Andreas Nikolis, Kaitlyn M Enright, Quynh Nguyen, Hani H Sinno, Sebastian Cotofana
{"title":"一项前瞻性临床试验评估非动物稳定透明质酸注射液用于非手术鼻成形术的疗效和安全性","authors":"Andreas Nikolis, Kaitlyn M Enright, Quynh Nguyen, Hani H Sinno, Sebastian Cotofana","doi":"10.1177/22925503231184263","DOIUrl":null,"url":null,"abstract":"<p><p><b>Background:</b> Non-surgical rhinoplasty with hyaluronic acid (HA) filler is a three-dimensional reshaping technique that achieves tissue enhancement by placing HA deep to nasal skin. Due to its unique rheology, Restylane® Lyft (HA-L, Galderma, Uppsala, Sweden) may be particularly well-suited for injection rhinoplasty, as it has high gel firmness (G') for strong structural support with minimal integration propensity. <b>Methods:</b> A prospective clinical trial was conducted to evaluate HA-L use for non-surgical rhinoplasty. Thirty-three females were observed over eight months, using the following schedule: Visit 1 = Baseline/Treatment 1; Visit 2 = Optional touch up (Week 2); Visits 3-6 = Follow-ups (Months 1,3,6,8). The primary endpoint was subject improvement at Month 1 assessed by a blinded evaluator using the Global Aesthetic Improvement Scale (GAIS). Subject satisfaction and adverse events (AEs) were also evaluated. <b>Results:</b> A deep, periosteal injection using a bolus technique and 0.34 cc of HA-L was most often used. Seven cases of positive aspiration occurred in 167 injection points (4.19%), among 6/33 (18.18%) subjects. Based on the GAIS, 100% of subjects met the primary endpoint. Subject satisfaction was maximal at Month 1 (100%) and largely maintained at Month 8 (78.57%). Besides expected injection-related AEs (eg, ecchymosis, erythema), immediate AEs during/following treatment were limited to presyncopal symptoms [5/33 subjects (15.15%)]. Importantly, no cases of ischemia were observed. Subject-reported AEs (eg, swelling, erythema, pain) dissipated within 2 to 7 days. <b>Conclusion:</b> Given the technical nature of this technique, HA-L may be well-suited for injection rhinoplasty, due to its strong safety and efficacy profile. <b>Level of Evidence:</b> Level III: Evidence obtained from well-designed cohort study.</p>","PeriodicalId":20206,"journal":{"name":"Plastic surgery","volume":" ","pages":"97-106"},"PeriodicalIF":0.7000,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11773380/pdf/","citationCount":"0","resultStr":"{\"title\":\"A Prospective Clinical Trial Evaluating the Efficacy and Safety of Non-Animal Stabilized Hyaluronic Acid Injections for Non-Surgical Rhinoplasty.\",\"authors\":\"Andreas Nikolis, Kaitlyn M Enright, Quynh Nguyen, Hani H Sinno, Sebastian Cotofana\",\"doi\":\"10.1177/22925503231184263\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p><b>Background:</b> Non-surgical rhinoplasty with hyaluronic acid (HA) filler is a three-dimensional reshaping technique that achieves tissue enhancement by placing HA deep to nasal skin. Due to its unique rheology, Restylane® Lyft (HA-L, Galderma, Uppsala, Sweden) may be particularly well-suited for injection rhinoplasty, as it has high gel firmness (G') for strong structural support with minimal integration propensity. <b>Methods:</b> A prospective clinical trial was conducted to evaluate HA-L use for non-surgical rhinoplasty. Thirty-three females were observed over eight months, using the following schedule: Visit 1 = Baseline/Treatment 1; Visit 2 = Optional touch up (Week 2); Visits 3-6 = Follow-ups (Months 1,3,6,8). The primary endpoint was subject improvement at Month 1 assessed by a blinded evaluator using the Global Aesthetic Improvement Scale (GAIS). Subject satisfaction and adverse events (AEs) were also evaluated. <b>Results:</b> A deep, periosteal injection using a bolus technique and 0.34 cc of HA-L was most often used. Seven cases of positive aspiration occurred in 167 injection points (4.19%), among 6/33 (18.18%) subjects. Based on the GAIS, 100% of subjects met the primary endpoint. Subject satisfaction was maximal at Month 1 (100%) and largely maintained at Month 8 (78.57%). Besides expected injection-related AEs (eg, ecchymosis, erythema), immediate AEs during/following treatment were limited to presyncopal symptoms [5/33 subjects (15.15%)]. Importantly, no cases of ischemia were observed. Subject-reported AEs (eg, swelling, erythema, pain) dissipated within 2 to 7 days. <b>Conclusion:</b> Given the technical nature of this technique, HA-L may be well-suited for injection rhinoplasty, due to its strong safety and efficacy profile. <b>Level of Evidence:</b> Level III: Evidence obtained from well-designed cohort study.</p>\",\"PeriodicalId\":20206,\"journal\":{\"name\":\"Plastic surgery\",\"volume\":\" \",\"pages\":\"97-106\"},\"PeriodicalIF\":0.7000,\"publicationDate\":\"2025-02-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11773380/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Plastic surgery\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1177/22925503231184263\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2023/7/12 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q4\",\"JCRName\":\"SURGERY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Plastic surgery","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/22925503231184263","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2023/7/12 0:00:00","PubModel":"Epub","JCR":"Q4","JCRName":"SURGERY","Score":null,"Total":0}
A Prospective Clinical Trial Evaluating the Efficacy and Safety of Non-Animal Stabilized Hyaluronic Acid Injections for Non-Surgical Rhinoplasty.
Background: Non-surgical rhinoplasty with hyaluronic acid (HA) filler is a three-dimensional reshaping technique that achieves tissue enhancement by placing HA deep to nasal skin. Due to its unique rheology, Restylane® Lyft (HA-L, Galderma, Uppsala, Sweden) may be particularly well-suited for injection rhinoplasty, as it has high gel firmness (G') for strong structural support with minimal integration propensity. Methods: A prospective clinical trial was conducted to evaluate HA-L use for non-surgical rhinoplasty. Thirty-three females were observed over eight months, using the following schedule: Visit 1 = Baseline/Treatment 1; Visit 2 = Optional touch up (Week 2); Visits 3-6 = Follow-ups (Months 1,3,6,8). The primary endpoint was subject improvement at Month 1 assessed by a blinded evaluator using the Global Aesthetic Improvement Scale (GAIS). Subject satisfaction and adverse events (AEs) were also evaluated. Results: A deep, periosteal injection using a bolus technique and 0.34 cc of HA-L was most often used. Seven cases of positive aspiration occurred in 167 injection points (4.19%), among 6/33 (18.18%) subjects. Based on the GAIS, 100% of subjects met the primary endpoint. Subject satisfaction was maximal at Month 1 (100%) and largely maintained at Month 8 (78.57%). Besides expected injection-related AEs (eg, ecchymosis, erythema), immediate AEs during/following treatment were limited to presyncopal symptoms [5/33 subjects (15.15%)]. Importantly, no cases of ischemia were observed. Subject-reported AEs (eg, swelling, erythema, pain) dissipated within 2 to 7 days. Conclusion: Given the technical nature of this technique, HA-L may be well-suited for injection rhinoplasty, due to its strong safety and efficacy profile. Level of Evidence: Level III: Evidence obtained from well-designed cohort study.
期刊介绍:
Plastic Surgery (Chirurgie Plastique) is the official journal of the Canadian Society of Plastic Surgeons, the Canadian Society for Aesthetic Plastic Surgery, Group for the Advancement of Microsurgery, and the Canadian Society for Surgery of the Hand. It serves as a major venue for Canadian research, society guidelines, and continuing medical education.