William Coleman, Vince Bertucci, Shannon Humphrey, Joely Kaufman-Janette, Terrence Keaney, David Pariser, Nowell Solish, David Wirta, Robert A Weiss
{"title":"在两项三期临床试验中，NivobotulinumtoxinA 在治疗麦粒肿纹的同时治疗或不治疗眼轮匝肌外侧纹。","authors":"William Coleman, Vince Bertucci, Shannon Humphrey, Joely Kaufman-Janette, Terrence Keaney, David Pariser, Nowell Solish, David Wirta, Robert A Weiss","doi":"10.1093/asj/sjae233","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Botulinum neurotoxins in aesthetic medicine require reconstitution before administration, which may be inconvenient and present errors among injectors.</p><p><strong>Objectives: </strong>The aim of this study was to evaluate the efficacy and safety of ready-to-use nivobotulinumtoxinA liquid formulation for the treatment of glabellar lines (GL) with or without treatment of lateral canthal lines (LCL).</p><p><strong>Methods: </strong>Two multicenter, phase 3, double-blind, randomized trials enrolled participants with moderate-to-severe GL (Study 001) or moderate-to-severe GL + LCL (Study 005). Participants received double-blind nivobotulinumtoxinA (20 U) or placebo (Period 1) then ≤2 open-label nivobotulinumtoxinA GL treatments (Period 2) in Study 001 or double-blind nivobotulinumtoxinA 20 U (GL), nivobotulinumtoxinA 44 U (GL + LCL), or placebo (Period 1) then ≤2 double-blind injections of the same treatment (Period 2) in Study 005. The composite primary endpoint was the proportion of participants achieving a ≥2-grade improvement on a facial wrinkle scale at maximum frown on investigator and participant assessment; coprimary endpoints were investigator- and participant-assessed FWS \"none or mild\" ratings.</p><p><strong>Results: </strong>At Day 30, significantly higher responder rates were observed for the composite primary endpoint with GL treatment alone (Study 001, 46.1%; Study 005, 45.1%) and GL + LCL (Study 005, 41.3%) vs placebo (0%; all P < .001). Responder rates of \"none or mild\" by investigator and participant assessment, respectively, were significantly higher for GL treatment alone (Study 001, 77.2% and 65.0%; Study 005, 74.3% and 68.8%) and GL + LCL (Study 005, 74.0% and 61.2%) vs placebo (all P < .001). Adverse events were similar between treatment groups and placebo.</p><p><strong>Conclusions: </strong>Liquid nivobotulinumtoxinA was effective and well tolerated for treating moderate-to-severe GL alone or with LCL.</p><p><strong>Level of evidence: 1 (therapeutic): </strong></p>","PeriodicalId":7728,"journal":{"name":"Aesthetic Surgery Journal","volume":" ","pages":"404-413"},"PeriodicalIF":3.0000,"publicationDate":"2025-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11913111/pdf/","citationCount":"0","resultStr":"{\"title\":\"NivobotulinumtoxinA in the Treatment of Glabellar Lines With or Without Concurrent Treatment of Lateral Canthal Lines in Two Phase 3 Clinical Trials.\",\"authors\":\"William Coleman, Vince Bertucci, Shannon Humphrey, Joely Kaufman-Janette, Terrence Keaney, David Pariser, Nowell Solish, David Wirta, Robert A Weiss\",\"doi\":\"10.1093/asj/sjae233\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Botulinum neurotoxins in aesthetic medicine require reconstitution before administration, which may be inconvenient and present errors among injectors.</p><p><strong>Objectives: </strong>The aim of this study was to evaluate the efficacy and safety of ready-to-use nivobotulinumtoxinA liquid formulation for the treatment of glabellar lines (GL) with or without treatment of lateral canthal lines (LCL).</p><p><strong>Methods: </strong>Two multicenter, phase 3, double-blind, randomized trials enrolled participants with moderate-to-severe GL (Study 001) or moderate-to-severe GL + LCL (Study 005). Participants received double-blind nivobotulinumtoxinA (20 U) or placebo (Period 1) then ≤2 open-label nivobotulinumtoxinA GL treatments (Period 2) in Study 001 or double-blind nivobotulinumtoxinA 20 U (GL), nivobotulinumtoxinA 44 U (GL + LCL), or placebo (Period 1) then ≤2 double-blind injections of the same treatment (Period 2) in Study 005. The composite primary endpoint was the proportion of participants achieving a ≥2-grade improvement on a facial wrinkle scale at maximum frown on investigator and participant assessment; coprimary endpoints were investigator- and participant-assessed FWS \\\"none or mild\\\" ratings.</p><p><strong>Results: </strong>At Day 30, significantly higher responder rates were observed for the composite primary endpoint with GL treatment alone (Study 001, 46.1%; Study 005, 45.1%) and GL + LCL (Study 005, 41.3%) vs placebo (0%; all P < .001). Responder rates of \\\"none or mild\\\" by investigator and participant assessment, respectively, were significantly higher for GL treatment alone (Study 001, 77.2% and 65.0%; Study 005, 74.3% and 68.8%) and GL + LCL (Study 005, 74.0% and 61.2%) vs placebo (all P < .001). 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NivobotulinumtoxinA in the Treatment of Glabellar Lines With or Without Concurrent Treatment of Lateral Canthal Lines in Two Phase 3 Clinical Trials.
Background: Botulinum neurotoxins in aesthetic medicine require reconstitution before administration, which may be inconvenient and present errors among injectors.
Objectives: The aim of this study was to evaluate the efficacy and safety of ready-to-use nivobotulinumtoxinA liquid formulation for the treatment of glabellar lines (GL) with or without treatment of lateral canthal lines (LCL).
Methods: Two multicenter, phase 3, double-blind, randomized trials enrolled participants with moderate-to-severe GL (Study 001) or moderate-to-severe GL + LCL (Study 005). Participants received double-blind nivobotulinumtoxinA (20 U) or placebo (Period 1) then ≤2 open-label nivobotulinumtoxinA GL treatments (Period 2) in Study 001 or double-blind nivobotulinumtoxinA 20 U (GL), nivobotulinumtoxinA 44 U (GL + LCL), or placebo (Period 1) then ≤2 double-blind injections of the same treatment (Period 2) in Study 005. The composite primary endpoint was the proportion of participants achieving a ≥2-grade improvement on a facial wrinkle scale at maximum frown on investigator and participant assessment; coprimary endpoints were investigator- and participant-assessed FWS "none or mild" ratings.
Results: At Day 30, significantly higher responder rates were observed for the composite primary endpoint with GL treatment alone (Study 001, 46.1%; Study 005, 45.1%) and GL + LCL (Study 005, 41.3%) vs placebo (0%; all P < .001). Responder rates of "none or mild" by investigator and participant assessment, respectively, were significantly higher for GL treatment alone (Study 001, 77.2% and 65.0%; Study 005, 74.3% and 68.8%) and GL + LCL (Study 005, 74.0% and 61.2%) vs placebo (all P < .001). Adverse events were similar between treatment groups and placebo.
Conclusions: Liquid nivobotulinumtoxinA was effective and well tolerated for treating moderate-to-severe GL alone or with LCL.
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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