Respective potencies of Botox® and Dysport® in a human skin model: A randomized, double‐blind study
Identifieur interne : 002073 ( Main/Exploration ); précédent : 002072; suivant : 002074Respective potencies of Botox® and Dysport® in a human skin model: A randomized, double‐blind study
Auteurs : Gottfried Kranz [Autriche] ; Dietrich Haubenberger [Autriche] ; Bernhard Voller [Autriche] ; Martin Posch [Autriche] ; Peter Schnider [Autriche] ; Eduard Auff [Autriche] ; Thomas Sycha [Autriche]Source :
- Movement Disorders [ 0885-3185 ] ; 2009-01-30.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Homme.
English descriptors
- KwdEn :
- Abdomen, Adult, Bontoxilysin, Botulinum Toxins, Type A (administration & dosage), Botulinum Toxins, Type A (pharmacokinetics), Botulinum Toxins, Type A (pharmacology), Diffusion, Dose-Response Relationship, Drug, Double blind study, Double-Blind Method, Female, Hot Temperature, Human, Humans, Injections, Intradermal, Male, Models, Nervous system diseases, Reproducibility of Results, Skin, Skin (drug effects), Sweat, Sweating (drug effects), Young Adult, botulinum toxin A, dose unit ratio, ninhydrin sweat test, respective potencies.
- MESH :
- chemical , administration & dosage : Botulinum Toxins, Type A.
- chemical , pharmacokinetics : Botulinum Toxins, Type A.
- chemical , pharmacology : Botulinum Toxins, Type A.
- drug effects : Skin, Sweating.
- Abdomen, Adult, Diffusion, Dose-Response Relationship, Drug, Double-Blind Method, Female, Hot Temperature, Humans, Injections, Intradermal, Male, Reproducibility of Results, Young Adult.
Abstract
Mouse units used to quantify the activity of botulinum A toxin preparations are not equivalent and issues concerning efficacy and safety remain with regard to their respective potencies and diffusion qualities in human tissue. We compared the effects of Botox® (BOT) and Dysport® (DYS) in different doses and dilutions in a human skin model. Eighteen (8 women, 10 men) healthy volunteers, aged 28.4 years ± 5.7 years were injected intradermally with pure saline, BOT and DYS at 16 points in the abdomen in random order and in a double‐blind condition, using two conversion ratios (1:3 and 1:4) and three different dilution schemes. For an objective outcome, the Ninhydrin sweat test was used to compare the anhidrotic areas. Both preparations showed a linear dose and dilution relationship with similar variances of responses for anhidrosis and hypohidrosis, indicating the same reliability of response. The dose equivalence conversion ratios (BOT: DYS) were 1:1.3 for anhidrosis and 1:1.6 for hypohidrosis (1:1.1‐1.5 and 1:1.4‐1.8 95% confidence intervals). The diffusion characteristics of both products were similar. A dose equivalence factor of more than 1:2 (BOT:DYS) is not supported by these objective and reproducible data. © 2008 Movement Disorder Society
Url:
DOI: 10.1002/mds.22336
Affiliations:
Links toward previous steps (curation, corpus...)
- to stream Istex, to step Corpus: 001E73
- to stream Istex, to step Curation: 001E73
- to stream Istex, to step Checkpoint: 000C75
- to stream PubMed, to step Corpus: 001F74
- to stream PubMed, to step Curation: 001F74
- to stream PubMed, to step Checkpoint: 001B87
- to stream Ncbi, to step Merge: 002389
- to stream Ncbi, to step Curation: 002389
- to stream Ncbi, to step Checkpoint: 002389
- to stream Main, to step Merge: 002934
- to stream PascalFrancis, to step Corpus: 000F76
- to stream PascalFrancis, to step Curation: 001D43
- to stream PascalFrancis, to step Checkpoint: 000D18
- to stream Main, to step Merge: 002E15
- to stream Main, to step Curation: 002073
Le document en format XML
<record><TEI wicri:istexFullTextTei="biblStruct"><teiHeader><fileDesc><titleStmt><title xml:lang="en">Respective potencies of Botox® and Dysport® in a human skin model: A randomized, double‐blind study</title>
<author><name sortKey="Kranz, Gottfried" sort="Kranz, Gottfried" uniqKey="Kranz G" first="Gottfried" last="Kranz">Gottfried Kranz</name>
</author>
<author><name sortKey="Haubenberger, Dietrich" sort="Haubenberger, Dietrich" uniqKey="Haubenberger D" first="Dietrich" last="Haubenberger">Dietrich Haubenberger</name>
</author>
<author><name sortKey="Voller, Bernhard" sort="Voller, Bernhard" uniqKey="Voller B" first="Bernhard" last="Voller">Bernhard Voller</name>
</author>
<author><name sortKey="Posch, Martin" sort="Posch, Martin" uniqKey="Posch M" first="Martin" last="Posch">Martin Posch</name>
</author>
<author><name sortKey="Schnider, Peter" sort="Schnider, Peter" uniqKey="Schnider P" first="Peter" last="Schnider">Peter Schnider</name>
</author>
<author><name sortKey="Auff, Eduard" sort="Auff, Eduard" uniqKey="Auff E" first="Eduard" last="Auff">Eduard Auff</name>
</author>
<author><name sortKey="Sycha, Thomas" sort="Sycha, Thomas" uniqKey="Sycha T" first="Thomas" last="Sycha">Thomas Sycha</name>
</author>
</titleStmt>
<publicationStmt><idno type="wicri:source">ISTEX</idno>
<idno type="RBID">ISTEX:659C85D9163DDE3946E345437095DB5099F7C9D5</idno>
<date when="2009" year="2009">2009</date>
<idno type="doi">10.1002/mds.22336</idno>
<idno type="url">https://api.istex.fr/document/659C85D9163DDE3946E345437095DB5099F7C9D5/fulltext/pdf</idno>
<idno type="wicri:Area/Istex/Corpus">001E73</idno>
<idno type="wicri:Area/Istex/Curation">001E73</idno>
<idno type="wicri:Area/Istex/Checkpoint">000C75</idno>
<idno type="wicri:doubleKey">0885-3185:2009:Kranz G:respective:potencies:of</idno>
<idno type="wicri:source">PubMed</idno>
<idno type="RBID">pubmed:18951439</idno>
<idno type="wicri:Area/PubMed/Corpus">001F74</idno>
<idno type="wicri:Area/PubMed/Curation">001F74</idno>
<idno type="wicri:Area/PubMed/Checkpoint">001B87</idno>
<idno type="wicri:Area/Ncbi/Merge">002389</idno>
<idno type="wicri:Area/Ncbi/Curation">002389</idno>
<idno type="wicri:Area/Ncbi/Checkpoint">002389</idno>
<idno type="wicri:Area/Main/Merge">002934</idno>
<idno type="wicri:source">INIST</idno>
<idno type="RBID">Pascal:09-0104588</idno>
<idno type="wicri:Area/PascalFrancis/Corpus">000F76</idno>
<idno type="wicri:Area/PascalFrancis/Curation">001D43</idno>
<idno type="wicri:Area/PascalFrancis/Checkpoint">000D18</idno>
<idno type="wicri:doubleKey">0885-3185:2009:Kranz G:respective:potencies:of</idno>
<idno type="wicri:Area/Main/Merge">002E15</idno>
<idno type="wicri:Area/Main/Curation">002073</idno>
<idno type="wicri:Area/Main/Exploration">002073</idno>
</publicationStmt>
<sourceDesc><biblStruct><analytic><title level="a" type="main" xml:lang="en">Respective potencies of Botox® and Dysport® in a human skin model: A randomized, double‐blind study</title>
<author><name sortKey="Kranz, Gottfried" sort="Kranz, Gottfried" uniqKey="Kranz G" first="Gottfried" last="Kranz">Gottfried Kranz</name>
<affiliation wicri:level="3"><country xml:lang="fr">Autriche</country>
<wicri:regionArea>Department of Neurology, Medical University of Vienna, Wien</wicri:regionArea>
<placeName><settlement type="city">Vienne (Autriche)</settlement>
<region nuts="2" type="province">Vienne (Autriche)</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Haubenberger, Dietrich" sort="Haubenberger, Dietrich" uniqKey="Haubenberger D" first="Dietrich" last="Haubenberger">Dietrich Haubenberger</name>
<affiliation wicri:level="3"><country xml:lang="fr">Autriche</country>
<wicri:regionArea>Department of Neurology, Medical University of Vienna, Wien</wicri:regionArea>
<placeName><settlement type="city">Vienne (Autriche)</settlement>
<region nuts="2" type="province">Vienne (Autriche)</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Voller, Bernhard" sort="Voller, Bernhard" uniqKey="Voller B" first="Bernhard" last="Voller">Bernhard Voller</name>
<affiliation wicri:level="3"><country xml:lang="fr">Autriche</country>
<wicri:regionArea>Department of Neurology, Medical University of Vienna, Wien</wicri:regionArea>
<placeName><settlement type="city">Vienne (Autriche)</settlement>
<region nuts="2" type="province">Vienne (Autriche)</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Posch, Martin" sort="Posch, Martin" uniqKey="Posch M" first="Martin" last="Posch">Martin Posch</name>
<affiliation wicri:level="3"><country xml:lang="fr">Autriche</country>
<wicri:regionArea>Section of Medical Statistics, Core Unit for Medical Statistics and Informatics, Medical University of Vienna, Wien</wicri:regionArea>
<placeName><settlement type="city">Vienne (Autriche)</settlement>
<region nuts="2" type="province">Vienne (Autriche)</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Schnider, Peter" sort="Schnider, Peter" uniqKey="Schnider P" first="Peter" last="Schnider">Peter Schnider</name>
<affiliation wicri:level="1"><country xml:lang="fr">Autriche</country>
<wicri:regionArea>Department of Neurology, Landeskrankenhaus, Grimmenstein‐Hochegg</wicri:regionArea>
<wicri:noRegion>Grimmenstein‐Hochegg</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Auff, Eduard" sort="Auff, Eduard" uniqKey="Auff E" first="Eduard" last="Auff">Eduard Auff</name>
<affiliation wicri:level="3"><country xml:lang="fr">Autriche</country>
<wicri:regionArea>Department of Neurology, Medical University of Vienna, Wien</wicri:regionArea>
<placeName><settlement type="city">Vienne (Autriche)</settlement>
<region nuts="2" type="province">Vienne (Autriche)</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Sycha, Thomas" sort="Sycha, Thomas" uniqKey="Sycha T" first="Thomas" last="Sycha">Thomas Sycha</name>
<affiliation wicri:level="3"><country xml:lang="fr">Autriche</country>
<wicri:regionArea>Department of Neurology, Medical University of Vienna, Wien</wicri:regionArea>
<placeName><settlement type="city">Vienne (Autriche)</settlement>
<region nuts="2" type="province">Vienne (Autriche)</region>
</placeName>
</affiliation>
</author>
</analytic>
<monogr></monogr>
<series><title level="j">Movement Disorders</title>
<title level="j" type="sub">Official Journal of the Movement Disorder Society</title>
<title level="j" type="abbrev">Mov. Disord.</title>
<idno type="ISSN">0885-3185</idno>
<idno type="eISSN">1531-8257</idno>
<imprint><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher>
<pubPlace>Hoboken</pubPlace>
<date type="published" when="2009-01-30">2009-01-30</date>
<biblScope unit="vol">24</biblScope>
<biblScope unit="issue">2</biblScope>
<biblScope unit="page" from="231">231</biblScope>
<biblScope unit="page" to="236">236</biblScope>
</imprint>
<idno type="ISSN">0885-3185</idno>
</series>
<idno type="istex">659C85D9163DDE3946E345437095DB5099F7C9D5</idno>
<idno type="DOI">10.1002/mds.22336</idno>
<idno type="ArticleID">MDS22336</idno>
</biblStruct>
</sourceDesc>
<seriesStmt><idno type="ISSN">0885-3185</idno>
</seriesStmt>
</fileDesc>
<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Abdomen</term>
<term>Adult</term>
<term>Bontoxilysin</term>
<term>Botulinum Toxins, Type A (administration & dosage)</term>
<term>Botulinum Toxins, Type A (pharmacokinetics)</term>
<term>Botulinum Toxins, Type A (pharmacology)</term>
<term>Diffusion</term>
<term>Dose-Response Relationship, Drug</term>
<term>Double blind study</term>
<term>Double-Blind Method</term>
<term>Female</term>
<term>Hot Temperature</term>
<term>Human</term>
<term>Humans</term>
<term>Injections, Intradermal</term>
<term>Male</term>
<term>Models</term>
<term>Nervous system diseases</term>
<term>Reproducibility of Results</term>
<term>Skin</term>
<term>Skin (drug effects)</term>
<term>Sweat</term>
<term>Sweating (drug effects)</term>
<term>Young Adult</term>
<term>botulinum toxin A</term>
<term>dose unit ratio</term>
<term>ninhydrin sweat test</term>
<term>respective potencies</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Botulinum Toxins, Type A</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="pharmacokinetics" xml:lang="en"><term>Botulinum Toxins, Type A</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="pharmacology" xml:lang="en"><term>Botulinum Toxins, Type A</term>
</keywords>
<keywords scheme="MESH" qualifier="drug effects" xml:lang="en"><term>Skin</term>
<term>Sweating</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Abdomen</term>
<term>Adult</term>
<term>Diffusion</term>
<term>Dose-Response Relationship, Drug</term>
<term>Double-Blind Method</term>
<term>Female</term>
<term>Hot Temperature</term>
<term>Humans</term>
<term>Injections, Intradermal</term>
<term>Male</term>
<term>Reproducibility of Results</term>
<term>Young Adult</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Bontoxilysin</term>
<term>Etude double insu</term>
<term>Homme</term>
<term>Modèle</term>
<term>Pathologie du système nerveux</term>
<term>Peau</term>
<term>Sueur</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term>
</keywords>
</textClass>
<langUsage><language ident="en">en</language>
</langUsage>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en">Mouse units used to quantify the activity of botulinum A toxin preparations are not equivalent and issues concerning efficacy and safety remain with regard to their respective potencies and diffusion qualities in human tissue. We compared the effects of Botox® (BOT) and Dysport® (DYS) in different doses and dilutions in a human skin model. Eighteen (8 women, 10 men) healthy volunteers, aged 28.4 years ± 5.7 years were injected intradermally with pure saline, BOT and DYS at 16 points in the abdomen in random order and in a double‐blind condition, using two conversion ratios (1:3 and 1:4) and three different dilution schemes. For an objective outcome, the Ninhydrin sweat test was used to compare the anhidrotic areas. Both preparations showed a linear dose and dilution relationship with similar variances of responses for anhidrosis and hypohidrosis, indicating the same reliability of response. The dose equivalence conversion ratios (BOT: DYS) were 1:1.3 for anhidrosis and 1:1.6 for hypohidrosis (1:1.1‐1.5 and 1:1.4‐1.8 95% confidence intervals). The diffusion characteristics of both products were similar. A dose equivalence factor of more than 1:2 (BOT:DYS) is not supported by these objective and reproducible data. © 2008 Movement Disorder Society</div>
</front>
</TEI>
<affiliations><list><country><li>Autriche</li>
</country>
<region><li>Vienne (Autriche)</li>
</region>
<settlement><li>Vienne (Autriche)</li>
</settlement>
</list>
<tree><country name="Autriche"><region name="Vienne (Autriche)"><name sortKey="Kranz, Gottfried" sort="Kranz, Gottfried" uniqKey="Kranz G" first="Gottfried" last="Kranz">Gottfried Kranz</name>
</region>
<name sortKey="Auff, Eduard" sort="Auff, Eduard" uniqKey="Auff E" first="Eduard" last="Auff">Eduard Auff</name>
<name sortKey="Haubenberger, Dietrich" sort="Haubenberger, Dietrich" uniqKey="Haubenberger D" first="Dietrich" last="Haubenberger">Dietrich Haubenberger</name>
<name sortKey="Posch, Martin" sort="Posch, Martin" uniqKey="Posch M" first="Martin" last="Posch">Martin Posch</name>
<name sortKey="Schnider, Peter" sort="Schnider, Peter" uniqKey="Schnider P" first="Peter" last="Schnider">Peter Schnider</name>
<name sortKey="Sycha, Thomas" sort="Sycha, Thomas" uniqKey="Sycha T" first="Thomas" last="Sycha">Thomas Sycha</name>
<name sortKey="Voller, Bernhard" sort="Voller, Bernhard" uniqKey="Voller B" first="Bernhard" last="Voller">Bernhard Voller</name>
</country>
</tree>
</affiliations>
</record>
Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Wicri/Santé/explor/MovDisordV3/Data/Main/Exploration
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 002073 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/Main/Exploration/biblio.hfd -nk 002073 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien |wiki= Wicri/Santé |area= MovDisordV3 |flux= Main |étape= Exploration |type= RBID |clé= ISTEX:659C85D9163DDE3946E345437095DB5099F7C9D5 |texte= Respective potencies of Botox® and Dysport® in a human skin model: A randomized, double‐blind study }}
This area was generated with Dilib version V0.6.23. |