Idoso de 80 Anos ou mais , Algoritmos , Estética , Pálpebras/cirurgia , Humanos , Pessoa de Meia-Idade , Satisfação do Paciente , Estudos Retrospectivos , Transplante Autólogo
18.
Dermatol Surg ; 43 Suppl 3: S262-S273, 2017 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-33065952

RESUMO

BACKGROUND: Injectable daxibotulinumtoxinA (RT002) is an investigational botulinum toxin Type A. Published Phase 2 data show that, compared with 20U onabotulinumtoxinA, 40U daxibotulinumtoxinA is associated with a significantly greater response rate and significantly longer duration of response (median 24 weeks), and appears generally safe and well tolerated (www.clinicaltrials.gov NCT02303002). OBJECTIVE: To evaluate whether these efficacy and safety findings are influenced by baseline glabellar line severity. MATERIALS AND METHODS: In the Phase 2, randomized, dose-ranging, parallel-group, double-blind, multicenter study, subjects with moderate or severe glabellar lines at maximum frown were randomly assigned to 20U, 40U, or 60U daxibotulinumtoxinA, 20U onabotulinumtoxinA, or placebo. Efficacy was evaluated by investigators for ≥24 weeks. RESULTS: Data from the per protocol population (n = 191) stratified by baseline glabellar line severity (125 moderate, 66 severe) suggest that the clinical advantage of 40U daxibotulinumtoxinA over 20U onabotulinumtoxinA is maintained for a range of efficacy outcomes regardless of whether glabellar lines are moderate or severe at baseline. Statistical evaluations were not completed due to the limited size of each subgroup. CONCLUSION: 40U daxibotulinumtoxinA appears to offer a clinical efficacy advantage over 20U onabotulinumtoxinA in both moderate and severe glabellar lines-with a greater advantage observed in severe glabellar lines.

19.
Dermatol Surg ; 43(11): 1321-1331, 2017 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-28614091

RESUMO

BACKGROUND: Injectable daxibotulinumtoxinA (RT002) is an investigational botulinum toxin Type A in clinical development. It is formulated with a proprietary peptide and offers the potential of a longer acting neurotoxin therapy. OBJECTIVE: To compare the safety, efficacy, and duration of response of daxibotulinumtoxinA with onabotulinumtoxinA and placebo [www.clinicaltrials.gov NCT02303002]. METHODS: In this Phase 2, randomized, dose-ranging, parallel-group, double-blind, multicenter study, subjects with moderate or severe glabellar lines at maximum frown were randomly assigned to 20U, 40U, or 60U daxibotulinumtoxinA, 20U onabotulinumtoxinA, or placebo. Glabellar line severity was evaluated by investigators and subjects at least every 4 weeks, for at least 24 weeks. RESULTS: Overall, 268 subjects enrolled. Statistical and clinical superiority were observed for 40U and 60U daxibotulinumtoxinA over 20U onabotulinumtoxinA for a range of efficacy outcomes despite the study not being powered to detect statistically significant differences between these active treatment groups. CONCLUSION: The 40U dose of daxibotulinumtoxinA was well tolerated (e.g., absence of ptosis) and had the most favorable risk: benefit profile. Compared with 20U onabotulinumtoxinA, it exhibited a significantly greater response rate and a significantly longer duration of response (median of 24 weeks vs 19 weeks; p = .030).


Assuntos
Toxinas Botulínicas Tipo A/uso terapêutico , Fármacos Neuromusculares/uso terapêutico , Envelhecimento da Pele/efeitos dos fármacos , Toxinas Botulínicas Tipo A/administração & dosagem , Relação Dose-Resposta a Droga , Método Duplo-Cego , Feminino , Humanos , Injeções Intramusculares , Masculino , Pessoa de Meia-Idade , Fármacos Neuromusculares/administração & dosagem , Resultado do Tratamento
20.
Dermatol Surg ; 41 Suppl 1: S284-92, 2015 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-26618455

RESUMO

BACKGROUND: Juvéderm Voluma XC (VYC-20L; hyaluronic acid gel) is approved in the United States for correction of age-related midface volume deficit (MVD). OBJECTIVE: Assess safety and effectiveness of VYC-20L after repeat treatment. METHODS: Subjects with MVD underwent optional repeat treatment 12 to 24 months after initial treatment if correction was lost or at 24 months regardless of loss of correction (n = 167). Investigators rated outcomes on the Mid-Face Volume Deficit Scale (MFVDS) and the Global Aesthetic Improvement Scale (GAIS). Subject-rated outcomes were the GAIS, overall satisfaction with facial appearance, achievement of treatment goal, and Self-Perception of Age questionnaire. Subjects recorded treatment-site responses in 30-day diaries. RESULTS: Mean injection volume for repeat treatment (3.13 mL) was approximately half the mean total injection volume for initial/touch-up treatment (6.8 mL). After repeat treatment, effectiveness was demonstrated on all investigator-rated and subject-rated measures, consistent with results observed after initial treatment. The percentage of subjects improving by ≥1 point on the MFVDS was 82.8% and 91.1% at 6 and 12 months after repeat treatment, respectively. The incidence, severity, and duration of common treatment-site responses were lower after repeat versus initial treatment. CONCLUSION: Repeat treatment with VYC-20L was well tolerated and resulted in high levels of effectiveness and subject satisfaction.


Assuntos
Ácido Hialurônico/administração & dosagem , Satisfação do Paciente , Rejuvenescimento , Adulto , Idoso , Face , Feminino , Humanos , Injeções , Masculino , Pessoa de Meia-Idade , Método Simples-Cego , Inquéritos e Questionários , Fatores de Tempo , Viscossuplementos/administração & dosagem
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