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Significantly Increased Patient Satisfaction Following Liquid Formulation AbobotulinumtoxinA Treatment in Glabellar Lines: FACE-Q Outcomes From a Phase 3 Clinical Trial

BACKGROUND: The FACE-Q patient-reported outcome assesses patient experiences/outcomes with aesthetic facial procedure. A recent trial of abobotulinumtoxinA (ASI, liquid formulation) was the first to our knowledge to assess satisfaction with FACE-Q after glabellar line (GL) injection. OBJECTIVES: The...

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Autores principales: Ascher, Benjamin, Rzany, Berthold, Kestemont, Philippe, Hilton, Said, Heckmann, Marc, Bodokh, Isaac, Noah, Ernst Magnus, Boineau, Dominique, Kerscher, Martina, Volteau, Magali, Le Berre, Philippe, Picaut, Philippe
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7427150/
https://www.ncbi.nlm.nih.gov/pubmed/31550352
http://dx.doi.org/10.1093/asj/sjz248
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author Ascher, Benjamin
Rzany, Berthold
Kestemont, Philippe
Hilton, Said
Heckmann, Marc
Bodokh, Isaac
Noah, Ernst Magnus
Boineau, Dominique
Kerscher, Martina
Volteau, Magali
Le Berre, Philippe
Picaut, Philippe
author_facet Ascher, Benjamin
Rzany, Berthold
Kestemont, Philippe
Hilton, Said
Heckmann, Marc
Bodokh, Isaac
Noah, Ernst Magnus
Boineau, Dominique
Kerscher, Martina
Volteau, Magali
Le Berre, Philippe
Picaut, Philippe
author_sort Ascher, Benjamin
collection PubMed
description BACKGROUND: The FACE-Q patient-reported outcome assesses patient experiences/outcomes with aesthetic facial procedure. A recent trial of abobotulinumtoxinA (ASI, liquid formulation) was the first to our knowledge to assess satisfaction with FACE-Q after glabellar line (GL) injection. OBJECTIVES: The authors sought to evaluate patient satisfaction with ASI for GL treatment employing 3 FACE-Q scales: facial appearance, psychological well-being, and aging appearance. METHODS: This was a Phase 3, randomized, double-blind, placebo-controlled trial (NCT02353871) of ASI 50 units in adults with moderate-to-severe GL with 6-month follow-up. RESULTS: Significantly greater least squares mean changes from baseline were associated with ASI treatment (N = 125) vs placebo (N = 59) for satisfaction with facial appearance at all visits until day 148 (5 months; P < 0.0001-0.0037), psychological well-being at all visits (P < 0.0001-0.0279), and aging appearance at all visits except day 148 (P < 0.0001-0.0409). Significant differences (ASI vs placebo) were observed at all visits for individual items: “how rested your face looks” (P < 0.0001-0.0415), “I feel okay about myself” (P = 0.0011-0.0399), and “I feel attractive” (P < 0.0001-0.0102). Maximal least squares mean (standard error) changes in aging appearance score were −1.4 (0.3; ASI) and −0.3 (0.4; placebo). Investigators’ live assessment of GL at maximum frown significantly correlated with improvements in FACE-Q facial appearance and psychological scales (all patients: r = −0.41 and r = −0.36 [both P < 0.0001], respectively). CONCLUSIONS: Significant improvements in patient satisfaction with aging, facial appearance, and, importantly, psychological well-being were demonstrated with ASI employing FACE-Q scales up to 5 to 6 months post-injection. Results support a long duration of efficacy with ASI and use of FACE-Q in future trials and clinical practice. LEVEL OF EVIDENCE: 1: [Image: see text]
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spelling pubmed-74271502020-08-18 Significantly Increased Patient Satisfaction Following Liquid Formulation AbobotulinumtoxinA Treatment in Glabellar Lines: FACE-Q Outcomes From a Phase 3 Clinical Trial Ascher, Benjamin Rzany, Berthold Kestemont, Philippe Hilton, Said Heckmann, Marc Bodokh, Isaac Noah, Ernst Magnus Boineau, Dominique Kerscher, Martina Volteau, Magali Le Berre, Philippe Picaut, Philippe Aesthet Surg J Body Contouring BACKGROUND: The FACE-Q patient-reported outcome assesses patient experiences/outcomes with aesthetic facial procedure. A recent trial of abobotulinumtoxinA (ASI, liquid formulation) was the first to our knowledge to assess satisfaction with FACE-Q after glabellar line (GL) injection. OBJECTIVES: The authors sought to evaluate patient satisfaction with ASI for GL treatment employing 3 FACE-Q scales: facial appearance, psychological well-being, and aging appearance. METHODS: This was a Phase 3, randomized, double-blind, placebo-controlled trial (NCT02353871) of ASI 50 units in adults with moderate-to-severe GL with 6-month follow-up. RESULTS: Significantly greater least squares mean changes from baseline were associated with ASI treatment (N = 125) vs placebo (N = 59) for satisfaction with facial appearance at all visits until day 148 (5 months; P < 0.0001-0.0037), psychological well-being at all visits (P < 0.0001-0.0279), and aging appearance at all visits except day 148 (P < 0.0001-0.0409). Significant differences (ASI vs placebo) were observed at all visits for individual items: “how rested your face looks” (P < 0.0001-0.0415), “I feel okay about myself” (P = 0.0011-0.0399), and “I feel attractive” (P < 0.0001-0.0102). Maximal least squares mean (standard error) changes in aging appearance score were −1.4 (0.3; ASI) and −0.3 (0.4; placebo). Investigators’ live assessment of GL at maximum frown significantly correlated with improvements in FACE-Q facial appearance and psychological scales (all patients: r = −0.41 and r = −0.36 [both P < 0.0001], respectively). CONCLUSIONS: Significant improvements in patient satisfaction with aging, facial appearance, and, importantly, psychological well-being were demonstrated with ASI employing FACE-Q scales up to 5 to 6 months post-injection. Results support a long duration of efficacy with ASI and use of FACE-Q in future trials and clinical practice. LEVEL OF EVIDENCE: 1: [Image: see text] Oxford University Press 2020-08 2019-09-24 /pmc/articles/PMC7427150/ /pubmed/31550352 http://dx.doi.org/10.1093/asj/sjz248 Text en © 2019 The American Society for Aesthetic Plastic Surgery, Inc. http://creativecommons.org/licenses/by-nc/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
spellingShingle Body Contouring
Ascher, Benjamin
Rzany, Berthold
Kestemont, Philippe
Hilton, Said
Heckmann, Marc
Bodokh, Isaac
Noah, Ernst Magnus
Boineau, Dominique
Kerscher, Martina
Volteau, Magali
Le Berre, Philippe
Picaut, Philippe
Significantly Increased Patient Satisfaction Following Liquid Formulation AbobotulinumtoxinA Treatment in Glabellar Lines: FACE-Q Outcomes From a Phase 3 Clinical Trial
title Significantly Increased Patient Satisfaction Following Liquid Formulation AbobotulinumtoxinA Treatment in Glabellar Lines: FACE-Q Outcomes From a Phase 3 Clinical Trial
title_full Significantly Increased Patient Satisfaction Following Liquid Formulation AbobotulinumtoxinA Treatment in Glabellar Lines: FACE-Q Outcomes From a Phase 3 Clinical Trial
title_fullStr Significantly Increased Patient Satisfaction Following Liquid Formulation AbobotulinumtoxinA Treatment in Glabellar Lines: FACE-Q Outcomes From a Phase 3 Clinical Trial
title_full_unstemmed Significantly Increased Patient Satisfaction Following Liquid Formulation AbobotulinumtoxinA Treatment in Glabellar Lines: FACE-Q Outcomes From a Phase 3 Clinical Trial
title_short Significantly Increased Patient Satisfaction Following Liquid Formulation AbobotulinumtoxinA Treatment in Glabellar Lines: FACE-Q Outcomes From a Phase 3 Clinical Trial
title_sort significantly increased patient satisfaction following liquid formulation abobotulinumtoxina treatment in glabellar lines: face-q outcomes from a phase 3 clinical trial
topic Body Contouring
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7427150/
https://www.ncbi.nlm.nih.gov/pubmed/31550352
http://dx.doi.org/10.1093/asj/sjz248
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