Aesthetic Surgery Journal最新文献

{"title":"Efficacy and Safety of CBL-514 Injection in Reducing Abdominal Subcutaneous Fat: A Randomized, Single-Blind, Placebo-Controlled Phase II Study.","authors":"Michael Gold, Joel Schlessinger, Greg J Goodman, Steven Dayan, Janet DuBois, Yu-Fang Ling, An-Yi Sheu, Wilson W S Ho, Yin-Chia Chou","doi":"10.1093/asj/sjaf032","DOIUrl":"https://doi.org/10.1093/asj/sjaf032","url":null,"abstract":"<p><strong>Background: </strong>A small-molecule injectable drug, CBL-514, has shown promising efficacy and safety for subcutaneous fat reduction.</p><p><strong>Objectives: </strong>To further evaluate the efficacy and safety of CBL-514 for abdominal subcutaneous fat reduction.</p><p><strong>Methods: </strong>In this single-blind, randomized, parallel-group, placebo-controlled Phase 2 trial, 76 participants were randomized (2:1) to receive up to four CBL-514 treatments (2mg/cm², maximum 600mg/treatment) or placebo, administered subcutaneously to the abdomen every 4 weeks. Two follow-up visits were conducted at 4 and 8 weeks post-final treatment. Changes in abdominal subcutaneous fat thickness and volume were measured by ultrasound. The primary endpoint was the proportion of participants with subcutaneous fat volume loss of ≥150mL from baseline compared with placebo.</p><p><strong>Results: </strong>In the intention-to-treat (ITT) population, a significantly higher proportion of CBL-514-treated participants achieved ≥150mL subcutaneous fat volume reduction from baseline compared with placebo-treated participants at both follow-up visits. At 8 weeks post-final treatment, 69.6% of CBL-514-treated participants lost ≥150mL subcutaneous fat, compared with none in the placebo group (p<0.001). Moreover, 60.9% of participants in the CBL-514 group further achieved the ≥200 mL subcutaneous fat loss threshold. Of the 28 participants in CBL-514 group (N=50) who lost ≥150mL subcutaneous fat, 42.9% (12/28 participants) achieved this target after a single treatment. The most common treatment-emergent adverse events were injection site reactions and were of mild to moderate severity.</p><p><strong>Conclusions: </strong>CBL-514 treatment significantly reduced abdominal subcutaneous fat volume with a favorable safety profile. As a non-invasive treatment, CBL-514 could be a new, promising alternative therapy for effective targeted subcutaneous fat reduction.</p>","PeriodicalId":7728,"journal":{"name":"Aesthetic Surgery Journal","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143555605","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Randomized, Double-Blind, Placebo-Controlled, Multi-centered study to Evaluate the Efficacy and Safety of MEI005 in Reducing Submental Fat in Chinese Adults.","authors":"Wenyun Ting, Junxian Wen, Zhijin Li, Jiaming Sun, Jiaping Zhang, Maoguo Shu, Hongwei Liu, Li He, Bo Yu, Nan Jiang, Chunyu Xue, Qian Tan, Xuewen Xu, Sufan Wu, Dan Jian, Hongyi Zhao, Lei Wang, Nanze Yu, Xiaojun Wang","doi":"10.1093/asj/sjaf031","DOIUrl":"https://doi.org/10.1093/asj/sjaf031","url":null,"abstract":"<p><strong>Background: </strong>Submental fat (SMF) is a common aesthetic concern traditionally treated with liposuction. Non-surgical alternatives like injectable deoxycholic acid are gaining popularity. However, no related products have been clinically approved in China.</p><p><strong>Objectives: </strong>This study evaluated the efficacy and safety of MEI005, a deoxycholic acid-based injectable formulation, in reducing SMF in Chinese adults.</p><p><strong>Methods: </strong>This multicenter, randomized, double-blind, placebo-controlled phase III trial included 325 Chinese adults with moderate to SMF. Participants received MEI005 or a placebo injections every 28 days for up to six sessions. Primary endpoints were ≥2-grade improvements in Clinician and Patient-Reported Submental Fat Rating Scales (CR-SMFRS; PR-SMFRS). Secondary endpoints included SMF volume reductions measured by MRI; patient-reported outcomes on the Patient-Reported Submental Fat Impact Scale (PR-SMFIS) and Subject Satisfaction Rating Scale (SSRS); SMF thickness reductions measured by caliper. Adverse events, self-reports, clinical examinations, and checks for skin laxity were monitored.</p><p><strong>Results: </strong>At 12 weeks post-treatment, 18.9% of MEI005 recipients demonstrated simultaneously ≥2-grade CR-SMFRS and PR-SMFRS improvement versus 1.8% for placebo (P<0.001). Additionally, 68.9% of MEI005 group participants achieved simultaneously ≥1-grade improvement in CR-SMFRS and PR-SMFRS, compared to 21.6% of placebo (P<0.001). MRI revealed ≥10% SMF volume reduction in 50% of MEI005 subjects versus 15.2% of placebo (P<0.001). Scores on the PR-SMFIS and SSRS scales showed greater psychological improvement and satisfaction among MEI005 recipients. Vernier caliper measurements showed a 21.42% thickness reduction versus 6.32% (P<0.001). Adverse events were mostly mild to moderate.</p><p><strong>Conclusions: </strong>MEI005 effectively reduces SMF, offering a safe, minimally invasive option for Chinese adults.</p>","PeriodicalId":7728,"journal":{"name":"Aesthetic Surgery Journal","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143555601","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Occurrence of Health Symptoms in General Practice Before and After the Explantation of Cosmetic Breast Implants.","authors":"Annemiek S Lieffering, Marc A M Mureau, Juliëtte E Hommes, Lotte Ramerman, Hinne A Rakhorst, R R W J van der Hulst, R A Verheij","doi":"10.1093/asj/sjaf030","DOIUrl":"https://doi.org/10.1093/asj/sjaf030","url":null,"abstract":"<p><strong>Background: </strong>Explantation of breast implants is increasingly performed in response to concerns about Breast Implant Illness (BII), an array of various health symptoms. However, the benefits of explantation remain unclear due to methodological limitations in prior studies.</p><p><strong>Objectives: </strong>To examine the occurrence of health symptoms before and after explantation of cosmetic breast implants.</p><p><strong>Methods: </strong>Retrospective cohort study linking data from the Dutch Breast Implant Registry and Nivel Primary Care Database. The study included 217 cosmetic explantation patients, and control groups of 228 cosmetic replacement patients, and 433 women without breast implants (non-recipients). BII-related health symptoms presented in general practice were compared between groups one year before and after explantation. Outcomes included any symptom, ≥2 symptoms, ≥3 symptoms, ≥3 consultations, and substantial symptoms (≥3 symptoms with ≥2 consultations for two symptoms).</p><p><strong>Results: </strong>The likelihood of ≥3 symptoms, ≥3 consultations, and substantial symptoms reduced significantly after explantation (OR ≥3 symptoms 0.26, 95% CI [0.08-0.85]; OR ≥3 consultations 0.56, 95% CI [0.32-0.96]; OR substantial symptoms 0.36, 95% CI [0.14-0.94]). However, compared to non-recipients, explantation patients still had higher odds of any symptom, ≥2 symptoms and ≥3 consultations after explantation. Replacement patients also had a reduced likelihood of any symptom, ≥2 symptoms, and ≥3 consultations from pre- to post-surgery.</p><p><strong>Conclusions: </strong>Although explantation appears to improve BII-related health symptoms within a year, women still showed an increased likelihood of symptoms compared to non-recipients.</p>","PeriodicalId":7728,"journal":{"name":"Aesthetic Surgery Journal","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143447894","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Arterioembolic Characteristics of Differentially Diluted CaHA-CMC Gels Within an Artificial Macrovascular Perfusion Model.","authors":"Danny J Soares, Julia Fedorova, Yu Zhang, Akash Chandawarkar, Alexis Bowhay, Larry Blevins, Thomas J Kean, David K Funt","doi":"10.1093/asj/sjaf028","DOIUrl":"https://doi.org/10.1093/asj/sjaf028","url":null,"abstract":"<p><strong>Background: </strong>Despite the recently increased incidence and improved awareness of filler-induced ischemic injuries, the arterioembolic behavior of filler products has not been well described.</p><p><strong>Objectives: </strong>To evaluate the embolic behavior of varying dilutions of Calcium Hydroxylapatite-Carboxymethylcellulose (CaHA-CMC) gel mixtures within an artificial macrovascular perfusion model of the proximal facial artery with correlation against published instances of ischemic injuries in the literature.</p><p><strong>Methods: </strong>CaHA-CMC gel mixtures were assessed via the Pulsatile Unit for the Laboratory Simulation of Arterioembolic Restrictions (PULSAR) system at different flow rates. The occlusive behavior, embolic particle size distributions, and morphological attributes were evaluated through direct photo and videographic captures followed by digital image processing. The PubMed database was systematically queried for all published instances of CaHA-CMC-associated ischemic injuries.</p><p><strong>Results: </strong>Undiluted CaHA-CMC demonstrated highly cohesive behavior upon PULSAR inoculation, with a tendency toward proximal occlusion. Gel fragmentation resulted in a polydisperse embolic mixture averaging 0.151 ± 0.61 mm² (Interquartile Range: 0.006-0.022 mm²) in size. Product dilution had a profound effect on embolic behavior, with a significant reduction in average particle size (0.018 ± 0.03 mm²; Interquartile Range: 0.005-0.018 mm²; p < 0.0001) and complete elimination of proximally occlusive capacity for hyperdiluted mixtures compared to undiluted product (p = 0.002). Confirmed hyperdiluted CaHA-CMC-associated ischemic injuries represented only 3% of published reports, with a predominantly self-limited clinical course.</p><p><strong>Conclusions: </strong>Embolized CaHA-CMC gels produce polydisperse particle mixtures with a preponderance of microparticles. Hyperdilution profoundly reduced the proximally occlusive potential of the product.</p>","PeriodicalId":7728,"journal":{"name":"Aesthetic Surgery Journal","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143447890","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Use of 801 Acellular Dermal Matrices (ADMs) in Direct-to-Implant Breast Reconstruction: A Clinical Observation of Complication Profiles Over a 7-Year Period.","authors":"Haim Yoel Kaplan, Roman Rysin","doi":"10.1093/asj/sjae238","DOIUrl":"10.1093/asj/sjae238","url":null,"abstract":"<p><strong>Background: </strong>The emergence of acellular dermal matrices (ADMs) revolutionized prepectoral breast reconstruction, allowing partial or complete implant coverage. ADM had been described to possess several important benefits; nevertheless, the literature described an increased postoperative complication rate.</p><p><strong>Objectives: </strong>The aim of this study was to delineate H.Y.K.'s experience with ADM in direct-to-implant (DTI) breast reconstruction, and to describe complication rate and patient satisfaction.</p><p><strong>Methods: </strong>This was a retrospective patient cohort that underwent primary or revisional breast reconstruction (DTI) utilizing DermaCell, from Jan 2017 to Jan 2024.</p><p><strong>Results: </strong>A total of 230 consecutive patients, 410 breasts, and 801 DermaCell sheets were evaluated. All were DTI breast reconstructions. Complication rate was described per breast. A total of 92 cases of complication occurred (22.4%). Rippling was seen in 18 breasts (4.39%), skin ischemia in 21 breasts (5.12%), hematoma in 5 (1.21%), and seroma in 9 (2.19%). Seventeen breasts experienced capsular contraction. In the nonirradiated group, capsular contracture (CC), Baker grade 3 to 4, was seen in 4 breasts (1.11%), with 9 (18%) in the irradiated group. The postoperative follow-up period was 18 months (range: 6-84 months). BREAST-Q satisfaction with the breast increased by a mean of 10.45. Satisfaction with the implant was 6.61 out of 8.</p><p><strong>Conclusions: </strong>This cohort study represents the most comprehensive and up-to-date experience with DermaCell for DTI breast reconstructive surgery. The favorable complication profile suggests that DermaCell ADM offers a safe and reliable option, making it an important tool in the armamentarium of reconstructive plastic surgeon. DermaCell is an important component in prepectoral breast reconstruction, contributing to better results, an improved complication profile, and patient satisfaction.</p><p><strong>Level of evidence: 4 (therapeutic): </strong></p>","PeriodicalId":7728,"journal":{"name":"Aesthetic Surgery Journal","volume":" ","pages":"276-285"},"PeriodicalIF":3.0,"publicationDate":"2025-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142805830","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Patient Satisfaction After 3D Nipple-Areolar Complex Tattooing: A Case Series of Hispanic Women Following Breast Reconstruction Surgery.","authors":"Miguel Alexander Cálix Garcia, Israel Salazar Vizuet, Juan Manuel Melchor González, Carlos Godofredo Escobar Rivera, Guillermo Ernesto Alvarenga Funes, Martha María Sorto Figueroa","doi":"10.1093/asj/sjae235","DOIUrl":"10.1093/asj/sjae235","url":null,"abstract":"<p><strong>Background: </strong>Breast cancer is a prevalent cancer worldwide, leading many women to undergo mastectomy and breast reconstruction surgery. Nipple-areolar complex (NAC) reconstruction is critical in achieving aesthetic and psychological satisfaction. Recently, 3-dimensional (3D) NAC tattooing has become an option for this purpose.</p><p><strong>Objectives: </strong>The aim of this study was to evaluate patient-reported outcomes for satisfaction among Hispanic women who underwent NAC reconstruction with 3D tattooing after breast reconstruction.</p><p><strong>Methods: </strong>Data were collected from a retrospective database covering a number of academic settings between 2014 and 2024. Participants were Hispanic women aged 32 to 60 years who had undergone various NAC reconstruction techniques. Follow-up was conducted no more than 6 months after surgery, utilizing the BREAST-Q version 2.0 questionnaire to measure satisfaction in 2 groups: Group 1, in which patients received alternative NAC reconstruction methods; and Group 2, which received 3D NAC tattooing.</p><p><strong>Results: </strong>Patients who underwent 3D NAC tattooing (Group 2) demonstrated increased psychosocial well-being, with a mean [standard deviation] score of 84.73 [8.56]. Regarding surgeon experience, Group 2 achieved a mean score of 86.21 [10.33], which was lower than the Group 1 mean of 88.70 [10.78]. Notably, Group 2 expressed greater satisfaction with nipple reconstruction, with a mean score of 3.73 [0.44] compared with the Group 1 mean score of 3.48 [0.65].</p><p><strong>Conclusions: </strong>The findings indicate that 3D NAC tattooing may enhance aesthetic outcomes of the NAC and psychosocial well-being in Hispanic women. This highlights the importance of incorporating unique techniques in breast reconstruction and the need for a multidisciplinary approach.</p><p><strong>Level of evidence: 4 (therapeutic): </strong></p>","PeriodicalId":7728,"journal":{"name":"Aesthetic Surgery Journal","volume":" ","pages":"271-275"},"PeriodicalIF":3.0,"publicationDate":"2025-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142737982","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Gliding Brow Lift: An Analysis of Outcomes and Maintenance of Lift in a Single Surgeon's Practice.","authors":"Susan Orra, Madeline Bald, Grant Wagner, James C Grotting","doi":"10.1093/asj/sjae224","DOIUrl":"10.1093/asj/sjae224","url":null,"abstract":"<p><strong>Background: </strong>Efforts in brow lifting longevity, desire for minimally invasive procedures, patient individualization, and minimization of complications led to the development of the gliding brow lift (GBL). The GBL has proven to be a successful, minimally invasive technique targeting brow elevation in combination with the hemostatic net.</p><p><strong>Objectives: </strong>The aim of this study was to evaluate maintenance of cutaneous brow elevation with the GBL technique at specific postoperative time points.</p><p><strong>Methods: </strong>A retrospective review was conducted of 63 patients (59 females, 4 males) who underwent a GBL by J.C.G. between 2019 and 2022 for comorbidities, maintenance of brow lift, and incidence of complications at 4 postoperative time points: 3, 6, 9, and 12 months. Preoperative and postoperative photographs were analyzed at 4 anatomic locations: the supraorbital rim, lateral canthus, midpupil, and medial canthus.</p><p><strong>Results: </strong>The cohort consisted of 59 female-only patients; male patients were excluded due to small sample size. The average age was 62.8 years old (SD ±7.01) and the mean BMI was 24. Only 1 patient required return to the operating room for hematoma evacuation; this was a result of a concomitant rhytidectomy and did not involve the brow. All locations maintained a statistically significant lift (P < .01). The most significant lift was at the lateral canthus (3.09 mm) and tail of the brow (2.74 mm) at 1 year postoperatively.</p><p><strong>Conclusions: </strong>The GBL is a successful innovation in aesthetic brow surgery. Depending on patient needs, it is an excellent choice for selective and long-term elevation of the lateral brow.</p><p><strong>Level of evidence: 4 (therapeutic): </strong></p>","PeriodicalId":7728,"journal":{"name":"Aesthetic Surgery Journal","volume":" ","pages":"225-231"},"PeriodicalIF":3.0,"publicationDate":"2025-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142563666","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"IncobotulinumtoxinA in the Treatment of Upper Facial Lines: Results From Two Randomized, Double-Blind, Placebo-Controlled, Phase III Studies.","authors":"John Joseph, Vladimir Sudimac, Sabine Mersmann, Martina Kerscher","doi":"10.1093/asj/sjae222","DOIUrl":"10.1093/asj/sjae222","url":null,"abstract":"<p><strong>Background: </strong>Two randomized, double-blind, placebo-controlled, Phase III studies of incobotulinumtoxinA for treating upper facial lines (UFLs; ie, a combination of glabellar frown lines [GFLs], horizontal forehead lines [HFLs], and lateral canthal lines [LCLs]) were conducted in the United States (ULTRA I: NCT04594213) and Germany (ULTRA II: NCT04622254).</p><p><strong>Objectives: </strong>The aim of this study was to evaluate the safety and efficacy of simultaneous intramuscular injections for UFLs. Longer-term safety and efficacy were assessed in open-label extension periods.</p><p><strong>Methods: </strong>Healthy participants (≥18 years) with moderate-to-severe GFLs, HFLs, and symmetric LCLs at maximum contraction on the 5-point Merz Aesthetics Scales were randomized 2:1:1 to receive up to 64 units of incobotulinumtoxinA in the main period for each trial. Treatment groups were: UFLs, GFLs, and HFLs (ULTRA I), LCLs (ULTRA II), and placebo. Primary efficacy endpoints were the proportions of GFL, HFL, and LCL responders, defined as a Merz Aesthetics Scale score for the respective area of 0 (no) or 1 (mild) and a ≥2-grade improvement from baseline to Day 30, as assessed by both investigator and participant.</p><p><strong>Results: </strong>Overall, 362 and 368 participants received treatment in ULTRA I and ULTRA II, respectively. In both studies, incobotulinumtoxinA treatment was significantly more effective than placebo with respect to the primary endpoints (P < .0001) and key secondary endpoints (P < .0001). The open-label extension period results were consistent with those seen in the main period. No new safety findings were identified.</p><p><strong>Conclusions: </strong>In ULTRA I and ULTRA II, the safety and efficacy of incobotulinumtoxinA for the simultaneous treatment of moderate-to-severe UFLs were demonstrated, with significant improvements across all primary and secondary endpoints vs placebo.</p><p><strong>Level of evidence: 1 (therapeutic): </strong></p>","PeriodicalId":7728,"journal":{"name":"Aesthetic Surgery Journal","volume":" ","pages":"293-304"},"PeriodicalIF":3.0,"publicationDate":"2025-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11834979/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142543152","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Measuring Outcomes Relevant to the Décolletage From the Patient Perspective: Development and Validation of the BODY-Q Décolletage Scale.","authors":"Anne F Klassen, Charlene Rae, Andrea L Pusic, Manraj Kaur","doi":"10.1093/asj/sjae229","DOIUrl":"10.1093/asj/sjae229","url":null,"abstract":"<p><strong>Background: </strong>A range of cosmetic treatments to improve skin quality of the décolletage are available. To measure outcomes from the patient perspective, a rigorously developed patient-reported outcome measure (PROM) is needed.</p><p><strong>Objectives: </strong>The aim of this study was to develop and validate the BODY-Q Décolletage scale.</p><p><strong>Methods: </strong>Appearance-related codes from BODY-Q concept elicitation interviews were re-examined and 13 items drafted and refined through qualitative interviews with patients and clinicians. The scale was tested in an online international sample of women aged ≥25 years who had previously received a treatment for the décolletage, or in the past 12 months had received a cosmetic treatment at a plastic surgery or dermatology clinic. Data were analysed with both Rasch measurement theory and classical test theory. Construct validity involved testing 20 hypotheses. Convergent validity tests included correlations between the décolletage scale and other BODY-Q scales and the SKIN-Q.</p><p><strong>Results: </strong>Interviews conducted with 15 patients and 5 clinicians led to a 16-item scale with items that covered scenarios (mirror, photographs, low neckline, lay on side, breasts together, arms crossed, get up, up close), comparisons (with other people), age concerns (youthful, age), qualitative concerns (attractive, healthy), skin tone (even-colored), and texture (smooth, texture). The field test included 334 participants. An item with poor fit to the Rasch model was dropped. Data for the remaining 15 items fit the Rasch model (χ2 = 76.72, df = 60, P = .07). All items had ordered thresholds and good item fit. All reliability statistics were >0.93. A total of 19 of 20 predefined hypotheses (95%) were met, providing evidence of construct validity.</p><p><strong>Conclusions: </strong>The BODY-Q Décolletage scale is available to incorporate the perspective of patients into clinical care and clinical trials of minimally invasive treatments to improve skin quality.</p>","PeriodicalId":7728,"journal":{"name":"Aesthetic Surgery Journal","volume":" ","pages":"313-320"},"PeriodicalIF":3.0,"publicationDate":"2025-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11834981/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142612617","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Microfocused Ultrasound With Visualization (MFU-V) Effectiveness and Safety: A Systematic Review and Meta-Analysis.","authors":"Mojgan Amiri, Guardmond Ajasllari, Adea Llane, Gabriela Casabona, Tatjana Pavicic, Julia Sevi, Julieta Spada, Vasanop Vachiramon, Rossana Vasconcelos, Siew Tuck Wah, Taulant Muka, Sabrina Guillen Fabi","doi":"10.1093/asj/sjae228","DOIUrl":"10.1093/asj/sjae228","url":null,"abstract":"<p><p>Microfocused ultrasound with visualization (MFU-V) is an advanced, noninvasive cosmetic procedure widely performed for skin lifting and tightening. We performed a systematic review and meta-analysis to evaluate the aesthetic effectiveness, patient satisfaction, skin quality, and safety profile of MFU-V treatment. A comprehensive search of 5 bibliographic databases up to 2023 was conducted. Pooled effect estimates with random effects models and corresponding 95% confidence intervals were calculated. Out of 4019 references, 42 studies were included. Meta-analysis showed 89% of patients (95% CI: 81%-94%; I2: 63%, n = 411) demonstrated some degree of global aesthetic improvement, as assessed by investigators. Similarly, 84% of patients (95% CI: 73%-91%; I2: 64%, n = 312) reported improvement following treatment. Satisfaction of any level was reported by 84% of patients (95% CI: 61%-94%; I²: 52%, n = 326), and 62% (95% CI: 37%-82%; I²: 3%, n = 172) when \"neutral\" as a response option was provided for patients. Skin quality (eg, wrinkles, texture) also improved. Patients reported a pooled mean pain score of 4.85 (95% CI: 4.35, 5.35; I2: 97%, n = 785), indicating moderate pain. Common adverse events included erythema, edema, swelling, bruising, and tenderness, all of which were generally mild to moderate in severity. Overall, our analysis demonstrated a notable increase in global aesthetic improvement and patient satisfaction following MFU-V treatment, accompanied by moderate pain and a generally favorable safety profile. However, the potential misclassification of neutral responses as positive may result in an overestimation of the treatment's efficacy. These findings highlight the need for well-designed trials to further explore MFU-V's clinical applications.</p><p><strong>Level of evidence: 3 (therapeutic): </strong></p>","PeriodicalId":7728,"journal":{"name":"Aesthetic Surgery Journal","volume":" ","pages":"NP86-NP94"},"PeriodicalIF":3.0,"publicationDate":"2025-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11834976/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142612620","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}