Jiangmiao Xie, Yuwei Zhang, Nanze Yu, Wenyun Ting, Yanping Shi, Wei Zhang, Ling Tian, Lin Jin, Runzhu Liu, Ang Zeng, Xiao Long
{"title":"用于下巴修复的 Hyamax® Monophasic Volumizer 皮肤填充剂:前瞻性、单中心、研究者对照、随机对照试验。","authors":"Jiangmiao Xie, Yuwei Zhang, Nanze Yu, Wenyun Ting, Yanping Shi, Wei Zhang, Ling Tian, Lin Jin, Runzhu Liu, Ang Zeng, Xiao Long","doi":"10.1007/s00266-024-04489-x","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Hyamax® Monophasic Volumizer Dermal Fillers is a newly designed hyaluronic acid soft tissue filler for chin augmentation.</p><p><strong>Methods: </strong>A prospective, single-center, evaluator-blinded, randomized controlled study was designed to evaluate the effectiveness and safety of Hyamax® Volumizer in the correction of chin retrusion in the 18-55-year-old Chinese population for 12 months after treatment. Participants were randomized (3:1) to receive Hyamax® Volumizer injection (n = 21) or no treatment (n = 7). Assessments included live and blinded evaluations by photographs on a chin retrusion scale (Galderma Chin Retrusion Scale), aesthetic improvement (Global Aesthetic Improvement Scale) by the subjects and independent evaluators, and safety follow-up at 3, 6, 9, and 12 months.</p><p><strong>Results: </strong>Hyamax® Volumizer was superior in improving chin retrusion at 6 months with a GCRS response rate of 57.14% versus 0% of the controls (P<0.0001) meeting the primary effectiveness objective. The GCRS and GAIS scores by subjects and evaluators achieved remarkable improvement at all follow-up points compared with the control group through 12 months. Common ISRs were injection-site pain (90.48%), tenderness (80.95%), redness (47.62%) and ecchymosis (19.05%). No serious treatment-related advert events were reported.</p><p><strong>Conclusion: </strong>Hyamax® Volumizer significantly restored the facial volume and improved the chin projection with safety.</p><p><strong>Level of evidence i: </strong>This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .</p>","PeriodicalId":7609,"journal":{"name":"Aesthetic Plastic Surgery","volume":null,"pages":null},"PeriodicalIF":2.0000,"publicationDate":"2024-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Hyamax® Monophasic Volumizer Dermal Fillers for Chin Restoration: A Prospective, Single-Center, Investigator-Blinded, Randomized Controlled Trial.\",\"authors\":\"Jiangmiao Xie, Yuwei Zhang, Nanze Yu, Wenyun Ting, Yanping Shi, Wei Zhang, Ling Tian, Lin Jin, Runzhu Liu, Ang Zeng, Xiao Long\",\"doi\":\"10.1007/s00266-024-04489-x\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Hyamax® Monophasic Volumizer Dermal Fillers is a newly designed hyaluronic acid soft tissue filler for chin augmentation.</p><p><strong>Methods: </strong>A prospective, single-center, evaluator-blinded, randomized controlled study was designed to evaluate the effectiveness and safety of Hyamax® Volumizer in the correction of chin retrusion in the 18-55-year-old Chinese population for 12 months after treatment. Participants were randomized (3:1) to receive Hyamax® Volumizer injection (n = 21) or no treatment (n = 7). Assessments included live and blinded evaluations by photographs on a chin retrusion scale (Galderma Chin Retrusion Scale), aesthetic improvement (Global Aesthetic Improvement Scale) by the subjects and independent evaluators, and safety follow-up at 3, 6, 9, and 12 months.</p><p><strong>Results: </strong>Hyamax® Volumizer was superior in improving chin retrusion at 6 months with a GCRS response rate of 57.14% versus 0% of the controls (P<0.0001) meeting the primary effectiveness objective. The GCRS and GAIS scores by subjects and evaluators achieved remarkable improvement at all follow-up points compared with the control group through 12 months. Common ISRs were injection-site pain (90.48%), tenderness (80.95%), redness (47.62%) and ecchymosis (19.05%). No serious treatment-related advert events were reported.</p><p><strong>Conclusion: </strong>Hyamax® Volumizer significantly restored the facial volume and improved the chin projection with safety.</p><p><strong>Level of evidence i: </strong>This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .</p>\",\"PeriodicalId\":7609,\"journal\":{\"name\":\"Aesthetic Plastic Surgery\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":2.0000,\"publicationDate\":\"2024-11-13\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Aesthetic Plastic Surgery\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s00266-024-04489-x\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"SURGERY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Aesthetic Plastic Surgery","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s00266-024-04489-x","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"SURGERY","Score":null,"Total":0}
Hyamax® Monophasic Volumizer Dermal Fillers for Chin Restoration: A Prospective, Single-Center, Investigator-Blinded, Randomized Controlled Trial.
Background: Hyamax® Monophasic Volumizer Dermal Fillers is a newly designed hyaluronic acid soft tissue filler for chin augmentation.
Methods: A prospective, single-center, evaluator-blinded, randomized controlled study was designed to evaluate the effectiveness and safety of Hyamax® Volumizer in the correction of chin retrusion in the 18-55-year-old Chinese population for 12 months after treatment. Participants were randomized (3:1) to receive Hyamax® Volumizer injection (n = 21) or no treatment (n = 7). Assessments included live and blinded evaluations by photographs on a chin retrusion scale (Galderma Chin Retrusion Scale), aesthetic improvement (Global Aesthetic Improvement Scale) by the subjects and independent evaluators, and safety follow-up at 3, 6, 9, and 12 months.
Results: Hyamax® Volumizer was superior in improving chin retrusion at 6 months with a GCRS response rate of 57.14% versus 0% of the controls (P<0.0001) meeting the primary effectiveness objective. The GCRS and GAIS scores by subjects and evaluators achieved remarkable improvement at all follow-up points compared with the control group through 12 months. Common ISRs were injection-site pain (90.48%), tenderness (80.95%), redness (47.62%) and ecchymosis (19.05%). No serious treatment-related advert events were reported.
Conclusion: Hyamax® Volumizer significantly restored the facial volume and improved the chin projection with safety.
Level of evidence i: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .
期刊介绍:
Aesthetic Plastic Surgery is a publication of the International Society of Aesthetic Plastic Surgery and the official journal of the European Association of Societies of Aesthetic Plastic Surgery (EASAPS), Società Italiana di Chirurgia Plastica Ricostruttiva ed Estetica (SICPRE), Vereinigung der Deutschen Aesthetisch Plastischen Chirurgen (VDAPC), the Romanian Aesthetic Surgery Society (RASS), Asociación Española de Cirugía Estética Plástica (AECEP), La Sociedad Argentina de Cirugía Plástica, Estética y Reparadora (SACPER), the Rhinoplasty Society of Europe (RSE), the Iranian Society of Plastic and Aesthetic Surgeons (ISPAS), the Singapore Association of Plastic Surgeons (SAPS), the Australasian Society of Aesthetic Plastic Surgeons (ASAPS), the Egyptian Society of Plastic and Reconstructive Surgeons (ESPRS), and the Sociedad Chilena de Cirugía Plástica, Reconstructiva y Estética (SCCP).
Aesthetic Plastic Surgery provides a forum for original articles advancing the art of aesthetic plastic surgery. Many describe surgical craftsmanship; others deal with complications in surgical procedures and methods by which to treat or avoid them. Coverage includes "second thoughts" on established techniques, which might be abandoned, modified, or improved. Also included are case histories; improvements in surgical instruments, pharmaceuticals, and operating room equipment; and discussions of problems such as the role of psychosocial factors in the doctor-patient and the patient-public interrelationships.
Aesthetic Plastic Surgery is covered in Current Contents/Clinical Medicine, SciSearch, Research Alert, Index Medicus-Medline, and Excerpta Medica/Embase.