{"title":"一种推荐的透明质酸（Lunaphil Ultra）与参考产品（juv<e:1> Ultra 4）治疗中度或重度鼻唇褶皱的疗效和安全性：一项随机、双盲、受试者内、等效对照试验","authors":"Kamran Jazayeri, Omid Zargari, Hoshyar Gholami, Araz Sabzvari, Hamidreza Kafi, Kamran Balighi","doi":"10.1093/asj/sjaf156","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Nasolabial folds (NLFs) are a natural alteration that become more noticeable with aging and dramatically affect facial skin beauty. Hyaluronic acid (HA) dermal fillers are frequently utilized to correct these visible signs of aging.</p><p><strong>Objective: </strong>The objective of this study was to evaluate and compare the effectiveness and safety of Lunaphil Ultra vs Juvéderm Ultra 4 in the treatment of NLFs.</p><p><strong>Methods: </strong>Each participant received Lunaphil Ultra and Juvéderm Ultra 4 in 1 of their NLFs. For each participant the products were injected at the first visit, and if needed an additional injection (touch-up) was done at the second visit. The duration of the study was 24 weeks for each participant. The primary outcome of this study was to assess the mean level of NLF severity score improvement compared to baseline with the Wrinkle Severity Rating Scale (WSRS) at Week 24.</p><p><strong>Results: </strong>The mean ± SD level of improvement by WSRS was -0.80 ± 0.66 for Lunaphil Ultra and -0.81 ± 0.67 for the Juvéderm Ultra 4 group (P value > .99). The difference between the 2 groups was within the predefined equivalency margin of ± 0.17. Of the treated NLFs, 71.15% in the Lunaphil Ultra group and 66.35% in the Juvéderm Ultra 4 group received a touch-up injection (P value = .33).</p><p><strong>Conclusions: </strong>As indicated by the study results, Lunaphil Ultra had an acceptable efficacy and safety profile in the Iranian population and was equivalent to Juvéderm Ultra 4 in WSRS improvement.</p>","PeriodicalId":7728,"journal":{"name":"Aesthetic Surgery Journal","volume":" ","pages":""},"PeriodicalIF":3.0000,"publicationDate":"2025-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Efficacy and Safety of a Proposed Hyaluronic Acid (Lunaphil Ultra) Compared to the Reference Product (Juvéderm Ultra 4) for the Management of Moderate or Severe Nasolabial Folds: A Randomized, Double-Masked, Within-Subject, Equivalency-Controlled Trial.\",\"authors\":\"Kamran Jazayeri, Omid Zargari, Hoshyar Gholami, Araz Sabzvari, Hamidreza Kafi, Kamran Balighi\",\"doi\":\"10.1093/asj/sjaf156\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Nasolabial folds (NLFs) are a natural alteration that become more noticeable with aging and dramatically affect facial skin beauty. Hyaluronic acid (HA) dermal fillers are frequently utilized to correct these visible signs of aging.</p><p><strong>Objective: </strong>The objective of this study was to evaluate and compare the effectiveness and safety of Lunaphil Ultra vs Juvéderm Ultra 4 in the treatment of NLFs.</p><p><strong>Methods: </strong>Each participant received Lunaphil Ultra and Juvéderm Ultra 4 in 1 of their NLFs. For each participant the products were injected at the first visit, and if needed an additional injection (touch-up) was done at the second visit. The duration of the study was 24 weeks for each participant. The primary outcome of this study was to assess the mean level of NLF severity score improvement compared to baseline with the Wrinkle Severity Rating Scale (WSRS) at Week 24.</p><p><strong>Results: </strong>The mean ± SD level of improvement by WSRS was -0.80 ± 0.66 for Lunaphil Ultra and -0.81 ± 0.67 for the Juvéderm Ultra 4 group (P value > .99). The difference between the 2 groups was within the predefined equivalency margin of ± 0.17. Of the treated NLFs, 71.15% in the Lunaphil Ultra group and 66.35% in the Juvéderm Ultra 4 group received a touch-up injection (P value = .33).</p><p><strong>Conclusions: </strong>As indicated by the study results, Lunaphil Ultra had an acceptable efficacy and safety profile in the Iranian population and was equivalent to Juvéderm Ultra 4 in WSRS improvement.</p>\",\"PeriodicalId\":7728,\"journal\":{\"name\":\"Aesthetic Surgery Journal\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":3.0000,\"publicationDate\":\"2025-08-05\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Aesthetic Surgery Journal\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1093/asj/sjaf156\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"SURGERY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Aesthetic Surgery Journal","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1093/asj/sjaf156","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"SURGERY","Score":null,"Total":0}
Efficacy and Safety of a Proposed Hyaluronic Acid (Lunaphil Ultra) Compared to the Reference Product (Juvéderm Ultra 4) for the Management of Moderate or Severe Nasolabial Folds: A Randomized, Double-Masked, Within-Subject, Equivalency-Controlled Trial.
Background: Nasolabial folds (NLFs) are a natural alteration that become more noticeable with aging and dramatically affect facial skin beauty. Hyaluronic acid (HA) dermal fillers are frequently utilized to correct these visible signs of aging.
Objective: The objective of this study was to evaluate and compare the effectiveness and safety of Lunaphil Ultra vs Juvéderm Ultra 4 in the treatment of NLFs.
Methods: Each participant received Lunaphil Ultra and Juvéderm Ultra 4 in 1 of their NLFs. For each participant the products were injected at the first visit, and if needed an additional injection (touch-up) was done at the second visit. The duration of the study was 24 weeks for each participant. The primary outcome of this study was to assess the mean level of NLF severity score improvement compared to baseline with the Wrinkle Severity Rating Scale (WSRS) at Week 24.
Results: The mean ± SD level of improvement by WSRS was -0.80 ± 0.66 for Lunaphil Ultra and -0.81 ± 0.67 for the Juvéderm Ultra 4 group (P value > .99). The difference between the 2 groups was within the predefined equivalency margin of ± 0.17. Of the treated NLFs, 71.15% in the Lunaphil Ultra group and 66.35% in the Juvéderm Ultra 4 group received a touch-up injection (P value = .33).
Conclusions: As indicated by the study results, Lunaphil Ultra had an acceptable efficacy and safety profile in the Iranian population and was equivalent to Juvéderm Ultra 4 in WSRS improvement.
期刊介绍：
Aesthetic Surgery Journal is a peer-reviewed international journal focusing on scientific developments and clinical techniques in aesthetic surgery. The official publication of The Aesthetic Society, ASJ is also the official English-language journal of many major international societies of plastic, aesthetic and reconstructive surgery representing South America, Central America, Europe, Asia, and the Middle East. It is also the official journal of the British Association of Aesthetic Plastic Surgeons, the Canadian Society for Aesthetic Plastic Surgery and The Rhinoplasty Society.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
