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1.
Artigo em Inglês | MEDLINE | ID: mdl-38946551

RESUMO

Importance: The demand for less invasive nasal procedures has been increasing, highlighting a gap in research on alternatives beyond fillers. This review explores the potential of neuromodulators and energy-based devices for nonsurgical rhinoplasty. Observations: Both botulinum toxin and energy-based devices used independently or alongside fillers have been studied for nasal shape adjustments. Neuromodulator injection of the depressor septi nasi can reduce nasal tip droop, which can reduce the appearance of a plunged nose. Treatment of the dilator naris can minimize alar flaring, giving the appearance of a thinner nasal tip. These methods primarily reported patient-reported outcomes. Energy-based devices have been used to address nasal skin quality and shape contouring, including resurfacing devices for rhinophyma with improvement in both physician and patient-reported outcomes. The 1470 nm laser achieved nasal reshaping after two sessions. Radiofrequency microneedling was notable for volumetric reduction in the nose (excluding nasal tip), confirmed by 3D imaging, lasting about 12 months. Conclusions and Relevance: The use of neuromodulators and energy-based devices may offer promising results for nasal reshaping. However, there is a need for further comparison studies using both objective measures such as 3D photography and physician and patient-reported outcomes, prior to establishing best practices for these techniques.

2.
Aesthet Surg J ; 2024 Jul 05.
Artigo em Inglês | MEDLINE | ID: mdl-38967686

RESUMO

Non-surgical aesthetic procedures have been steadily growing in popularity among patients of all ages and ethnicities. At present, the literature remains devoid of guidelines on optimal practices in the delivery of aesthetic medical care to patients on immunosuppressant medications. The authors of this review seek to determine the physiologic responses of immunocompromised patients, with regards to outcomes and potential complications, following non-surgical aesthetic procedures and to suggest recommendations for optimal management of these patients. A comprehensive systematic review of the literature was performed to identify clinical studies of patients who had undergone non-surgical aesthetic procedures while immunosuppressed. 43 articles reporting on 1690 immunosuppressed patients who underwent filler injection were evaluated, of which the majority (99%; 1682/1690) were HIV patients while the remaining eight were medically immunosuppressed. The complication rate of filler in this population was of 28% (481/1690), with subcutaneous nodules consisting of the most frequently reported adverse event. A detailed synthesis of complications and a review of the inflammatory responses and impact of immunosuppressants and HIV infection on filler complications is presented. The authors concluded that patients on immunomodulatory medications may be at increased risk of filler granuloma relative to the general population, while patients on immunosuppressants may be at increased risk of infectious complications. Rudimentary guideines for optimal pre-proceural patient assessment, aseptic technique, injection technique and finally anti-bacterial and anti-viral prophylaxis are reviewed. Ongoing advancements in our understanding of the mechanisms underlying these inflammatory processes will undoubtedly optimize management in this patient population.

3.
Dermatol Surg ; 2024 Feb 13.
Artigo em Inglês | MEDLINE | ID: mdl-38349851

RESUMO

BACKGROUND: As gender diversity becomes increasingly embraced by society, and despite growing recognition of the unique needs of transgender patients, the literature remains devoid of guidelines for gender affirming facial feminization or masculinization techniques. OBJECTIVE: The authors seek to identify and discuss target feminine and masculine facial features, as well as an armamentarium of surgical and nonsurgical strategies to effectively address and achieve them in the transgender population. METHODS: A search of the National Library of Medicine database (PubMed) was undertaken to identify the existing literature on gender-affirming facial feminization and masculinization techniques. RESULTS: The importance of assessing proportional relationships between the bitemporal, bizygomatic, and bigonial distances is discussed; ideal masculine faces possess a rectangular face shape, with ratios for these 3 areas tending toward 1:1:1. Conversely, the ideal female face is heart shaped with projection at the zygoma and a tapered jawline. Strategic positioning of the cheek apex serves as an anchor in sculpting a distinctly masculine or feminine face. Other considerations include the enhancement of skin quality and implications of hormonal therapy. CONCLUSION: The aesthetic considerations provided in this study can serve as a valuable guidance for aesthetic physicians seeking to deliver optimal care for their transitioning patients.

4.
Dermatol Surg ; 49(4): 383-386, 2023 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-36826346

RESUMO

BACKGROUND: Collagenase clostridium histolyticum-aaes (CCH) is approved for the treatment of moderate-to-severe cellulite. OBJECTIVE: This is a retrospective image review of subjects previously enrolled in Cohort 2 of the EN3835-305 trial to determine the effects of CCH on volumetric changes of cellulite dimples and overall gluteal contouring. METHODS: In this retrospective analysis, photographs from Day 90 and Day 180 were superimposed on baseline images and the volumetric change of each treated cellulite dimple was quantified. Side-by-side photographs of the buttocks were also evaluated for change in gluteal contour using the Physician Global Aesthetic Improvement Scale (PGAIS). RESULTS: Fifty-eight female subjects and 403 cellulite dimples were evaluated. Three-dimensional imaging analysis revealed a significant improvement in total negative dimple volume at both Day 90 and Day 180 of 27% and 26%, respectively ( p < .001 and p = .002, respectively). At Day 90, the overall gluteal contour, as signified by the mean PGAIS among the 3 blinded dermatologists, was rated as +1 (improved) in 27% ( n = 17) of the subjects. At Day 180, the mean PGAIS was +1 (improved) or +2 (very much improved) in 39% ( n = 26) of the subjects. CONCLUSION: CHH is an effective tool for treating cellulite dimples and improving gluteal contour.


Assuntos
Celulite , Técnicas Cosméticas , Feminino , Humanos , Celulite/terapia , Injeções Intralesionais , Colagenase Microbiana , Estudos Retrospectivos , Coxa da Perna , Resultado do Tratamento
5.
Dermatol Surg ; 49(4): 378-382, 2023 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-36826378

RESUMO

BACKGROUND: More than 90% of women report concerns of cellulite on their skin. Poly- l lactic acid (PLLA-SCA) is a biocompatible, semipermanent, synthetic filler that induces neocollagenesis. OBJECTIVE: To investigate the safety and efficacy of PLLA-SCA for the treatment of cellulite of the buttock and thigh regions. METHODS: This was a prospective, single-center, double-blinded, split-body, clinical trial of 20 women with slight to moderate skin laxity of the buttocks and/or thighs contributing to mild-to-moderate cellulite. Each subject's buttocks and thighs were randomized to receive injections with up to 2 vials of PLLA-SCA or the equivalent volume of bacteriostatic water per treatment area. Subjects received at total of 3 treatments 4 weeks apart and were followed for 330 days. RESULTS: Treatment of the buttocks with PLLA-SCA resulted in significant reduction of depression depth, improvement in the morphological appearance of the skin, improvement in the grade of skin laxity, and overall improvement in cellulite appearance. Treated thighs showed reduction in the depth and number of depressions and an improvement in overall cellulite appearance. No significant procedure side effects were found. CONCLUSION: Poly- l lactic acid offers an effective and safe method for treating cellulite of the buttocks and thighs.


Assuntos
Celulite , Técnicas Cosméticas , Humanos , Feminino , Celulite/tratamento farmacológico , Celulite/cirurgia , Coxa da Perna , Nádegas , Estudos Prospectivos , Ácido Láctico/efeitos adversos
6.
Aesthet Surg J ; 43(6): NP438-NP448, 2023 05 15.
Artigo em Inglês | MEDLINE | ID: mdl-36759325

RESUMO

BACKGROUND: The pathogenesis of delayed-onset tissue nodules (DTNs) due to hyaluronic acid (HA) injections is uncertain. OBJECTIVES: To formulate a rational theory for DTN development and their avoidance and treatment. METHODS: A multidisciplinary and multicountry DTN consensus panel was established, with 20 questions posed and consensus sought. Consensus was set at 75% agreement. RESULTS: Consensus was reached in 16 of 20 questions regarding the pathogenesis of DTNs, forming the basis for a classification and treatment guide. CONCLUSIONS: The group believes that filler, pathogens, and inflammation are all involved in DTNs and that DTNs most likely are infection initiated with a variable immune response. Injected filler may incorporate surface bacteria, either a commensal or a true pathogen, if the skin barrier is altered. The initially high molecular weight HA filler is degraded to low molecular weight HA (LMWHA) at the edge of the filler. Commensals positioned within the filler bolus may be well tolerated until the filler is degraded and the commensal becomes visible to the immune system. LMWHA is particularly inflammatory in the presence of any local bacteria. Commensals may still be tolerated unless the immune system is generally heightened by viremia or vaccination. Systemic pathogenic bacteremia may also interact with the filler peripheral LMWHA, activating Toll-like receptors that induce DTN formation. Given this scenario, attention to practitioner and patient hygiene and early systemic infection treatment deserve attention. Classification and treatment systems were devised by considering each of the 3 factors-filler, inflammation, and infection-separately.


Assuntos
Técnicas Cosméticas , Preenchedores Dérmicos , Humanos , Ácido Hialurônico/efeitos adversos , Injeções , Técnicas Cosméticas/efeitos adversos , Inflamação/etiologia , Preenchedores Dérmicos/efeitos adversos
7.
Dermatol Surg ; 49(1): 42-47, 2023 01 01.
Artigo em Inglês | MEDLINE | ID: mdl-36533795

RESUMO

BACKGROUND: The aging process involves laxity, hyperpigmentation, and telangiectasias. It is important to target those elements of aging to be successful at achieving rejuvenation. OBJECTIVE: To determine the efficacy, safety, and patient satisfaction of a combination intense pulsed light (IPL) and 1440-nm diode laser versus either treatment alone. METHODS: Forty subjects were enrolled in this randomized split-face trial: 20 were randomized to Group A (received IPL on one side of the face and IPL followed by the 1440-nm diode laser on the other side) and 20 were randomized to Group B (received 1440-nm diode laser on one side of the face and IPL followed by the 1440-nm diode laser on the other side). RESULTS: Investigators reported a percent improvement of 40% to 50% in all 3 groups at day 120; blinded investigator Global Aesthetic Improvement Scores were better in the combination group-90% compared with 84% and 83% in the IPL and 1440-nm diode laser groups, respectively. Wrinkling scores was significantly improved in the 1440-nm diode and combination groups. Hyperpigmentation and telangiectasias were significantly improved in all 3 groups. Adverse events were self-limited. CONCLUSION: Combination treatment with IPL and 1440-nm diode laser was found to be safe and effective and resulted in higher subject satisfaction.


Assuntos
Hiperpigmentação , Envelhecimento da Pele , Telangiectasia , Humanos , Rejuvenescimento , Lasers Semicondutores/efeitos adversos , Telangiectasia/radioterapia , Telangiectasia/cirurgia , Hiperpigmentação/etiologia , Resultado do Tratamento
8.
Dermatol Surg ; 48(9): 937-942, 2022 09 01.
Artigo em Inglês | MEDLINE | ID: mdl-36054046

RESUMO

BACKGROUND: Radiofrequency microneedling (RFMN) and nonablative fractional 1,550-nm erbium:glass lasers (NAFLs) have been reported to be used with success in neck rejuvenation. There are no head-to-head trials to compare these modalities. OBJECTIVE: The purpose of the study was to compare the efficacy and safety of radiofrequency microneedling and nonablative fractional 1,550-nm erbium:glass lasers for the rejuvenation of the neck. METHODS: This was a single-center, randomized, investigator-blinded clinical trial. A total of 21 subjects were randomized into 2 groups, NAFL and RFMN; subjects received 3 treatments 4 weeks apart and were followed up 12 weeks after last treatment. RESULTS: Subjects in NAFL and RFMN groups showed 42.1% and 8.6% improvement in the Fitzpatrick-Goldman Wrinkling Score, respectively, 41.3% and 16.3% improvement in the elastosis score, respectively. Subjects in the NAFL 1,550-nm erbium:glass group showed significantly better blinded investigator Fitzpatrick-Goldman Wrinkling and Elastosis scores; subjects in the RFMN groups showed a more significant reduction in the Horizontal Neck Wrinkle Severity Score. There was a trend for higher patient satisfaction with the NAFL. CONCLUSION: This study showed that both treatments resulted in significant improvement in wrinkling and elastosis scores; the NAFL treatment was associated with significantly better blinded investigator Fitzpatrick-Goldman Wrinkling and Elastosis scores and better subject satisfaction.


Assuntos
Lasers de Estado Sólido , Envelhecimento da Pele , Érbio , Humanos , Lasers de Estado Sólido/efeitos adversos , Satisfação do Paciente , Rejuvenescimento , Resultado do Tratamento
9.
Dermatol Surg ; 48(9): 978-988, 2022 09 01.
Artigo em Inglês | MEDLINE | ID: mdl-35862680

RESUMO

BACKGROUND: Technology use is at an all-time high and its potential impact on psychological and physiologic health should be explored. OBJECTIVE: The objective of this narrative review was to identify the role of technology use on health and well-being. MATERIALS AND METHODS: Authors performed a review of PubMed and publications of the World Health Organization, Department of Defense, and Centers for Disease Control and Prevention to determine the impact of technology regarding electromagnetic radiation (EM), posture and mobility, sleep disturbance, and psychological stress and well-being. RESULTS: Studies on the impact of EM were conflicting, with about 45% reporting negative consequences and 55% reporting no effect. Radiofrequency EM (RF-EM) may more significantly affect fibroblasts and immature cells. Device use was implicated in worsening cognitive focus, imbalance, and sleep. Social media use affects self-esteem and mental health and is associated with up to 33% presence of addiction. Effects seem to be dose related and more pronounced in younger ages. CONCLUSION: Technology use significantly affects sleep, mental health, and cognitive function. Seeking psychological help, limiting social media use, and reducing use before sleep may partially mitigate these effects. The impact of EM is undetermined, but the WHO lists RF-EM as a potential carcinogen.


Assuntos
Saúde Mental , Estresse Psicológico , Envelhecimento , Humanos , Sono , Tecnologia
10.
Plast Reconstr Surg Glob Open ; 10(5): e4306, 2022 May.
Artigo em Inglês | MEDLINE | ID: mdl-35646496

RESUMO

Background: Collagen-rich fibrous septae and subcutaneous adipose protrusions play a role in cellulite pathophysiology. Collagenase clostridium histolyticum-aaes (CCH-aaes) injection causes enzymatic release of septae to resolve cellulite depressions and create a skin smoothing effect. This analysis pooled data from two identically designed, phase-3, randomized, double-blind, placebo-controlled studies to examine the efficacy and safety of CCH-aaes. Methods: Adult women with moderate/severe cellulite (3-4 on Clinician Reported Photonumeric Cellulite Severity Scale and Patient Reported Photonumeric Cellulite Severity Scale) on the buttocks received up to three treatment sessions (Days 1, 22, and 43) of subcutaneous CCH-aaes 0.84 mg or placebo per treatment area. Composite and individual component response (≥2-level or ≥1-level improvement from baseline in Patient Reported Photonumeric Cellulite Severity Scale and/or Clinician Reported Photonumeric Cellulite Severity Scale) and additional patient-reported outcomes were determined at Day 71. Results: Analysis included 424 CCH-aaes-treated and 419 placebo-treated women. CCH-aaes-treated women were 5.9 times more likely than placebo-treated women to be ≥2-level composite responders at Day 71 (odds ratio [95% confidence interval], 5.9 [2.2-15.4]; P < 0.001). A significantly greater percentage of CCH-aaes-treated women versus placebo-treated women were ≥1-level composite responders at Day 71 (39.4% versus 14.6%; P < 0.001). Subgroup analyses indicated no apparent impact of Fitzpatrick skin type category and baseline cellulite severity (moderate/severe) on CCH-aaes efficacy. An inverse relationship between age and CCH-aaes response was observed in those with a body mass index less than 32 kg per m2. The most common adverse events with CCH-aaes were injection-site bruising and injection-site pain. Conclusion: CCH-aaes treatment significantly improved moderate-to-severe buttock cellulite appearance and was generally well tolerated.

11.
Dermatol Surg ; 48(6): 659-663, 2022 06 01.
Artigo em Inglês | MEDLINE | ID: mdl-35412474

RESUMO

BACKGROUND: Vascular occlusions that threaten skin integrity, although not an emergency like those that threaten a patient's vision, is an urgent situation. Accurately interpreting physical examination findings is paramount. The use of high-dose, pulsed hyaluronidase is the mainstay of therapy; however, adjunctive measures that may optimize clearance of an occlusion and/or skin barrier repair such as the use of image guidance and hyperbaric oxygen should be considered. OBJECTIVE: To provide a review of the literature on the treatment of vascular occlusions threatening skin barrier integrity and develop a step-wise treatment guide. MATERIALS AND METHODS: The authors searched PubMed for peer-reviewed studies, consensus statements, case series, and case reports using a variety of keywords. RESULTS: Twenty-six articles focusing on vascular occlusions threatening the skin barrier were reviewed. The authors collectively agreed on treatments to reverse vascular occlusions and restore the skin barrier. The importance of high-dose, pulsed hyaluronidase was clear. Therapies that lacked evidence such as sodium thiosulfate were also revealed. CONCLUSION: A vascular occlusion that threatens skin integrity is an urgent matter which requires accurate interpretation of physical examination findings that will help guide intervention. High-dose, pulsed hyaluronidase along with adjunctive measures performed in a step-wise manner is key to an optimal outcome.


Assuntos
Preenchedores Dérmicos , Doenças Vasculares , Preenchedores Dérmicos/uso terapêutico , Humanos , Ácido Hialurônico , Hialuronoglucosaminidase/uso terapêutico , Pele/irrigação sanguínea
12.
Aesthet Surg J ; 42(8): 937-945, 2022 08 01.
Artigo em Inglês | MEDLINE | ID: mdl-35089992

RESUMO

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 (n = 20) 21 to 55 years old with a BMI ≤ 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 mean ≥1-point reduction in the Cellulite Severity Scale at 180 days. RESULTS: Most patients (n = 18, 95%) achieved the primary endpoint. All patients (n = 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.


Assuntos
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 Jovem
13.
Dermatol Surg ; 48(1): 101-108, 2022 01 01.
Artigo em Inglês | MEDLINE | ID: mdl-34904577

RESUMO

BACKGROUND: Regenerative aesthetics is an emerging branch of regenerative medicine with therapies aimed at recapturing youthful structure and function using the body's own systems. OBJECTIVE: To introduce the field of regenerative aesthetics, and to explore themes and evidence surrounding current and emerging therapies in the field. MATERIALS AND METHODS: A review of the literature was performed for each of the 3 pillars of regeneration; namely, stem cells, biochemical cues, and scaffolds. RESULTS: Herein, we provide an overview of the field of regenerative aesthetics, a discussion surrounding the 3 pillars of regeneration, and an overview of the evidence supporting current and emerging therapeutic modalities that could play a pivotal role in the future of aesthetic treatments. CONCLUSION: An enhanced understanding of this field can serve to further enhance our awareness about the regenerative effects of therapies we already offer, in addition to providing inspiration for future innovation.


Assuntos
Estética , Medicina Regenerativa/métodos , Rejuvenescimento , Humanos , Medicina Regenerativa/tendências
15.
Dermatol Surg ; 47(6): 768-774, 2021 06 01.
Artigo em Inglês | MEDLINE | ID: mdl-33867470

RESUMO

BACKGROUND: A significant population of aesthetic patients are postpartum women motivated to achieve a more youthful abdomen. Although traditionally, abdominoplasty was the treatment of choice, minimally invasive procedures have grown in popularity because of minimal downtime and the favorable side effect profile. so many women share concerns regarding their postpartum abdominal appearance, a limited number of studies focus specifically on postpartum abdominal rejuvenation. OBJECTIVE: To review pertinent aspects of abdominal anatomy, associated changes with pregnancy, available nonsurgical cosmetic procedures, and to provide our experience to help guide treatment combinations which comprehensively address the concerns of the postpartum patient. MATERIALS AND METHODS: A review of the literature surrounding nonsurgical treatment options for postpartum abdominal lipohypertrophy, muscle changes, tissue laxity, and striae gravidarum, along with the authors' experience in this area are provided. CONCLUSION: This review summarizes available nonsurgical modalities to address postpartum abdominal defects, including procedures that tone muscles, reduce fat, tighten skin, and improve the appearance of striae. Both the published literature and the authors' experience favor a combination of treatments to address the various lamellae affected by pregnancy. Further clinical trials focusing on the postpartum patient would further help create a standardized approach for postpartum abdominal rejuvenation.


Assuntos
Técnicas Cosméticas , Rejuvenescimento , Estrias de Distensão/terapia , Músculos Abdominais/fisiopatologia , Parede Abdominal/fisiopatologia , Terapia Combinada/métodos , Estética , Feminino , Ganho de Peso na Gestação/fisiologia , Humanos , Período Pós-Parto/fisiologia , Pele/fisiopatologia , Envelhecimento da Pele/fisiologia , Estrias de Distensão/fisiopatologia , Resultado do Tratamento
16.
Dermatol Surg ; 47(5): 649-656, 2021 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-33840781

RESUMO

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.


Assuntos
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 Tratamento
17.
Dermatol Surg ; 47(1): 48-54, 2021 01 01.
Artigo em Inglês | MEDLINE | ID: mdl-32773446

RESUMO

BACKGROUND: DaxibotulinumtoxinA for Injection (DAXI) is botulinum toxin Type A formulated with a novel peptide excipient. Two pivotal, single-treatment, placebo-controlled trials demonstrated efficacy and safety for moderate or severe glabellar lines. OBJECTIVE: To further evaluate DAXI in a large, open-label, repeat-treatment study. METHODS: Subjects (n = 2,691) were enrolled from the preceding pivotal trials or de novo and received 40U DAXI. Those who received repeat treatments could be retreated when they returned to baseline on the Investigator Global Assessment-Frown Wrinkle Severity (IGA-FWS) and Patient FWS (PFWS) scales at/after 12 weeks and up to 36 weeks after treatment. RESULTS: High (>96%) response rates (none or mild severity) on the IGA-FWS scale were seen after each of the 3 treatments, with peak response between Weeks 2 to 4. At Week 24, ≥32% had a response of none or mild severity. Peak response rates of ≥92% were observed at Weeks 2 to 4 on the PFWS scale. The median duration for return to moderate or severe severity was 24 weeks. The safety profile was favorable and consistent with previous trials. CONCLUSION: DaxibotulinumtoxinA for Injection efficacy was highly consistent across treatment cycles. These results confirm the previously observed efficacy rates and duration of response.


Assuntos
Toxinas Botulínicas Tipo A/uso terapêutico , Testa , Fármacos Neuromusculares/uso terapêutico , Envelhecimento da Pele/efeitos dos fármacos , Adulto , Idoso , Idoso de 80 Anos ou mais , Toxinas Botulínicas Tipo A/efeitos adversos , Feminino , Humanos , Injeções , Masculino , Pessoa de Meia-Idade , Fármacos Neuromusculares/efeitos adversos
20.
Dermatol Surg ; 46(12): 1623-1627, 2020 12.
Artigo em Inglês | MEDLINE | ID: mdl-32852426

RESUMO

BACKGROUND: Skin laxity of the upper knee and lower thigh is a common complaint among patients. OBJECTIVE: This is a randomized, double-blinded, split-body, placebo-controlled study to evaluate the safety and efficacy of poly-L-lactic acid (PLLA) for treatment of upper knee skin laxity. MATERIALS AND METHODS: Twenty female subjects between the ages of 30 and 65 years with upper knee laxity were enrolled. The patients were randomized to receive 3 treatments of PLLA in 1 knee, whereas the other knee received 3 treatments of bacteriostatic water. RESULTS: Statistically significant improvement as rated on the physician global aesthetic improvement scale was seen at Day 56 after final treatment in the active knee when compared with the placebo knee. This improvement was sustained at Day 84 and Day 168 after final treatment visits. No statistically significant difference was seen between the active and placebo knees on the subject global aesthetic score or the subject satisfaction scale. CONCLUSION: Based on our study, PLLA may be a safe and effective modality in addressing upper knee skin laxity. Larger studies with longer follow-up times and a validated knee laxity scale are needed to further determine if and how much improvement can be achieved.


Assuntos
Técnicas Cosméticas/efeitos adversos , Poliésteres/administração & dosagem , Envelhecimento da Pele/efeitos dos fármacos , Idoso , Método Duplo-Cego , Estética , Feminino , Seguimentos , Humanos , Joelho , Pessoa de Meia-Idade , Satisfação do Paciente , Fotografação , Placebos/administração & dosagem , Placebos/efeitos adversos , Poliésteres/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto , Pele/diagnóstico por imagem , Pele/efeitos dos fármacos , Resultado do Tratamento
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