Respective potencies of Botox and Dysport in a human skin model: a randomized, double-blind study.
Identifieur interne : 001F74 ( PubMed/Curation ); précédent : 001F73; suivant : 001F75Respective potencies of Botox and Dysport in a human skin model: a randomized, double-blind study.
Auteurs : Gottfried Kranz [Autriche] ; Dietrich Haubenberger ; Bernhard Voller ; Martin Posch ; Peter Schnider ; Eduard Auff ; Thomas SychaSource :
- Movement disorders : official journal of the Movement Disorder Society [ 1531-8257 ] ; 2009.
English descriptors
- KwdEn :
- Abdomen, Adult, Botulinum Toxins, Type A (administration & dosage), Botulinum Toxins, Type A (pharmacokinetics), Botulinum Toxins, Type A (pharmacology), Diffusion, Dose-Response Relationship, Drug, Double-Blind Method, Female, Hot Temperature, Humans, Injections, Intradermal, Male, Reproducibility of Results, Skin (drug effects), Sweating (drug effects), Young Adult.
- 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.
DOI: 10.1002/mds.22336
PubMed: 18951439
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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">PubMed</idno><date when="2009">2009</date><idno type="doi">10.1002/mds.22336</idno><idno type="RBID">pubmed:18951439</idno><idno type="pmid">18951439</idno><idno type="wicri:Area/PubMed/Corpus">001F74</idno><idno type="wicri:Area/PubMed/Curation">001F74</idno></publicationStmt><sourceDesc><biblStruct><analytic><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><affiliation wicri:level="1"><nlm:affiliation>Department of Neurology, Medical University of Vienna, Wien, Austria.</nlm:affiliation><country xml:lang="fr">Autriche</country><wicri:regionArea>Department of Neurology, Medical University of Vienna, Wien</wicri:regionArea></affiliation></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></analytic><series><title level="j">Movement disorders : official journal of the Movement Disorder Society</title><idno type="eISSN">1531-8257</idno><imprint><date when="2009" type="published">2009</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Abdomen</term><term>Adult</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 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>Skin (drug effects)</term><term>Sweating (drug effects)</term><term>Young Adult</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></textClass></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.</div></front></TEI><pubmed><MedlineCitation Owner="NLM" Status="MEDLINE"><PMID Version="1">18951439</PMID><DateCreated><Year>2009</Year><Month>02</Month><Day>02</Day></DateCreated><DateCompleted><Year>2009</Year><Month>06</Month><Day>08</Day></DateCompleted><DateRevised><Year>2010</Year><Month>11</Month><Day>18</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Electronic">1531-8257</ISSN><JournalIssue CitedMedium="Internet"><Volume>24</Volume><Issue>2</Issue><PubDate><Year>2009</Year><Month>Jan</Month><Day>30</Day></PubDate></JournalIssue><Title>Movement disorders : official journal of the Movement Disorder Society</Title><ISOAbbreviation>Mov. Disord.</ISOAbbreviation></Journal><ArticleTitle>Respective potencies of Botox and Dysport in a human skin model: a randomized, double-blind study.</ArticleTitle><Pagination><MedlinePgn>231-6</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1002/mds.22336</ELocationID><Abstract><AbstractText>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.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Kranz</LastName><ForeName>Gottfried</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>Department of Neurology, Medical University of Vienna, Wien, Austria.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Haubenberger</LastName><ForeName>Dietrich</ForeName><Initials>D</Initials></Author><Author ValidYN="Y"><LastName>Voller</LastName><ForeName>Bernhard</ForeName><Initials>B</Initials></Author><Author ValidYN="Y"><LastName>Posch</LastName><ForeName>Martin</ForeName><Initials>M</Initials></Author><Author ValidYN="Y"><LastName>Schnider</LastName><ForeName>Peter</ForeName><Initials>P</Initials></Author><Author ValidYN="Y"><LastName>Auff</LastName><ForeName>Eduard</ForeName><Initials>E</Initials></Author><Author ValidYN="Y"><LastName>Sycha</LastName><ForeName>Thomas</ForeName><Initials>T</Initials></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D003160">Comparative Study</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Mov Disord</MedlineTA><NlmUniqueID>8610688</NlmUniqueID><ISSNLinking>0885-3185</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>EC 3.4.24.69</RegistryNumber><NameOfSubstance UI="D019274">Botulinum Toxins, Type A</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000005">Abdomen</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000328">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D019274">Botulinum Toxins, Type A</DescriptorName><QualifierName MajorTopicYN="N" UI="Q000008">administration & dosage</QualifierName><QualifierName MajorTopicYN="N" UI="Q000493">pharmacokinetics</QualifierName><QualifierName MajorTopicYN="Y" UI="Q000494">pharmacology</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D004058">Diffusion</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D004305">Dose-Response Relationship, Drug</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D004311">Double-Blind Method</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D005260">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D006358">Hot Temperature</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D006801">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D007271">Injections, Intradermal</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D008297">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D015203">Reproducibility of Results</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D012867">Skin</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000187">drug effects</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D013546">Sweating</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000187">drug effects</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D055815">Young Adult</DescriptorName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="pubmed"><Year>2008</Year><Month>10</Month><Day>28</Day><Hour>9</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2009</Year><Month>6</Month><Day>9</Day><Hour>9</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2008</Year><Month>10</Month><Day>28</Day><Hour>9</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="doi">10.1002/mds.22336</ArticleId><ArticleId IdType="pubmed">18951439</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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