Céline Lheritier, Sophie Converset, Berthold-Josef Rzany, Hugues Cartier, Benjamin Ascher
{"title":"新型透明质酸皮肤填充剂对鼻唇沟矫正的功效:前瞻性、对比性、双盲临床试验。","authors":"Céline Lheritier, Sophie Converset, Berthold-Josef Rzany, Hugues Cartier, Benjamin Ascher","doi":"10.1097/DSS.0000000000004207","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Hyaluronic acid-based dermal fillers are the cornerstones of wrinkle correction and facial contour redefinition.</p><p><strong>Objective: </strong>To assess the efficacy and safety of EST LF compared with RES L for the treatment of nasolabial folds (NLFs).</p><p><strong>Materials and methods: </strong>In this prospective, split-face, randomized, investigator and subject-blinded trial, 45 subjects with moderate-to-severe symmetrical NLFs were randomized to EST LF on one side of the face and RES L on the other side and were followed up for 9 months. The primary end point was change in WSRS score from the baseline to Month 1 (M1). Secondary end points included changes in WSRS score at other time points, aesthetic improvement, wrinkle volume quantification, adverse events, and local tolerance.</p><p><strong>Results: </strong>The efficacy difference between EST LF and RES L at M1 was in favor of EST LF (-0.16, CI, -0.28 to -0.03]), demonstrating its noninferiority. Considering other time points, significant differences were observed at 3 and 6 months for EST LF , assessed with WSRS, GAIS, or NLF volume quantification. Both treatments were well tolerated.</p><p><strong>Conclusion: </strong>EST LF is effective and well tolerated for the treatment of NLFs.</p>","PeriodicalId":11289,"journal":{"name":"Dermatologic Surgery","volume":null,"pages":null},"PeriodicalIF":2.5000,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11288387/pdf/","citationCount":"0","resultStr":"{\"title\":\"Efficacy of a New Hyaluronic Acid Dermal Filler on Nasolabial Folds Correction: A Prospective, Comparative, Double-Blinded Clinical Trial.\",\"authors\":\"Céline Lheritier, Sophie Converset, Berthold-Josef Rzany, Hugues Cartier, Benjamin Ascher\",\"doi\":\"10.1097/DSS.0000000000004207\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Hyaluronic acid-based dermal fillers are the cornerstones of wrinkle correction and facial contour redefinition.</p><p><strong>Objective: </strong>To assess the efficacy and safety of EST LF compared with RES L for the treatment of nasolabial folds (NLFs).</p><p><strong>Materials and methods: </strong>In this prospective, split-face, randomized, investigator and subject-blinded trial, 45 subjects with moderate-to-severe symmetrical NLFs were randomized to EST LF on one side of the face and RES L on the other side and were followed up for 9 months. The primary end point was change in WSRS score from the baseline to Month 1 (M1). Secondary end points included changes in WSRS score at other time points, aesthetic improvement, wrinkle volume quantification, adverse events, and local tolerance.</p><p><strong>Results: </strong>The efficacy difference between EST LF and RES L at M1 was in favor of EST LF (-0.16, CI, -0.28 to -0.03]), demonstrating its noninferiority. Considering other time points, significant differences were observed at 3 and 6 months for EST LF , assessed with WSRS, GAIS, or NLF volume quantification. Both treatments were well tolerated.</p><p><strong>Conclusion: </strong>EST LF is effective and well tolerated for the treatment of NLFs.</p>\",\"PeriodicalId\":11289,\"journal\":{\"name\":\"Dermatologic Surgery\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":2.5000,\"publicationDate\":\"2024-08-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11288387/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Dermatologic Surgery\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1097/DSS.0000000000004207\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/5/7 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q2\",\"JCRName\":\"DERMATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Dermatologic Surgery","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1097/DSS.0000000000004207","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/5/7 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"DERMATOLOGY","Score":null,"Total":0}
Efficacy of a New Hyaluronic Acid Dermal Filler on Nasolabial Folds Correction: A Prospective, Comparative, Double-Blinded Clinical Trial.
Background: Hyaluronic acid-based dermal fillers are the cornerstones of wrinkle correction and facial contour redefinition.
Objective: To assess the efficacy and safety of EST LF compared with RES L for the treatment of nasolabial folds (NLFs).
Materials and methods: In this prospective, split-face, randomized, investigator and subject-blinded trial, 45 subjects with moderate-to-severe symmetrical NLFs were randomized to EST LF on one side of the face and RES L on the other side and were followed up for 9 months. The primary end point was change in WSRS score from the baseline to Month 1 (M1). Secondary end points included changes in WSRS score at other time points, aesthetic improvement, wrinkle volume quantification, adverse events, and local tolerance.
Results: The efficacy difference between EST LF and RES L at M1 was in favor of EST LF (-0.16, CI, -0.28 to -0.03]), demonstrating its noninferiority. Considering other time points, significant differences were observed at 3 and 6 months for EST LF , assessed with WSRS, GAIS, or NLF volume quantification. Both treatments were well tolerated.
Conclusion: EST LF is effective and well tolerated for the treatment of NLFs.
期刊介绍:
Exclusively devoted to dermatologic surgery, the Dermatologic Surgery journal publishes the most clinically comprehensive and up-to-date information in its field. This unique monthly journal provides today’s most expansive and in-depth coverage of cosmetic and reconstructive skin surgery and skin cancer through peer-reviewed original articles, extensive illustrations, case reports, ongoing features, literature reviews and correspondence. The journal provides information on the latest scientific information for all types of dermatologic surgery including:
-Ambulatory phlebectomy-
Blepharoplasty-
Body contouring-
Chemical peels-
Cryosurgery-
Curettage and desiccation-
Dermabrasion-
Excision and closure-
Flap Surgery-
Grafting-
Hair restoration surgery-
Injectable neuromodulators-
Laser surgery-
Liposuction-
Microdermabrasion-
Microlipoinjection-
Micropigmentation-
Mohs micrographic surgery-
Nail surgery-
Phlebology-
Sclerotherapy-
Skin cancer surgery-
Skin resurfacing-
Soft-tissue fillers.
Dermatologists, dermatologic surgeons, plastic surgeons, oculoplastic surgeons and facial plastic surgeons consider this a must-read publication for anyone in the field.