Xing Wang, Fu-Jin Liu, Chun-Lin Chen, Jia-Ying Xu, Zhong-Sheng Sun, Chen Dong, Guo-Hao Yuan, Li Ma, Hai-Bin Wang
{"title":"Retrospective Study on Palpable Indurations After Cosmetic Filler Injection: Ultrasonic Characterization and Image-guided Therapy.","authors":"Xing Wang, Fu-Jin Liu, Chun-Lin Chen, Jia-Ying Xu, Zhong-Sheng Sun, Chen Dong, Guo-Hao Yuan, Li Ma, Hai-Bin Wang","doi":"10.1093/asj/sjag061","DOIUrl":"https://doi.org/10.1093/asj/sjag061","url":null,"abstract":"<p><strong>Background: </strong>Minimally invasive filler injections are prevalent in aesthetic medicine. However, in recent years, the occurrence of complications has gradually increased. Current management lacks standardization, necessitating reliable imaging for diagnosis and treatment guidance.</p><p><strong>Objectives: </strong>This study aimed to evaluate the diagnostic value of high-frequency ultrasound in filler-induced indurations and explore its significance in guiding treatment strategy selection.</p><p><strong>Methods: </strong>A retrospective analysis included 231 patients with indurations after filler injection (January 2023-June 2025). All underwent high-frequency ultrasound(12-18MHz); 70 received pathological biopsy. Biopsy was used to determine the nature of the lesions and establish the correlation between lesion type and sonographic features. Based on ultrasound characteristics, lesions were classified into 7 types, and analyze the accuracy of ultrasound diagnosis and the efficacy of different treatment methods.</p><p><strong>Results: </strong>The ultrasound-pathology concordance rate was 85.7%. The most common complications were accumulation of non-HA fillers (37.2%) and granuloma with non-HA fillers (22.5%). Non-HA filler granuloma responded better to non-invasive treatment (P<0.001), while granuloma without residual filler and HA with granuloma favored invasive treatment (P=0.001). Invasive treatment showed greater improvement in indurations (P<0.001).</p><p><strong>Conclusions: </strong>High-frequency ultrasound accurately identifies types of complication, providing crucial evidence for individualized treatment selection.</p>","PeriodicalId":7728,"journal":{"name":"Aesthetic Surgery Journal","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2026-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147669818","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":"Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL): Comparison of Manufacturers From UK National Data.","authors":"Richard Goodall, Simon Wood","doi":"10.1093/asj/sjaf190","DOIUrl":"10.1093/asj/sjaf190","url":null,"abstract":"","PeriodicalId":7728,"journal":{"name":"Aesthetic Surgery Journal","volume":" ","pages":"NP45-NP46"},"PeriodicalIF":3.0,"publicationDate":"2026-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145124135","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}
Andreas Nikolis, Andrei Metelitsa, Laura Raco, Tyler Safran
{"title":"Safety and Effectiveness of Two High-G' Soft Tissue Fillers for Chin Augmentation: A Prospective, Randomized, Comparator-Controlled, Evaluator-Blinded Trial.","authors":"Andreas Nikolis, Andrei Metelitsa, Laura Raco, Tyler Safran","doi":"10.1093/asj/sjaf222","DOIUrl":"10.1093/asj/sjaf222","url":null,"abstract":"<p><strong>Background: </strong>The chin is a crucial facial feature for overall attractiveness. Lower third imbalance can lead to signs of premature aging and loss of jawline contour. Effective chin augmentation with hyaluronic acid fillers has been demonstrated in the literature. Currently, however, no study has compared the safety and effectiveness of two high-G' fillers.</p><p><strong>Objectives: </strong>The objective of this study was to examine each filler's effectiveness in the correction of chin retrusion through a prospective, randomized, comparator-controlled, evaluator-blinded trial.</p><p><strong>Methods: </strong>This study compared the safety and effectiveness of HASHA (Restylane Shaype) vs HAVLX (Juvederm Volux) for chin augmentation and correction of chin retrusion. A prospective, randomized, comparator-controlled, evaluator-blinded trial was conducted at a single research center. Forty participants aged 18 years or older with mild to severe chin retrusion were included and randomly allocated 1:1 to either HASHA (n = 20) or HAVLX (n = 20). The primary study endpoint was to examine differences in parameters associated with determining chin shape. Secondary endpoints included adverse events and patient satisfaction.</p><p><strong>Results: </strong>Of the 40 participants enrolled in the trial, 37 (92.5%) were female and 3 (7.5%) were male. Although an independent-samples t-test revealed no statistically significant difference in total volumes of filler used with HAVLX (mean [standard deviation], 1.85 [0.69] mL) or HASHA (mean, 1.86 [0.89] mL, P = .953). When focused on the menton/pogonion injections, HAVLX required 15.27% more product than HASHA (mean, 1.48 mL vs 1.27 mL, P = .28). There was a statistically significant difference in efficiency score for correcting labiomental angle, with the mean efficiency score being 2.57 [1.67] for HASHA and 1.50 [1.11] for HAVLX (P = .02).</p><p><strong>Conclusions: </strong>With no statistically significant difference in overall volume utilized between HASHA and HAVLX, HASHA injections required 15.27% less volume in the menton/pogonion to achieve visual correction. Additionally, HASHA demonstrated a significantly higher efficiency score for correction of nasomental angle. Secondary endpoints were not significantly different and demonstrate that both products are safe and effective.</p><p><strong>Level of evidence: 2 (therapeutic): </strong></p>","PeriodicalId":7728,"journal":{"name":"Aesthetic Surgery Journal","volume":" ","pages":"503-508"},"PeriodicalIF":3.0,"publicationDate":"2026-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13064664/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145494222","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}
Y Edward Wen, Lucas R Perez Rivera, Hailey P Wyatt, Wen-Yu Lee, Cheongeun Oh, Carter J Boyd, Nolan S Karp
{"title":"Efficacy and Safety of Hyaluronic Acid Lip Fillers: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.","authors":"Y Edward Wen, Lucas R Perez Rivera, Hailey P Wyatt, Wen-Yu Lee, Cheongeun Oh, Carter J Boyd, Nolan S Karp","doi":"10.1093/asj/sjaf224","DOIUrl":"10.1093/asj/sjaf224","url":null,"abstract":"<p><p>Despite the growing demand for hyaluronic acid (HA) lip fillers, there is a paucity of robust, quantitative data across high-powered studies. This systematic review and meta-analysis aims to assess the efficacy and safety of HA lip fillers as reported by randomized controlled trials (RCTs). A systematic review was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses 2020 guidelines, utilizing PubMed, Embase, and Cochrane, and eligible studies included RCTs with human participants utilizing HA filler for lip augmentation. Meta-analysis evaluated rates of improvement in lip fullness, aesthetic appearance, patient satisfaction, and adverse events. A comprehensive review initially identified 2038 articles. Following screening by title and abstract, full-text review, and risk of bias assessment with the Cochrane risk-of-bias tool for randomized trials, 16 articles were included in the study. Meta-analysis demonstrated that 60% (95% CI, 44%-76%) had improvement in lip fullness, 82% (95% CI, 67%-92%) had improvement in aesthetic appearance, 68% (95% CI, 58%-78%) reported satisfaction, 50% (95% CI, 27%-73%) had adverse events, and 1.1% (95% CI, 1.9-4.0%) had serious adverse events requiring treatment, needing follow-up, or lasting beyond 30 days. The most common adverse events were swelling (78%), firmness (48%), bruising (34%), and tenderness (33%). Across studies with the highest level of evidence, HA filler efficacy and patient satisfaction was moderate to high. Severe adverse reactions were rare, but adverse events were common. Level of Evidence: 1 (Therapeutic).</p>","PeriodicalId":7728,"journal":{"name":"Aesthetic Surgery Journal","volume":" ","pages":"NP24-NP32"},"PeriodicalIF":3.0,"publicationDate":"2026-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145436809","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":"Cosmetic Medicine and Aesthetic Surgery Journal: The Beautiful Bond Between Noninvasive Aesthetic Medicine and Plastic Surgery.","authors":"Julius W Few, Sachin M Shridharani","doi":"10.1093/asj/sjag014","DOIUrl":"10.1093/asj/sjag014","url":null,"abstract":"","PeriodicalId":7728,"journal":{"name":"Aesthetic Surgery Journal","volume":"46 5","pages":"461-465"},"PeriodicalIF":3.0,"publicationDate":"2026-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13064642/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147643632","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}
Yan Wu, Benjamin Ascher, Zhiyong Yang, Hongsen Bi, Li Li, Hongyi Zhao, Hang Wang, Jinming Zhang, Sheng-Kang Luo
{"title":"Effectiveness and Safety of a Cross-linked Hyaluronic Acid Plus Mannitol Filler for the Correction of Nasolabial Folds in Chinese Subjects: A Randomized, Blinded, Controlled Study.","authors":"Yan Wu, Benjamin Ascher, Zhiyong Yang, Hongsen Bi, Li Li, Hongyi Zhao, Hang Wang, Jinming Zhang, Sheng-Kang Luo","doi":"10.1093/asj/sjaf186","DOIUrl":"10.1093/asj/sjaf186","url":null,"abstract":"<p><strong>Background: </strong>Hyaluronic acid-based dermal fillers are commonly used to correct prominent nasolabial folds (NLFs), a hallmark of aging.</p><p><strong>Objectives: </strong>This study aimed to verify the effectiveness and safety of STYLAGE L filler (Laboratoires VIVACY, Archamps, France) vs a well-established comparator, Restylane (Galderma, Uppsala, Sweden), for correcting moderate-to-severe NLFs in Chinese subjects.</p><p><strong>Methods: </strong>A 12-month, randomized, subject- and evaluator-blinded, controlled, parallel-group, noninferiority study was conducted across 8 hospitals in China. The primary endpoint was the percentage of Wrinkle Severity Rating Scale (WSRS) responders 6 months after last treatment. Secondary endpoints included Global Aesthetic Improvement Scale (GAIS) responders, subject satisfaction, device performance, and tolerance.</p><p><strong>Results: </strong>In total, 194 and 196 subjects were randomly allocated to the treatment (STYLAGE L) and control (Restylane) groups, respectively, and analyzed. In the primary endpoint analysis, noninferiority of STYLAGE L was demonstrated because the lower limit of the 95% CI was greater than -10% (difference in percentage of responders, 9.33%; 95% CI, 2.10%-16.56%). WSRS responder rates were statistically significantly higher in the treatment compared with the control group at 6 months (9.19%; 95% CI, 1.85%-16.54%; P = .0157), 9 months (19.75%; 95% CI, 10.97%-28.53%; P < .0001), and 12 months (11.36%; 95% CI, 2.64%-20.09%; P = .0116). GAIS responder rates were high in both groups throughout the study (>73%). Subject satisfaction was high. Both devices were well tolerated. Device performance scores were statistically significantly higher (ie, aspects were \"harder\") for STYLAGE L vs Restylane.</p><p><strong>Conclusions: </strong>The study demonstrated the noninferiority of STYLAGE L vs Restylane in correcting NLFs in Chinese subjects. Results up to 12 months suggest comparable safety and effectiveness profiles.</p><p><strong>Level of evidence: 1 (therapeutic): </strong></p>","PeriodicalId":7728,"journal":{"name":"Aesthetic Surgery Journal","volume":" ","pages":"466-477"},"PeriodicalIF":3.0,"publicationDate":"2026-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13064651/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145147431","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}
Roshan Ravindran, Masoud Rahmati, José Francisco López-Gil, Dong Keon Yon, Damiano Pizzol, Julia Gawronska, Fiona Richardson, Helen Keyes, Yvonne Barnett, Laurie Butler, Lee Smith
{"title":"The Association Between Existing Health Conditions and Adverse Events From Botulinum Toxins: Findings From a UK Cross-sectional Survey in 2024.","authors":"Roshan Ravindran, Masoud Rahmati, José Francisco López-Gil, Dong Keon Yon, Damiano Pizzol, Julia Gawronska, Fiona Richardson, Helen Keyes, Yvonne Barnett, Laurie Butler, Lee Smith","doi":"10.1093/asj/sjaf217","DOIUrl":"10.1093/asj/sjaf217","url":null,"abstract":"<p><strong>Background: </strong>There is growing demand for Botulinum toxin (BoNT) injections in the UK. However, there is a scarcity of research in relation to associations between medical conditions and BoNT adverse events.</p><p><strong>Objectives: </strong>To investigate cross-sectional associations between existing medical conditions and the likelihood of adverse events in a large sample of UK BoNT users.</p><p><strong>Methods: </strong>A cross-sectional observational survey on individuals' (≥18 years) experiences and adverse events with cosmetic BoNT injections. Data were collected on participants age, gender, existing health conditions, acute and long-term adverse events following BoNT treatment. To investigate the association between pre-existing physical conditions and the occurrence of post-BoNT adverse effects, multivariable logistic regression models were performed.</p><p><strong>Results: </strong>Nine hundred and nineteen participants who received BoNT were included in the analysis. Multivariable logistic regression revealed that several pre-existing physical and psychiatric conditions were significantly associated with increased odds of specific post-BoNT adverse effects. Notably, individuals with skin disease (odds ratio [OR] 22.95, 95% confidence interval [CI] 2.64-132.03, P = .001), type 1 diabetes mellitus (OR 110.34, 95% CI 3.85-3381.06, P = .002), chronic migraine (OR 7.69, 95% CI 1.84-27.61, P = .003), and thyroid disorders (OR 6.18, 95% CI 1.27-23.44, P = .012) demonstrated significantly higher odds of developing nausea following BoNT administration. Multiple other significant associations were found between numerous existing health conditions and numerous adverse events.</p><p><strong>Conclusions: </strong>This study found that autoimmune, endocrine, neurological, and mental health comorbidities significantly increase the likelihood of adverse outcomes, ranging from bruising and ptosis to mood disturbance, neuromuscular weakness, and apparent treatment failure.</p><p><strong>Level of evidence 4 (therapeutic): </strong></p>","PeriodicalId":7728,"journal":{"name":"Aesthetic Surgery Journal","volume":" ","pages":"495-502"},"PeriodicalIF":3.0,"publicationDate":"2026-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145353458","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}
Mateusz Trzeciak, Marcin Lipski, Tomasz Gładysz, Artur Pasternak, Joe Iwanaga, Greg Bran, Mateusz Koziej, Jerzy Walocha
{"title":"Anatomical Depth of Labial Arteries in Dermal Filler Procedures: A Meta-analysis With Clinical Implications.","authors":"Mateusz Trzeciak, Marcin Lipski, Tomasz Gładysz, Artur Pasternak, Joe Iwanaga, Greg Bran, Mateusz Koziej, Jerzy Walocha","doi":"10.1093/asj/sjaf192","DOIUrl":"10.1093/asj/sjaf192","url":null,"abstract":"<p><p>Lip augmentation procedures are increasingly popular in aesthetic medicine, and precise knowledge of labial arterial anatomy is essential for safe outcomes. The superior labial artery (SLA) and inferior labial artery (ILA) serve as critical anatomical landmarks for these procedures, and their positioning guides injection techniques. But despite their importance, there has been uncertainty about the precise depths of these vessels across different facial regions, creating potential risks during procedures. Therefore, we conducted a comprehensive meta-analysis to quantitatively compare arterial depths at 3 distinct levels of the SLA and evaluate average depths of both the SLA and ILA. Analysis of multiple arterial measurements (277, 218, 252, 414, and 295 arteries) at key locations-between the cheilion and Cupid's bow peak, at the Cupid's bow peak, and at the facial midline-revealed consistent average depths ranging from 4.59 mm (95% CI, 3.91-5.10) to 4.90 mm (95% CI, 4.57-5.61). These findings demonstrate that the vessels maintain relatively consistent depth beneath the vermilion surface, supporting safe injection guidelines of up to 3.5 mm in most lip regions and up to 4 mm in the superior vermilion. Although the SLA and ILA showed similar average depths, practitioners should consider using high-resolution ultrasonography before extensive augmentation procedures for additional safety assurance. Level of Evidence: 3 (Therapeutic).</p>","PeriodicalId":7728,"journal":{"name":"Aesthetic Surgery Journal","volume":" ","pages":"478-485"},"PeriodicalIF":3.0,"publicationDate":"2026-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145129859","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}
Stafford Sansome, Mike Clague, Cormac Convery, Emma Davies, Catherine Fairris, Greg Goodman, Steven Harris, Elizabeth Hawkes, Gordon Hay, Gillian Murray, Sabrina Shah-Desai, Colin Vize, Lee Walker, James E Neffendorf
{"title":"Consensus Guidelines for the Management of Tissue Filler-Induced Vision Loss in the United Kingdom.","authors":"Stafford Sansome, Mike Clague, Cormac Convery, Emma Davies, Catherine Fairris, Greg Goodman, Steven Harris, Elizabeth Hawkes, Gordon Hay, Gillian Murray, Sabrina Shah-Desai, Colin Vize, Lee Walker, James E Neffendorf","doi":"10.1093/asj/sjag002","DOIUrl":"10.1093/asj/sjag002","url":null,"abstract":"<p><p>Worldwide, the use of soft tissue fillers for aesthetic purposes has significantly increased, as have the number of associated complications. Vision loss is a rare but catastrophic complication of injecting tissue fillers. We formed a UK multidisciplinary steering group in 2024 to develop consensus guidelines for the management of tissue filler-induced vision loss. The multidisciplinary steering group consisted of various specialists with significant expertise in aesthetics, emergency ophthalmology, oculoplastic surgery, and the retina. Consensus statements were formulated by the group. Recommendations focused on immediate emergency measures, access pathways to specialist care, improved consent processes, and increasing awareness of vision-related complications. These guidelines aim to provide pragmatic, evidence-based steps for frontline clinicians to optimize patient outcomes for this rare but devastating complication. Level of Evidence: 5 (Risk).</p>","PeriodicalId":7728,"journal":{"name":"Aesthetic Surgery Journal","volume":" ","pages":"563-568"},"PeriodicalIF":3.0,"publicationDate":"2026-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13064663/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145905359","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":"Safety and Effectiveness of a Crosslinked Hyaluronic Acid Filler in Korean Patients for the Correction of Nasolabial Folds: A Randomized, Patient- and Evaluator-Blinded, Paired Study.","authors":"Si-Hyung Lee, Eunsoo Park, Chong Hyun Won","doi":"10.1093/asj/sjag003","DOIUrl":"10.1093/asj/sjag003","url":null,"abstract":"<p><strong>Background: </strong>Hyaluronic acid (HA) dermal fillers are widely used as a nonsurgical treatment for facial aging, including nasolabial folds (NLFs). Because demand for convenient aesthetic procedures increases, new HA products require rigorous comparison with established fillers.</p><p><strong>Objectives: </strong>The aim of this study was to assess the noninferiority and safety of a new crosslinked HA filler, SkinPlus-HYAL Implant Lidocaine (test), vs RESTYLANE Lidocaine (control) for temporary correction of moderate to severe NLFs.</p><p><strong>Methods: </strong>In this multicenter, randomized, patient- and evaluator-blinded, split-face study, 100 adults with moderate or severe NLFs received the test filler in 1 NLF and the control in the contralateral NLF. Efficacy was analyzed in the full analysis set (n = 93). The primary endpoint was the between-treatment difference in Wrinkle Severity Rating Scale (WSRS) scores at Week 24. Safety was evaluated in the safety set (n = 100). Group differences were analyzed using a 2-sample t-test.</p><p><strong>Results: </strong>At Week 24, mean WSRS scores were 1.85 ± 0.72 (test) and 1.84 ± 0.68 (control). The mean difference (test - control) was 0.01 ± 0.48, with an upper 97.5% 1-sided confidence limit of 0.2136, below the prespecified noninferiority margin of 0.29. Investigator-rated Global Aesthetic Improvement Scale (GAIS) scores at Week 24 and patient-rated GAIS scores at Week 8 favored the test filler. Local adverse events were more frequent with the test (92.00%) than the control (82.0%), but severe injection-site reactions were uncommon, and no serious adverse events occurred.</p><p><strong>Conclusions: </strong>SkinPlus-HYAL Implant Lidocaine was noninferior to RESTYLANE Lidocaine for correction of moderate to severe NLFs and maintained efficacy through 48 weeks. Despite a higher rate of local reactions, its overall safety profile was acceptable, supporting its use as an effective, safe option for facial aesthetic augmentation.</p><p><strong>Level of evidence: 1 (therapeutic): </strong></p>","PeriodicalId":7728,"journal":{"name":"Aesthetic Surgery Journal","volume":" ","pages":"569-575"},"PeriodicalIF":3.0,"publicationDate":"2026-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13064636/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145931584","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}