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Efficacy, Safety, and Subject Satisfaction of PrabotulinumtoxinA for Moderate-to-Severe Crow’s Feet: A Phase IV, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial

PrabotulinumtoxinA has been identified as an effective agent against crow’s feet. Our study, which included Korean patients with moderate to severe crow’s feet, was undertaken to compare the efficacy and safety of PrabotulinumtoxinA and placebo treatments. Of the 90 study participants, 60 received p...

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Autores principales: Lee, Soo-Kyung, Kim, Myoung Shin, Kwon, Soon-Hyo, Chung, Bo Young, Han, Se Hee, Kim, Hyoung Jun
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10573474/
https://www.ncbi.nlm.nih.gov/pubmed/37834970
http://dx.doi.org/10.3390/jcm12196326
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author Lee, Soo-Kyung
Kim, Myoung Shin
Kwon, Soon-Hyo
Chung, Bo Young
Han, Se Hee
Kim, Hyoung Jun
author_facet Lee, Soo-Kyung
Kim, Myoung Shin
Kwon, Soon-Hyo
Chung, Bo Young
Han, Se Hee
Kim, Hyoung Jun
author_sort Lee, Soo-Kyung
collection PubMed
description PrabotulinumtoxinA has been identified as an effective agent against crow’s feet. Our study, which included Korean patients with moderate to severe crow’s feet, was undertaken to compare the efficacy and safety of PrabotulinumtoxinA and placebo treatments. Of the 90 study participants, 60 received prabotulinumtoxinA (24 U), whereas 30 received a placebo. The primary outcome assessment included facial wrinkle grading by investigators. At week 4, 69.64% of patients in the prabotulinumtoxinA group exhibited minimal crow’s feet severity; in contrast, a 0% improvement was observed in the placebo group (p < 0.0001). At week 12, the improvement rates were 30.36% for prabotulinumtoxinA and 6.90% for the placebo, demonstrating a significant difference (p = 0.0152). Based on the independent review panel’s assessment at week 4, the improvement rate was 39.29% in the prabotulinumtoxinA group and 3.45% in the placebo group during maximum smiling. Additionally, patient satisfaction was notably higher in the prabotulinumtoxinA group (32.14%) than in the placebo group (10.34%) at week 4 (p = 0.0289). Both treatments displayed comparable safety profiles, with only mild local reactions reported as ADRs for one patient from the prabotulinumtoxinA group. Thus, prabotulinumtoxinA demonstrates significant potential as a potent and safe remedy for crow’s feet.
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spelling pubmed-105734742023-10-14 Efficacy, Safety, and Subject Satisfaction of PrabotulinumtoxinA for Moderate-to-Severe Crow’s Feet: A Phase IV, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial Lee, Soo-Kyung Kim, Myoung Shin Kwon, Soon-Hyo Chung, Bo Young Han, Se Hee Kim, Hyoung Jun J Clin Med Article PrabotulinumtoxinA has been identified as an effective agent against crow’s feet. Our study, which included Korean patients with moderate to severe crow’s feet, was undertaken to compare the efficacy and safety of PrabotulinumtoxinA and placebo treatments. Of the 90 study participants, 60 received prabotulinumtoxinA (24 U), whereas 30 received a placebo. The primary outcome assessment included facial wrinkle grading by investigators. At week 4, 69.64% of patients in the prabotulinumtoxinA group exhibited minimal crow’s feet severity; in contrast, a 0% improvement was observed in the placebo group (p < 0.0001). At week 12, the improvement rates were 30.36% for prabotulinumtoxinA and 6.90% for the placebo, demonstrating a significant difference (p = 0.0152). Based on the independent review panel’s assessment at week 4, the improvement rate was 39.29% in the prabotulinumtoxinA group and 3.45% in the placebo group during maximum smiling. Additionally, patient satisfaction was notably higher in the prabotulinumtoxinA group (32.14%) than in the placebo group (10.34%) at week 4 (p = 0.0289). Both treatments displayed comparable safety profiles, with only mild local reactions reported as ADRs for one patient from the prabotulinumtoxinA group. Thus, prabotulinumtoxinA demonstrates significant potential as a potent and safe remedy for crow’s feet. MDPI 2023-10-01 /pmc/articles/PMC10573474/ /pubmed/37834970 http://dx.doi.org/10.3390/jcm12196326 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Lee, Soo-Kyung
Kim, Myoung Shin
Kwon, Soon-Hyo
Chung, Bo Young
Han, Se Hee
Kim, Hyoung Jun
Efficacy, Safety, and Subject Satisfaction of PrabotulinumtoxinA for Moderate-to-Severe Crow’s Feet: A Phase IV, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial
title Efficacy, Safety, and Subject Satisfaction of PrabotulinumtoxinA for Moderate-to-Severe Crow’s Feet: A Phase IV, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial
title_full Efficacy, Safety, and Subject Satisfaction of PrabotulinumtoxinA for Moderate-to-Severe Crow’s Feet: A Phase IV, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial
title_fullStr Efficacy, Safety, and Subject Satisfaction of PrabotulinumtoxinA for Moderate-to-Severe Crow’s Feet: A Phase IV, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial
title_full_unstemmed Efficacy, Safety, and Subject Satisfaction of PrabotulinumtoxinA for Moderate-to-Severe Crow’s Feet: A Phase IV, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial
title_short Efficacy, Safety, and Subject Satisfaction of PrabotulinumtoxinA for Moderate-to-Severe Crow’s Feet: A Phase IV, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial
title_sort efficacy, safety, and subject satisfaction of prabotulinumtoxina for moderate-to-severe crow’s feet: a phase iv, multicenter, double-blind, randomized, placebo-controlled trial
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10573474/
https://www.ncbi.nlm.nih.gov/pubmed/37834970
http://dx.doi.org/10.3390/jcm12196326
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