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Subject satisfaction and psychological well‐being with escalating abobotulinumtoxinA injection dose for the treatment of moderate to severe glabellar lines
BACKGROUND: Previous studies indicate that the efficacy and durability of a single AbobotulinumtoxinA (ABO) treatment for moderate to severe glabellar lines may be enhanced with increasing dose, while safety outcomes remain consistent with those of the licensed dose (50 U). AIMS: Evaluation of subje...
Autores principales: | , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9322427/ https://www.ncbi.nlm.nih.gov/pubmed/35266281 http://dx.doi.org/10.1111/jocd.14906 |
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author | Dayan, Steven Joseph, John Moradi, Amir Lorenc, Z. Paul Coleman, Kyle Ablon, Glynis Kaufman‐Janette, Joely Cox, Sue Ellen Campbell, Andrew Munavalli, Girish Prygova, Inna |
author_facet | Dayan, Steven Joseph, John Moradi, Amir Lorenc, Z. Paul Coleman, Kyle Ablon, Glynis Kaufman‐Janette, Joely Cox, Sue Ellen Campbell, Andrew Munavalli, Girish Prygova, Inna |
author_sort | Dayan, Steven |
collection | PubMed |
description | BACKGROUND: Previous studies indicate that the efficacy and durability of a single AbobotulinumtoxinA (ABO) treatment for moderate to severe glabellar lines may be enhanced with increasing dose, while safety outcomes remain consistent with those of the licensed dose (50 U). AIMS: Evaluation of subject‐reported indicators of treatment efficacy, satisfaction, and psychological well‐being with ABO dose escalation. METHODS: A Phase 2, 36‐week, multicenter, randomized, dose‐ranging, double‐blind, placebo‐controlled study was conducted in adults with moderate to severe glabellar lines. Subjects received a single ABO treatment, dosed at 50, 75, 100, or 125 U, or placebo. Efficacy endpoints comprised subject‐assessed improvement in line severity of ≥1‐grade from baseline at maximum frown, global aesthetic improvement scale (GAIS) grade, FACE‐Q™ appraisal of lines, psychological well‐being and age, and subject satisfaction. RESULTS: The study included 399 subjects (88.2% were female). Respective responder rates (≥1‐grade improvement) with ABO 50–125 U doses ranged between 96.3%–100% at Week 4, 65.0%–67.9% at Week 24, and 33.8%–44.4% at Week 36. GAIS responder rate and FACE‐Q appraisal of lines showed a similar pattern of change. Satisfaction was high and psychological well‐being was improved from Week 4 through Week 36, with natural, youthful, and refreshed appearance reported for all ABO doses. CONCLUSIONS: A single ABO treatment (dosed at 50–125 U) provided significant and sustained improvements in glabellar line severity over durations up to 36 weeks, versus placebo. Treatment satisfaction was high with all doses. Participants reported natural and youthful appearance, alongside improvements in psychological well‐being. |
format | Online Article Text |
id | pubmed-9322427 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-93224272022-07-30 Subject satisfaction and psychological well‐being with escalating abobotulinumtoxinA injection dose for the treatment of moderate to severe glabellar lines Dayan, Steven Joseph, John Moradi, Amir Lorenc, Z. Paul Coleman, Kyle Ablon, Glynis Kaufman‐Janette, Joely Cox, Sue Ellen Campbell, Andrew Munavalli, Girish Prygova, Inna J Cosmet Dermatol Injectable Articles BACKGROUND: Previous studies indicate that the efficacy and durability of a single AbobotulinumtoxinA (ABO) treatment for moderate to severe glabellar lines may be enhanced with increasing dose, while safety outcomes remain consistent with those of the licensed dose (50 U). AIMS: Evaluation of subject‐reported indicators of treatment efficacy, satisfaction, and psychological well‐being with ABO dose escalation. METHODS: A Phase 2, 36‐week, multicenter, randomized, dose‐ranging, double‐blind, placebo‐controlled study was conducted in adults with moderate to severe glabellar lines. Subjects received a single ABO treatment, dosed at 50, 75, 100, or 125 U, or placebo. Efficacy endpoints comprised subject‐assessed improvement in line severity of ≥1‐grade from baseline at maximum frown, global aesthetic improvement scale (GAIS) grade, FACE‐Q™ appraisal of lines, psychological well‐being and age, and subject satisfaction. RESULTS: The study included 399 subjects (88.2% were female). Respective responder rates (≥1‐grade improvement) with ABO 50–125 U doses ranged between 96.3%–100% at Week 4, 65.0%–67.9% at Week 24, and 33.8%–44.4% at Week 36. GAIS responder rate and FACE‐Q appraisal of lines showed a similar pattern of change. Satisfaction was high and psychological well‐being was improved from Week 4 through Week 36, with natural, youthful, and refreshed appearance reported for all ABO doses. CONCLUSIONS: A single ABO treatment (dosed at 50–125 U) provided significant and sustained improvements in glabellar line severity over durations up to 36 weeks, versus placebo. Treatment satisfaction was high with all doses. Participants reported natural and youthful appearance, alongside improvements in psychological well‐being. John Wiley and Sons Inc. 2022-04-12 2022-06 /pmc/articles/PMC9322427/ /pubmed/35266281 http://dx.doi.org/10.1111/jocd.14906 Text en © 2022 The Authors. Journal of Cosmetic Dermatology published by Wiley Periodicals LLC. https://creativecommons.org/licenses/by/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Injectable Articles Dayan, Steven Joseph, John Moradi, Amir Lorenc, Z. Paul Coleman, Kyle Ablon, Glynis Kaufman‐Janette, Joely Cox, Sue Ellen Campbell, Andrew Munavalli, Girish Prygova, Inna Subject satisfaction and psychological well‐being with escalating abobotulinumtoxinA injection dose for the treatment of moderate to severe glabellar lines |
title | Subject satisfaction and psychological well‐being with escalating abobotulinumtoxinA injection dose for the treatment of moderate to severe glabellar lines |
title_full | Subject satisfaction and psychological well‐being with escalating abobotulinumtoxinA injection dose for the treatment of moderate to severe glabellar lines |
title_fullStr | Subject satisfaction and psychological well‐being with escalating abobotulinumtoxinA injection dose for the treatment of moderate to severe glabellar lines |
title_full_unstemmed | Subject satisfaction and psychological well‐being with escalating abobotulinumtoxinA injection dose for the treatment of moderate to severe glabellar lines |
title_short | Subject satisfaction and psychological well‐being with escalating abobotulinumtoxinA injection dose for the treatment of moderate to severe glabellar lines |
title_sort | subject satisfaction and psychological well‐being with escalating abobotulinumtoxina injection dose for the treatment of moderate to severe glabellar lines |
topic | Injectable Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9322427/ https://www.ncbi.nlm.nih.gov/pubmed/35266281 http://dx.doi.org/10.1111/jocd.14906 |
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