Sabrina G Fabi, Jennifer Htd Le, Inna Prygova, Daniel Bråsäter
{"title":"使用生物刺激性聚乳酸注射植入物进行面中部投影：面颊皱纹试验的分组分析。","authors":"Sabrina G Fabi, Jennifer Htd Le, Inna Prygova, Daniel Bråsäter","doi":"10.1097/DSS.0000000000004434","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Correction of cheek wrinkles using poly-l-lactic acid (PLLA-SCA) was demonstrated in a 12-month study.</p><p><strong>Objective: </strong>This analysis assessed change from baseline in lifting effect of PLLA-SCA using a 3D camera to provide additional quantified data.</p><p><strong>Methods: </strong>Subjects received PLLA-SCA (reconstituted in 8 mL of sterile water + 1 mL of 2% lidocaine) in both cheeks or no treatment (control). Assessments included the Galderma Cheek Wrinkle Scale (GCWS), aesthetic improvement, and 3D photography. In subjects with severe GCWS at baseline, Canfield software analyzed 3D images for change from baseline in midface volume projection and volume change of both cheeks at Month 9.</p><p><strong>Results: </strong>The primary study showed a statistically significant higher at-rest GCWS responder rate at Month 12 for PLLA-SCA, 71.6%, versus control, 26.1% (p < .0001). In this Month 9 analysis, mean midface volume projection demonstrated a positive volume shift for PLLA-SCA (left: 0.45 mm; right: 0.34 mm; n = 46) versus control (left: 0.25 mm; right: -0.01 mm; n = 21). Midface volume and max projection changes for PLLA-SCA were +4.88 mL/+1.62 mm (left), +2.84 mL/+1.12 mm (right) versus +0.26 mL/+0.34 mm (left), +0.68 mL/+0.37 mm (right) for control.</p><p><strong>Conclusion: </strong>Poly-l-lactic acid-treatment of subjects with severe GCWS had a clinically meaningful lifting effect in both cheeks (positive volume shift, positive volume change, and max projection) in the midface.</p><p><strong>Clinical trial registry number: </strong>NCT04124692.</p>","PeriodicalId":11289,"journal":{"name":"Dermatologic Surgery","volume":" ","pages":""},"PeriodicalIF":2.5000,"publicationDate":"2024-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Midface Projection Using Biostimulatory Poly-l-Lactic Acid Injectable Implant: A Subgroup Analysis of the Cheek Wrinkle Trial.\",\"authors\":\"Sabrina G Fabi, Jennifer Htd Le, Inna Prygova, Daniel Bråsäter\",\"doi\":\"10.1097/DSS.0000000000004434\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Correction of cheek wrinkles using poly-l-lactic acid (PLLA-SCA) was demonstrated in a 12-month study.</p><p><strong>Objective: </strong>This analysis assessed change from baseline in lifting effect of PLLA-SCA using a 3D camera to provide additional quantified data.</p><p><strong>Methods: </strong>Subjects received PLLA-SCA (reconstituted in 8 mL of sterile water + 1 mL of 2% lidocaine) in both cheeks or no treatment (control). Assessments included the Galderma Cheek Wrinkle Scale (GCWS), aesthetic improvement, and 3D photography. In subjects with severe GCWS at baseline, Canfield software analyzed 3D images for change from baseline in midface volume projection and volume change of both cheeks at Month 9.</p><p><strong>Results: </strong>The primary study showed a statistically significant higher at-rest GCWS responder rate at Month 12 for PLLA-SCA, 71.6%, versus control, 26.1% (p < .0001). In this Month 9 analysis, mean midface volume projection demonstrated a positive volume shift for PLLA-SCA (left: 0.45 mm; right: 0.34 mm; n = 46) versus control (left: 0.25 mm; right: -0.01 mm; n = 21). Midface volume and max projection changes for PLLA-SCA were +4.88 mL/+1.62 mm (left), +2.84 mL/+1.12 mm (right) versus +0.26 mL/+0.34 mm (left), +0.68 mL/+0.37 mm (right) for control.</p><p><strong>Conclusion: </strong>Poly-l-lactic acid-treatment of subjects with severe GCWS had a clinically meaningful lifting effect in both cheeks (positive volume shift, positive volume change, and max projection) in the midface.</p><p><strong>Clinical trial registry number: </strong>NCT04124692.</p>\",\"PeriodicalId\":11289,\"journal\":{\"name\":\"Dermatologic Surgery\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":2.5000,\"publicationDate\":\"2024-10-17\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Dermatologic Surgery\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1097/DSS.0000000000004434\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"DERMATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Dermatologic Surgery","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1097/DSS.0000000000004434","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"DERMATOLOGY","Score":null,"Total":0}
Midface Projection Using Biostimulatory Poly-l-Lactic Acid Injectable Implant: A Subgroup Analysis of the Cheek Wrinkle Trial.
Background: Correction of cheek wrinkles using poly-l-lactic acid (PLLA-SCA) was demonstrated in a 12-month study.
Objective: This analysis assessed change from baseline in lifting effect of PLLA-SCA using a 3D camera to provide additional quantified data.
Methods: Subjects received PLLA-SCA (reconstituted in 8 mL of sterile water + 1 mL of 2% lidocaine) in both cheeks or no treatment (control). Assessments included the Galderma Cheek Wrinkle Scale (GCWS), aesthetic improvement, and 3D photography. In subjects with severe GCWS at baseline, Canfield software analyzed 3D images for change from baseline in midface volume projection and volume change of both cheeks at Month 9.
Results: The primary study showed a statistically significant higher at-rest GCWS responder rate at Month 12 for PLLA-SCA, 71.6%, versus control, 26.1% (p < .0001). In this Month 9 analysis, mean midface volume projection demonstrated a positive volume shift for PLLA-SCA (left: 0.45 mm; right: 0.34 mm; n = 46) versus control (left: 0.25 mm; right: -0.01 mm; n = 21). Midface volume and max projection changes for PLLA-SCA were +4.88 mL/+1.62 mm (left), +2.84 mL/+1.12 mm (right) versus +0.26 mL/+0.34 mm (left), +0.68 mL/+0.37 mm (right) for control.
Conclusion: Poly-l-lactic acid-treatment of subjects with severe GCWS had a clinically meaningful lifting effect in both cheeks (positive volume shift, positive volume change, and max projection) in the midface.
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.
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