Michael H Gold, Lisa Donofrio, Sachin Shridharani, Amir Moradi, Brian Biesman, Melissa Chiang, Rosalyn George, Kristel Polder, Nowell Solish, Rob Schwarcz, Anna-Karin Berg, Felipe Weinberg, Eva Axén
{"title":"Relabotulinumtoxina即食液体制剂改善glabella线和满意度的受试者报告结果：来自3期READY-1试验的数据。","authors":"Michael H Gold, Lisa Donofrio, Sachin Shridharani, Amir Moradi, Brian Biesman, Melissa Chiang, Rosalyn George, Kristel Polder, Nowell Solish, Rob Schwarcz, Anna-Karin Berg, Felipe Weinberg, Eva Axén","doi":"10.1093/asj/sjaf063","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>RelabotulinumtoxinA (relaBoNT-A; Relfydess, Galderma, Uppsala, Sweden) is a novel, ready-to-use liquid form of botulinum toxin A, created using PEARL technology to produce a highly effective, complex-free formulation.</p><p><strong>Objectives: </strong>Reporting of subject-assessed effectiveness and satisfaction outcomes from the relaBoNT-A phase 3 READY-1 study.</p><p><strong>Methods: </strong>Adults with moderate-to-severe glabellar lines were randomized 3:1 to receive relaBoNT-A (50 U) or placebo in a 6-month, double-blind, multicenter study. Subject-reported endpoints at maximum frown included ≥1 grade improvement on the glabellar line subject live assessment (GL-SLA) scale from baseline and Global Aesthetic Improvement Scale (GAIS) score. Satisfaction and well-being investigations used the Facial Lines Treatment Satisfaction Questionnaire (FLTSQ), Natural Expressions Questionnaire and FACE-Q Psychological Function Questionnaire.</p><p><strong>Results: </strong>Overall, 233 adults received relaBoNT-A and 74 received placebo. RelaBoNT-A responder rates for ≥1-grade GL-SLA improvement from baseline at Day 7 and Months 1, 3 and 6 were 97.2, 97.7, 90.0 and 71.0%, respectively, versus 18.9, 26.8, 27.5 and 22.4% with placebo (P<0.001). GAIS responder rates were 74.3-98.1% (relaBoNT-A) and 9.0-16.2% (placebo). Post-treatment FLTSQ Rasch-transformed scores were higher with relaBoNT-A (≥62.5) than placebo (≤49.8) for the Appearance Module and Treatment Satisfaction Module (relaBoNT-A: ≥83.0; placebo: ≤36.8). RelaBoNT-A-treated subjects reported looking natural (≥83.3%) and feeling confident when making facial expressions (≥75.7%). Mean change in FACE-Q well-being score was higher with relaBoNT-A (11.0-13.7) versus placebo (0.6-4.5).</p><p><strong>Conclusions: </strong>Adults with moderate-to-severe glabellar lines receiving a single relaBoNT-A treatment reported significant improvements in glabellar line severity throughout the 6-month study period. RelaBoNT-A provided natural looking results, high satisfaction and psychological well-being improvements.</p>","PeriodicalId":7728,"journal":{"name":"Aesthetic Surgery Journal","volume":" ","pages":""},"PeriodicalIF":3.0000,"publicationDate":"2025-04-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Subject-Reported Outcomes for Glabellar Line Improvement and Satisfaction With the Relabotulinumtoxina Ready-to-Use Liquid Formulation: Data From the Phase 3 READY-1 Trial.\",\"authors\":\"Michael H Gold, Lisa Donofrio, Sachin Shridharani, Amir Moradi, Brian Biesman, Melissa Chiang, Rosalyn George, Kristel Polder, Nowell Solish, Rob Schwarcz, Anna-Karin Berg, Felipe Weinberg, Eva Axén\",\"doi\":\"10.1093/asj/sjaf063\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>RelabotulinumtoxinA (relaBoNT-A; Relfydess, Galderma, Uppsala, Sweden) is a novel, ready-to-use liquid form of botulinum toxin A, created using PEARL technology to produce a highly effective, complex-free formulation.</p><p><strong>Objectives: </strong>Reporting of subject-assessed effectiveness and satisfaction outcomes from the relaBoNT-A phase 3 READY-1 study.</p><p><strong>Methods: </strong>Adults with moderate-to-severe glabellar lines were randomized 3:1 to receive relaBoNT-A (50 U) or placebo in a 6-month, double-blind, multicenter study. Subject-reported endpoints at maximum frown included ≥1 grade improvement on the glabellar line subject live assessment (GL-SLA) scale from baseline and Global Aesthetic Improvement Scale (GAIS) score. Satisfaction and well-being investigations used the Facial Lines Treatment Satisfaction Questionnaire (FLTSQ), Natural Expressions Questionnaire and FACE-Q Psychological Function Questionnaire.</p><p><strong>Results: </strong>Overall, 233 adults received relaBoNT-A and 74 received placebo. RelaBoNT-A responder rates for ≥1-grade GL-SLA improvement from baseline at Day 7 and Months 1, 3 and 6 were 97.2, 97.7, 90.0 and 71.0%, respectively, versus 18.9, 26.8, 27.5 and 22.4% with placebo (P<0.001). GAIS responder rates were 74.3-98.1% (relaBoNT-A) and 9.0-16.2% (placebo). Post-treatment FLTSQ Rasch-transformed scores were higher with relaBoNT-A (≥62.5) than placebo (≤49.8) for the Appearance Module and Treatment Satisfaction Module (relaBoNT-A: ≥83.0; placebo: ≤36.8). RelaBoNT-A-treated subjects reported looking natural (≥83.3%) and feeling confident when making facial expressions (≥75.7%). Mean change in FACE-Q well-being score was higher with relaBoNT-A (11.0-13.7) versus placebo (0.6-4.5).</p><p><strong>Conclusions: </strong>Adults with moderate-to-severe glabellar lines receiving a single relaBoNT-A treatment reported significant improvements in glabellar line severity throughout the 6-month study period. RelaBoNT-A provided natural looking results, high satisfaction and psychological well-being improvements.</p>\",\"PeriodicalId\":7728,\"journal\":{\"name\":\"Aesthetic Surgery Journal\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":3.0000,\"publicationDate\":\"2025-04-17\",\"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/sjaf063\",\"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/sjaf063","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"SURGERY","Score":null,"Total":0}
Subject-Reported Outcomes for Glabellar Line Improvement and Satisfaction With the Relabotulinumtoxina Ready-to-Use Liquid Formulation: Data From the Phase 3 READY-1 Trial.
Background: RelabotulinumtoxinA (relaBoNT-A; Relfydess, Galderma, Uppsala, Sweden) is a novel, ready-to-use liquid form of botulinum toxin A, created using PEARL technology to produce a highly effective, complex-free formulation.
Objectives: Reporting of subject-assessed effectiveness and satisfaction outcomes from the relaBoNT-A phase 3 READY-1 study.
Methods: Adults with moderate-to-severe glabellar lines were randomized 3:1 to receive relaBoNT-A (50 U) or placebo in a 6-month, double-blind, multicenter study. Subject-reported endpoints at maximum frown included ≥1 grade improvement on the glabellar line subject live assessment (GL-SLA) scale from baseline and Global Aesthetic Improvement Scale (GAIS) score. Satisfaction and well-being investigations used the Facial Lines Treatment Satisfaction Questionnaire (FLTSQ), Natural Expressions Questionnaire and FACE-Q Psychological Function Questionnaire.
Results: Overall, 233 adults received relaBoNT-A and 74 received placebo. RelaBoNT-A responder rates for ≥1-grade GL-SLA improvement from baseline at Day 7 and Months 1, 3 and 6 were 97.2, 97.7, 90.0 and 71.0%, respectively, versus 18.9, 26.8, 27.5 and 22.4% with placebo (P<0.001). GAIS responder rates were 74.3-98.1% (relaBoNT-A) and 9.0-16.2% (placebo). Post-treatment FLTSQ Rasch-transformed scores were higher with relaBoNT-A (≥62.5) than placebo (≤49.8) for the Appearance Module and Treatment Satisfaction Module (relaBoNT-A: ≥83.0; placebo: ≤36.8). RelaBoNT-A-treated subjects reported looking natural (≥83.3%) and feeling confident when making facial expressions (≥75.7%). Mean change in FACE-Q well-being score was higher with relaBoNT-A (11.0-13.7) versus placebo (0.6-4.5).
Conclusions: Adults with moderate-to-severe glabellar lines receiving a single relaBoNT-A treatment reported significant improvements in glabellar line severity throughout the 6-month study period. RelaBoNT-A provided natural looking results, high satisfaction and psychological well-being improvements.
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.
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