Liquid AbobotulinumtoxinA: Pooled Data From Two Double-Blind, Randomized, Placebo-Controlled Phase III Studies of Glabellar Line Treatment
AbobotulinumtoxinA (aboBoNT-A) solution is a new ready-to-use formulation developed to reduce preparation time and improve reproducibility of injections. To further evaluate treatment of moderate-to-severe glabellar lines (GLs) using pooled data from 2 Phase III studies. Following double-blind treat...
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Veröffentlicht in: | Dermatologic surgery 2022-11, Vol.48 (11), p.1198-1202 |
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creator | Hilton, Said Kestemont, Philippe Sattler, Gerhard Volteau, Magali Thompson, Catherine Andriopoulos, Bill Prygova, Inna Berg, Anna-Karin Ascher, Benjamin |
description | AbobotulinumtoxinA (aboBoNT-A) solution is a new ready-to-use formulation developed to reduce preparation time and improve reproducibility of injections.
To further evaluate treatment of moderate-to-severe glabellar lines (GLs) using pooled data from 2 Phase III studies.
Following double-blind treatment with 50 U aboBoNT-A solution (n = 251) or placebo (n = 123), GL severity was assessed by investigators (ILA) and subjects (SSA). Other assessments included subject-reported time to onset, subject satisfaction, FACE-Q, and adverse events.
One month after aboBoNT-A solution treatment, 88% had none-or-mild GLs at maximum frown and 93% had ≥1-grade improvement in ILA (similar for SSA), 24% to 27% remaining improved at Month 6. Glabellar lines responder rates remained higher than placebo throughout Month 6 ( p < .001). Almost two-thirds of subjects reported onset within 3 days, nearly a quarter reporting effect by Day 1. Subject satisfaction with GL appearance, and FACE-Q satisfaction with facial appearance overall and psychological well-being were also improved over placebo throughout Month 6, p < .05. Treatment-related adverse events were nonserious and mild or moderate.
Pooled analysis confirmed a duration of effect on GLs of up to 6 months for aboBoNT-A solution, with onset starting within 24 hours, high subject satisfaction, and improved psychological well-being. The treatment was well tolerated. |
doi_str_mv | 10.1097/DSS.0000000000003594 |
format | Article |
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To further evaluate treatment of moderate-to-severe glabellar lines (GLs) using pooled data from 2 Phase III studies.
Following double-blind treatment with 50 U aboBoNT-A solution (n = 251) or placebo (n = 123), GL severity was assessed by investigators (ILA) and subjects (SSA). Other assessments included subject-reported time to onset, subject satisfaction, FACE-Q, and adverse events.
One month after aboBoNT-A solution treatment, 88% had none-or-mild GLs at maximum frown and 93% had ≥1-grade improvement in ILA (similar for SSA), 24% to 27% remaining improved at Month 6. Glabellar lines responder rates remained higher than placebo throughout Month 6 ( p < .001). Almost two-thirds of subjects reported onset within 3 days, nearly a quarter reporting effect by Day 1. Subject satisfaction with GL appearance, and FACE-Q satisfaction with facial appearance overall and psychological well-being were also improved over placebo throughout Month 6, p < .05. Treatment-related adverse events were nonserious and mild or moderate.
Pooled analysis confirmed a duration of effect on GLs of up to 6 months for aboBoNT-A solution, with onset starting within 24 hours, high subject satisfaction, and improved psychological well-being. The treatment was well tolerated.</description><identifier>ISSN: 1076-0512</identifier><identifier>ISSN: 1524-4725</identifier><identifier>EISSN: 1524-4725</identifier><identifier>DOI: 10.1097/DSS.0000000000003594</identifier><identifier>PMID: 36206385</identifier><language>eng</language><publisher>United States: Lippincott Williams & Wilkins</publisher><subject>Botulinum Toxins, Type A ; Clinical Trials, Phase III as Topic ; Double-Blind Method ; Forehead ; Humans ; Neuromuscular Agents ; Randomized Controlled Trials as Topic ; Reproducibility of Results ; Skin Aging ; Treatment Outcome</subject><ispartof>Dermatologic surgery, 2022-11, Vol.48 (11), p.1198-1202</ispartof><rights>Lippincott Williams & Wilkins</rights><rights>Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Society for Dermatologic Surgery, Inc.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3983-b76372bd183cafa6e606cb6a86322d3da375a7f77bddba0c5e6818ea9e9ebae33</citedby><cites>FETCH-LOGICAL-c3983-b76372bd183cafa6e606cb6a86322d3da375a7f77bddba0c5e6818ea9e9ebae33</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27923,27924</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/36206385$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Hilton, Said</creatorcontrib><creatorcontrib>Kestemont, Philippe</creatorcontrib><creatorcontrib>Sattler, Gerhard</creatorcontrib><creatorcontrib>Volteau, Magali</creatorcontrib><creatorcontrib>Thompson, Catherine</creatorcontrib><creatorcontrib>Andriopoulos, Bill</creatorcontrib><creatorcontrib>Prygova, Inna</creatorcontrib><creatorcontrib>Berg, Anna-Karin</creatorcontrib><creatorcontrib>Ascher, Benjamin</creatorcontrib><title>Liquid AbobotulinumtoxinA: Pooled Data From Two Double-Blind, Randomized, Placebo-Controlled Phase III Studies of Glabellar Line Treatment</title><title>Dermatologic surgery</title><addtitle>Dermatol Surg</addtitle><description>AbobotulinumtoxinA (aboBoNT-A) solution is a new ready-to-use formulation developed to reduce preparation time and improve reproducibility of injections.
To further evaluate treatment of moderate-to-severe glabellar lines (GLs) using pooled data from 2 Phase III studies.
Following double-blind treatment with 50 U aboBoNT-A solution (n = 251) or placebo (n = 123), GL severity was assessed by investigators (ILA) and subjects (SSA). Other assessments included subject-reported time to onset, subject satisfaction, FACE-Q, and adverse events.
One month after aboBoNT-A solution treatment, 88% had none-or-mild GLs at maximum frown and 93% had ≥1-grade improvement in ILA (similar for SSA), 24% to 27% remaining improved at Month 6. Glabellar lines responder rates remained higher than placebo throughout Month 6 ( p < .001). Almost two-thirds of subjects reported onset within 3 days, nearly a quarter reporting effect by Day 1. Subject satisfaction with GL appearance, and FACE-Q satisfaction with facial appearance overall and psychological well-being were also improved over placebo throughout Month 6, p < .05. Treatment-related adverse events were nonserious and mild or moderate.
Pooled analysis confirmed a duration of effect on GLs of up to 6 months for aboBoNT-A solution, with onset starting within 24 hours, high subject satisfaction, and improved psychological well-being. The treatment was well tolerated.</description><subject>Botulinum Toxins, Type A</subject><subject>Clinical Trials, Phase III as Topic</subject><subject>Double-Blind Method</subject><subject>Forehead</subject><subject>Humans</subject><subject>Neuromuscular Agents</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Reproducibility of Results</subject><subject>Skin Aging</subject><subject>Treatment Outcome</subject><issn>1076-0512</issn><issn>1524-4725</issn><issn>1524-4725</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpdUduO0zAQtRCIXRb-ACE_8kAWXxI74a3bskulSlS0PEfjeKIGnHjXdlTgE_hqXO1yESONZkY658xoDiEvObvkrNFvV7vdJfsnZNWUj8g5r0RZlFpUj3PPtCpYxcUZeRbjF8a4aCR7Ss6kEkzJujonPzfD3TxYujDe-DS7YZrH5L8N0-Id3Xrv0NIVJKDXwY90f_R05WfjsLjKSPuGfoLJ-nH4gbnfOujQ-GLppxS8O1G3B4hI1-s13aXZDhip7-mNA4POQaCbYUK6DwhpxCk9J096cBFfPNQL8vn6_X75odh8vFkvF5uik00tC6OV1MJYXssOelComOqMglpJIay0IHUFutfaWGuAdRWqmtcIDTZoAKW8IK_vdW-Dv5sxpnYcYne6aEI_x1ZoIXlV1YJlaHkP7YKPMWDf3oZhhPC95aw9udBmF9r_Xci0Vw8bZjOi_UP6_fa_ukfvEob41c1HDO0BwaXDSa_MR9SFYEJwnsciJ5fyF2H4k0o</recordid><startdate>20221101</startdate><enddate>20221101</enddate><creator>Hilton, Said</creator><creator>Kestemont, Philippe</creator><creator>Sattler, Gerhard</creator><creator>Volteau, Magali</creator><creator>Thompson, Catherine</creator><creator>Andriopoulos, Bill</creator><creator>Prygova, Inna</creator><creator>Berg, Anna-Karin</creator><creator>Ascher, Benjamin</creator><general>Lippincott Williams & Wilkins</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20221101</creationdate><title>Liquid AbobotulinumtoxinA: Pooled Data From Two Double-Blind, Randomized, Placebo-Controlled Phase III Studies of Glabellar Line Treatment</title><author>Hilton, Said ; Kestemont, Philippe ; Sattler, Gerhard ; Volteau, Magali ; Thompson, Catherine ; Andriopoulos, Bill ; Prygova, Inna ; Berg, Anna-Karin ; Ascher, Benjamin</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3983-b76372bd183cafa6e606cb6a86322d3da375a7f77bddba0c5e6818ea9e9ebae33</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Botulinum Toxins, Type A</topic><topic>Clinical Trials, Phase III as Topic</topic><topic>Double-Blind Method</topic><topic>Forehead</topic><topic>Humans</topic><topic>Neuromuscular Agents</topic><topic>Randomized Controlled Trials as Topic</topic><topic>Reproducibility of Results</topic><topic>Skin Aging</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Hilton, Said</creatorcontrib><creatorcontrib>Kestemont, Philippe</creatorcontrib><creatorcontrib>Sattler, Gerhard</creatorcontrib><creatorcontrib>Volteau, Magali</creatorcontrib><creatorcontrib>Thompson, Catherine</creatorcontrib><creatorcontrib>Andriopoulos, Bill</creatorcontrib><creatorcontrib>Prygova, Inna</creatorcontrib><creatorcontrib>Berg, Anna-Karin</creatorcontrib><creatorcontrib>Ascher, Benjamin</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Dermatologic surgery</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Hilton, Said</au><au>Kestemont, Philippe</au><au>Sattler, Gerhard</au><au>Volteau, Magali</au><au>Thompson, Catherine</au><au>Andriopoulos, Bill</au><au>Prygova, Inna</au><au>Berg, Anna-Karin</au><au>Ascher, Benjamin</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Liquid AbobotulinumtoxinA: Pooled Data From Two Double-Blind, Randomized, Placebo-Controlled Phase III Studies of Glabellar Line Treatment</atitle><jtitle>Dermatologic surgery</jtitle><addtitle>Dermatol Surg</addtitle><date>2022-11-01</date><risdate>2022</risdate><volume>48</volume><issue>11</issue><spage>1198</spage><epage>1202</epage><pages>1198-1202</pages><issn>1076-0512</issn><issn>1524-4725</issn><eissn>1524-4725</eissn><abstract>AbobotulinumtoxinA (aboBoNT-A) solution is a new ready-to-use formulation developed to reduce preparation time and improve reproducibility of injections.
To further evaluate treatment of moderate-to-severe glabellar lines (GLs) using pooled data from 2 Phase III studies.
Following double-blind treatment with 50 U aboBoNT-A solution (n = 251) or placebo (n = 123), GL severity was assessed by investigators (ILA) and subjects (SSA). Other assessments included subject-reported time to onset, subject satisfaction, FACE-Q, and adverse events.
One month after aboBoNT-A solution treatment, 88% had none-or-mild GLs at maximum frown and 93% had ≥1-grade improvement in ILA (similar for SSA), 24% to 27% remaining improved at Month 6. Glabellar lines responder rates remained higher than placebo throughout Month 6 ( p < .001). Almost two-thirds of subjects reported onset within 3 days, nearly a quarter reporting effect by Day 1. Subject satisfaction with GL appearance, and FACE-Q satisfaction with facial appearance overall and psychological well-being were also improved over placebo throughout Month 6, p < .05. Treatment-related adverse events were nonserious and mild or moderate.
Pooled analysis confirmed a duration of effect on GLs of up to 6 months for aboBoNT-A solution, with onset starting within 24 hours, high subject satisfaction, and improved psychological well-being. The treatment was well tolerated.</abstract><cop>United States</cop><pub>Lippincott Williams & Wilkins</pub><pmid>36206385</pmid><doi>10.1097/DSS.0000000000003594</doi><tpages>5</tpages><oa>free_for_read</oa></addata></record> |
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subjects | Botulinum Toxins, Type A Clinical Trials, Phase III as Topic Double-Blind Method Forehead Humans Neuromuscular Agents Randomized Controlled Trials as Topic Reproducibility of Results Skin Aging Treatment Outcome |
title | Liquid AbobotulinumtoxinA: Pooled Data From Two Double-Blind, Randomized, Placebo-Controlled Phase III Studies of Glabellar Line Treatment |
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