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Treatment of hyperhidrosis with Botox (onabotulinumtoxinA): Development, insights, and impact
Hyperhidrosis (chronic excessive sweating) may substantially affect an individual’s emotional and social well-being. Therapies available before onabotulinumtoxinA were generally topical, with limited effectiveness, application-site skin reactions, and frequent, time-consuming treatments. Intradermal...
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Lippincott Williams & Wilkins
2023
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10374185/ https://www.ncbi.nlm.nih.gov/pubmed/37499084 http://dx.doi.org/10.1097/MD.0000000000032764 |
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author | Lowe, Nicholas Naumann, Markus Eadie, Nina |
author_facet | Lowe, Nicholas Naumann, Markus Eadie, Nina |
author_sort | Lowe, Nicholas |
collection | PubMed |
description | Hyperhidrosis (chronic excessive sweating) may substantially affect an individual’s emotional and social well-being. Therapies available before onabotulinumtoxinA were generally topical, with limited effectiveness, application-site skin reactions, and frequent, time-consuming treatments. Intradermal injection of onabotulinumtoxinA to treat sweat glands arose as a novel therapeutic approach. To develop this treatment, appropriate dosing needed to be established, and training on administration was required. Further, no previous scale existed to measure the effects of hyperhidrosis on patients’ lives, leading Allergan to develop and validate the 4-point Hyperhidrosis Disease Severity Scale (HDSS), which measures the disease’s impact on daily activities. The onabotulinumtoxinA clinical development program for hyperhidrosis included 2 double-blind, placebo-controlled pivotal trials, immunogenicity studies, long-term studies of safety and efficacy, and quality of life assessments. In Europe and North America, the primary efficacy measures were, respectively, axillary sweat production measured gravimetrically and HDSS improvement. Compared with placebo, onabotulinumtoxinA treatment significantly reduced axillary sweat production and axillary hyperhidrosis severity, as measured by a 2-point or greater reduction on the HDSS. The effects of onabotulinumtoxinA occurred rapidly, within 1 week after injection, and lasted ≥6 months. Treatment with onabotulinumtoxinA was associated with significant quality of life improvements based on Short Form-12 physical and mental component scores. The Hyperhidrosis Impact Questionnaire also indicated greater treatment satisfaction, reduced negative impact on aspects of daily life, and improved emotional well-being with onabotulinumtoxinA versus placebo. The clinical development program and subsequent clinical experience showed that onabotulinumtoxinA treatment for hyperhidrosis was well tolerated with no new safety signals, and led to greater disease awareness. |
format | Online Article Text |
id | pubmed-10374185 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Lippincott Williams & Wilkins |
record_format | MEDLINE/PubMed |
spelling | pubmed-103741852023-07-28 Treatment of hyperhidrosis with Botox (onabotulinumtoxinA): Development, insights, and impact Lowe, Nicholas Naumann, Markus Eadie, Nina Medicine (Baltimore) OA Supplement Article Hyperhidrosis (chronic excessive sweating) may substantially affect an individual’s emotional and social well-being. Therapies available before onabotulinumtoxinA were generally topical, with limited effectiveness, application-site skin reactions, and frequent, time-consuming treatments. Intradermal injection of onabotulinumtoxinA to treat sweat glands arose as a novel therapeutic approach. To develop this treatment, appropriate dosing needed to be established, and training on administration was required. Further, no previous scale existed to measure the effects of hyperhidrosis on patients’ lives, leading Allergan to develop and validate the 4-point Hyperhidrosis Disease Severity Scale (HDSS), which measures the disease’s impact on daily activities. The onabotulinumtoxinA clinical development program for hyperhidrosis included 2 double-blind, placebo-controlled pivotal trials, immunogenicity studies, long-term studies of safety and efficacy, and quality of life assessments. In Europe and North America, the primary efficacy measures were, respectively, axillary sweat production measured gravimetrically and HDSS improvement. Compared with placebo, onabotulinumtoxinA treatment significantly reduced axillary sweat production and axillary hyperhidrosis severity, as measured by a 2-point or greater reduction on the HDSS. The effects of onabotulinumtoxinA occurred rapidly, within 1 week after injection, and lasted ≥6 months. Treatment with onabotulinumtoxinA was associated with significant quality of life improvements based on Short Form-12 physical and mental component scores. The Hyperhidrosis Impact Questionnaire also indicated greater treatment satisfaction, reduced negative impact on aspects of daily life, and improved emotional well-being with onabotulinumtoxinA versus placebo. The clinical development program and subsequent clinical experience showed that onabotulinumtoxinA treatment for hyperhidrosis was well tolerated with no new safety signals, and led to greater disease awareness. Lippincott Williams & Wilkins 2023-07-01 /pmc/articles/PMC10374185/ /pubmed/37499084 http://dx.doi.org/10.1097/MD.0000000000032764 Text en Copyright © 2023 the Author(s). Published by Wolters Kluwer Health, Inc. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND) (https://creativecommons.org/licenses/by-nc-nd/4.0/) , where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. |
spellingShingle | OA Supplement Article Lowe, Nicholas Naumann, Markus Eadie, Nina Treatment of hyperhidrosis with Botox (onabotulinumtoxinA): Development, insights, and impact |
title | Treatment of hyperhidrosis with Botox (onabotulinumtoxinA): Development, insights, and impact |
title_full | Treatment of hyperhidrosis with Botox (onabotulinumtoxinA): Development, insights, and impact |
title_fullStr | Treatment of hyperhidrosis with Botox (onabotulinumtoxinA): Development, insights, and impact |
title_full_unstemmed | Treatment of hyperhidrosis with Botox (onabotulinumtoxinA): Development, insights, and impact |
title_short | Treatment of hyperhidrosis with Botox (onabotulinumtoxinA): Development, insights, and impact |
title_sort | treatment of hyperhidrosis with botox (onabotulinumtoxina): development, insights, and impact |
topic | OA Supplement Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10374185/ https://www.ncbi.nlm.nih.gov/pubmed/37499084 http://dx.doi.org/10.1097/MD.0000000000032764 |
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