Evaluation of the efficacy and safety of a CS20® protective barrier gel containing OGT compared with topical aciclovir and placebo on functional and objective symptoms of labial herpes recurrences: a randomized clinical trial
Identifieur interne : 000A06 ( Istex/Corpus ); précédent : 000A05; suivant : 000A07Evaluation of the efficacy and safety of a CS20® protective barrier gel containing OGT compared with topical aciclovir and placebo on functional and objective symptoms of labial herpes recurrences: a randomized clinical trial
Auteurs : A. Khemis ; L. Duteil ; A. C. Coudert ; Y. Tillet ; O. Dereure ; J. P. OrtonneSource :
- Journal of the European Academy of Dermatology and Venereology [ 0926-9959 ] ; 2012-10.
English descriptors
- KwdEn :
- Aciclovir, Aciclovir group, Acyclovir, Acyclovir cream, Antimicrob agents chemother, Antiviral, Antiviral activity, Authors journal, Baseline, Clinical scores, Dermatology, Endpoint, European academy, Functional symptoms, Herpes, Herpes episode, Herpes labialis, Herpes simplex labialis, Intensity score, Jeadv, Labial, Labial herpes, Labial recurrences, Labialis, Lesion, Lesion repair, Oedema, Oral lubricant solution, Oxygenated glycerol triesters, Pain intensity score, Penciclovir, Penciclovir cream, Percentage reduction, Placebo, Placebo group, Protective barrier, Randomized, Recurrence, Recurrent herpes labialis, Recurrent labial herpes, Secondary endpoints, Simplex, Subjective scores, Time point, Topical, Topical aciclovir, Topical aciclovir group, Topical therapy, Treatment groups, Unsightly appearance, Venereology, Venereology khemis.
- Teeft :
- Aciclovir, Aciclovir group, Acyclovir, Acyclovir cream, Antimicrob agents chemother, Antiviral, Antiviral activity, Authors journal, Baseline, Clinical scores, Dermatology, Endpoint, European academy, Functional symptoms, Herpes, Herpes episode, Herpes labialis, Herpes simplex labialis, Intensity score, Jeadv, Labial, Labial herpes, Labial recurrences, Labialis, Lesion, Lesion repair, Oedema, Oral lubricant solution, Oxygenated glycerol triesters, Pain intensity score, Penciclovir, Penciclovir cream, Percentage reduction, Placebo, Placebo group, Protective barrier, Randomized, Recurrence, Recurrent herpes labialis, Recurrent labial herpes, Secondary endpoints, Simplex, Subjective scores, Time point, Topical, Topical aciclovir, Topical aciclovir group, Topical therapy, Treatment groups, Unsightly appearance, Venereology, Venereology khemis.
Abstract
Background Topical or systemic antiviral drugs reduce the duration of herpes simplex virus 1 (HSV‐1) recurrences but may not alleviate functional symptoms.
Url:
DOI: 10.1111/j.1468-3083.2011.04269.x
Links to Exploration step
ISTEX:1450E6DD7D7326D61875E2B7F534873A886626BCLe document en format XML
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Duteil</name><affiliation><mods:affiliation>Service de Dermatologie, Hôpital L’Archet 2, 151, route de Saint Antoine de Ginestière, 06202 Nice Cedex 3, France</mods:affiliation></affiliation></author><author><name sortKey="Coudert, A C" sort="Coudert, A C" uniqKey="Coudert A" first="A. C." last="Coudert">A. C. Coudert</name><affiliation><mods:affiliation>Laboratoires Carilène, 7, rue du Chant des Oiseaux, 78360 Montesson, France</mods:affiliation></affiliation></author><author><name sortKey="Tillet, Y" sort="Tillet, Y" uniqKey="Tillet Y" first="Y." last="Tillet">Y. Tillet</name><affiliation><mods:affiliation>White‐Tillet Consultants & Experts 35, rue Franck Hémon, 77500 Chelles, France</mods:affiliation></affiliation></author><author><name sortKey="Dereure, O" sort="Dereure, O" uniqKey="Dereure O" first="O." last="Dereure">O. 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score</term><term>Penciclovir</term><term>Penciclovir cream</term><term>Percentage reduction</term><term>Placebo</term><term>Placebo group</term><term>Protective barrier</term><term>Randomized</term><term>Recurrence</term><term>Recurrent herpes labialis</term><term>Recurrent labial herpes</term><term>Secondary endpoints</term><term>Simplex</term><term>Subjective scores</term><term>Time point</term><term>Topical</term><term>Topical aciclovir</term><term>Topical aciclovir group</term><term>Topical therapy</term><term>Treatment groups</term><term>Unsightly appearance</term><term>Venereology</term><term>Venereology khemis</term></keywords><keywords scheme="Teeft" xml:lang="en"><term>Aciclovir</term><term>Aciclovir group</term><term>Acyclovir</term><term>Acyclovir cream</term><term>Antimicrob agents chemother</term><term>Antiviral</term><term>Antiviral activity</term><term>Authors journal</term><term>Baseline</term><term>Clinical scores</term><term>Dermatology</term><term>Endpoint</term><term>European academy</term><term>Functional symptoms</term><term>Herpes</term><term>Herpes episode</term><term>Herpes labialis</term><term>Herpes simplex labialis</term><term>Intensity score</term><term>Jeadv</term><term>Labial</term><term>Labial herpes</term><term>Labial recurrences</term><term>Labialis</term><term>Lesion</term><term>Lesion repair</term><term>Oedema</term><term>Oral lubricant solution</term><term>Oxygenated glycerol triesters</term><term>Pain intensity score</term><term>Penciclovir</term><term>Penciclovir cream</term><term>Percentage reduction</term><term>Placebo</term><term>Placebo group</term><term>Protective barrier</term><term>Randomized</term><term>Recurrence</term><term>Recurrent herpes labialis</term><term>Recurrent labial herpes</term><term>Secondary endpoints</term><term>Simplex</term><term>Subjective scores</term><term>Time point</term><term>Topical</term><term>Topical aciclovir</term><term>Topical 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Ortonne</name><affiliations><json:string>Service de Dermatologie, Hôpital L’Archet 2, 151, route de Saint Antoine de Ginestière, 06202 Nice Cedex 3, France</json:string><json:string>E-mail: ortonne@unice.fr</json:string></affiliations></json:item></author><articleId><json:string>JDV4269</json:string></articleId><arkIstex>ark:/67375/WNG-VR2Q5HQ1-7</arkIstex><language><json:string>eng</json:string></language><originalGenre><json:string>article</json:string></originalGenre><abstract>Background Topical or systemic antiviral drugs reduce the duration of herpes simplex virus 1 (HSV‐1) recurrences but may not alleviate functional symptoms.</abstract><qualityIndicators><score>6.921</score><pdfWordCount>4657</pdfWordCount><pdfCharCount>28451</pdfCharCount><pdfVersion>1.7</pdfVersion><pdfPageCount>7</pdfPageCount><pdfPageSize>595.276 x 782.362 pts</pdfPageSize><refBibsNative>true</refBibsNative><abstractWordCount>22</abstractWordCount><abstractCharCount>156</abstractCharCount><keywordCount>0</keywordCount></qualityIndicators><title>Evaluation of the efficacy and safety of a CS20® protective barrier gel containing OGT compared with topical aciclovir and placebo on functional and objective symptoms of labial herpes recurrences: a randomized clinical trial</title><pmid><json:string>21981375</json:string></pmid><genre><json:string>article</json:string></genre><host><title>Journal of the European Academy of Dermatology and Venereology</title><language><json:string>unknown</json:string></language><doi><json:string>10.1111/(ISSN)1468-3083</json:string></doi><issn><json:string>0926-9959</json:string></issn><eissn><json:string>1468-3083</json:string></eissn><publisherId><json:string>JDV</json:string></publisherId><volume>26</volume><issue>10</issue><pages><first>1240</first><last>1246</last><total>7</total></pages><genre><json:string>journal</json:string></genre><subject><json:item><value>ORIGINAL ARTICLE</value></json:item></subject></host><namedEntities><unitex><date><json:string>2012</json:string><json:string>2008</json:string></date><geogName></geogName><orgName><json:string>European Academy of Dermatology</json:string><json:string>Topical Penciclovir Clinical Study Group</json:string></orgName><orgName_funder></orgName_funder><orgName_provider></orgName_provider><persName><json:string>Y. Tillet</json:string><json:string>Outpatients</json:string><json:string>Marian</json:string><json:string>L. Duteil</json:string><json:string>O. Dereure</json:string><json:string>A.C. Coudert</json:string><json:string>Vanessa Lane</json:string><json:string>Journal</json:string><json:string>Franck Hemon</json:string><json:string>J.P. Ortonne</json:string></persName><placeName><json:string>Montpellier</json:string><json:string>US</json:string><json:string>Nice</json:string><json:string>Helsinki</json:string><json:string>France</json:string></placeName><ref_url></ref_url><ref_bibl><json:string>Khemis et al. 1242</json:string><json:string>Khemis et al. 1244</json:string></ref_bibl><bibl></bibl></unitex></namedEntities><ark><json:string>ark:/67375/WNG-VR2Q5HQ1-7</json:string></ark><categories><wos><json:string>1 - science</json:string><json:string>2 - dermatology</json:string></wos><scienceMetrix><json:string>1 - health sciences</json:string><json:string>2 - clinical medicine</json:string><json:string>3 - dermatology & venereal diseases</json:string></scienceMetrix><scopus><json:string>1 - Health Sciences</json:string><json:string>2 - Medicine</json:string><json:string>3 - Infectious Diseases</json:string><json:string>1 - Health Sciences</json:string><json:string>2 - Medicine</json:string><json:string>3 - Dermatology</json:string></scopus></categories><publicationDate>2012</publicationDate><copyrightDate>2012</copyrightDate><doi><json:string>10.1111/j.1468-3083.2011.04269.x</json:string></doi><id>1450E6DD7D7326D61875E2B7F534873A886626BC</id><score>1</score><fulltext><json:item><extension>pdf</extension><original>true</original><mimetype>application/pdf</mimetype><uri>https://api.istex.fr/document/1450E6DD7D7326D61875E2B7F534873A886626BC/fulltext/pdf</uri></json:item><json:item><extension>zip</extension><original>false</original><mimetype>application/zip</mimetype><uri>https://api.istex.fr/document/1450E6DD7D7326D61875E2B7F534873A886626BC/fulltext/zip</uri></json:item><istex:fulltextTEI uri="https://api.istex.fr/document/1450E6DD7D7326D61875E2B7F534873A886626BC/fulltext/tei"><teiHeader><fileDesc><titleStmt><title level="a" type="main">Evaluation of the efficacy and safety of a CS20<hi rend="superscript">®</hi> protective barrier gel containing OGT compared with topical aciclovir and placebo on functional and objective symptoms of labial herpes recurrences: a randomized clinical trial</title></titleStmt><publicationStmt><authority>ISTEX</authority><publisher>Blackwell Publishing Ltd</publisher><pubPlace>Oxford, UK</pubPlace><availability><licence>© 2011 The Authors. Journal of the European Academy of Dermatology and Venereology © 2011 European Academy of Dermatology and Venereology</licence></availability><date type="published" when="2012-10"></date></publicationStmt><notesStmt><note type="content-type" subtype="article" source="article" scheme="https://content-type.data.istex.fr/ark:/67375/XTP-6N5SZHKN-D">article</note><note type="publication-type" subtype="journal" scheme="https://publication-type.data.istex.fr/ark:/67375/JMC-0GLKJH51-B">journal</note></notesStmt><sourceDesc><biblStruct type="article"><analytic><title level="a" type="main">Evaluation of the efficacy and safety of a CS20<hi rend="superscript">®</hi> protective barrier gel containing OGT compared with topical aciclovir and placebo on functional and objective symptoms of labial herpes recurrences: a randomized clinical trial</title><title level="a" type="short">Efficacy and safety of OGT protective barrier gel in labial herpes</title><author xml:id="author-0000"><persName><forename type="first">A.</forename><surname>Khemis</surname></persName><affiliation>Service de Dermatologie, Hôpital L’Archet 2, 151, route de Saint Antoine de Ginestière, 06202 Nice Cedex 3, France<address><country key="FR"></country></address></affiliation></author><author xml:id="author-0001"><persName><forename type="first">L.</forename><surname>Duteil</surname></persName><affiliation>Service de Dermatologie, Hôpital L’Archet 2, 151, route de Saint Antoine de Ginestière, 06202 Nice Cedex 3, France<address><country key="FR"></country></address></affiliation></author><author xml:id="author-0002"><persName><forename type="first">A.C.</forename><surname>Coudert</surname></persName><affiliation>Laboratoires Carilène, 7, rue du Chant des Oiseaux, 78360 Montesson, France<address><country key="FR"></country></address></affiliation></author><author xml:id="author-0003"><persName><forename type="first">Y.</forename><surname>Tillet</surname></persName><affiliation>White‐Tillet Consultants & Experts 35, rue Franck Hémon, 77500 Chelles, France<address><country key="FR"></country></address></affiliation></author><author xml:id="author-0004"><persName><forename type="first">O.</forename><surname>Dereure</surname></persName><affiliation>Service de Dermatologie, Hôpital Saint‐Eloi, 80 avenue A Fliche, 34295 Montpellier Cedex 5, France<address><country key="FR"></country></address></affiliation></author><author xml:id="author-0005" role="corresp"><persName><forename type="first">J.P.</forename><surname>Ortonne</surname></persName><affiliation>Service de Dermatologie, Hôpital L’Archet 2, 151, route de Saint Antoine de Ginestière, 06202 Nice Cedex 3, France<address><country key="FR"></country></address></affiliation><affiliation>J.P. Ortonne. E‐mail:ortonne@unice.fr</affiliation></author><idno type="istex">1450E6DD7D7326D61875E2B7F534873A886626BC</idno><idno type="ark">ark:/67375/WNG-VR2Q5HQ1-7</idno><idno type="DOI">10.1111/j.1468-3083.2011.04269.x</idno><idno type="unit">JDV4269</idno><idno type="toTypesetVersion">file:JDV.JDV4269.pdf</idno></analytic><monogr><title level="j" type="main">Journal of the European Academy of Dermatology and Venereology</title><title level="j" type="alt">JOURNAL OF EUROPEAN ACADEMY DERMATOLOGY VENEREOLOGY</title><idno type="pISSN">0926-9959</idno><idno type="eISSN">1468-3083</idno><idno type="book-DOI">10.1111/(ISSN)1468-3083</idno><idno type="book-part-DOI">10.1111/jdv.2012.26.issue-10</idno><idno type="product">JDV</idno><idno type="publisherDivision">ST</idno><imprint><biblScope unit="vol">26</biblScope><biblScope unit="issue">10</biblScope><biblScope unit="page" from="1240">1240</biblScope><biblScope unit="page" to="1246">1246</biblScope><biblScope unit="page-count">7</biblScope><publisher>Blackwell Publishing Ltd</publisher><pubPlace>Oxford, UK</pubPlace><date type="published" when="2012-10"></date></imprint></monogr></biblStruct></sourceDesc></fileDesc><profileDesc><abstract xml:lang="en" style="main"><head>Abstract</head><p><hi rend="bold">Background </hi> Topical or systemic antiviral drugs reduce the duration of herpes simplex virus 1 (HSV‐1) recurrences but may not alleviate functional symptoms.</p><p><hi rend="bold">Objectives </hi> To assess the efficacy and safety of CS20 (Acura 24<hi rend="superscript">®</hi>) protective barrier gel versus topical aciclovir and placebo in resolving functional symptoms in HSV‐1 labial recurrences.</p><p><hi rend="bold">Methods </hi> A prospective, randomized, single‐centre, assessor‐blinded study of CS20 versus topical aciclovir or placebo. The primary endpoint was the total score of four herpes‐related functional symptoms (pain, burning, itching, and tingling sensations), evaluated by visual analogue scale (VAS). Secondary endpoints encompassed objective skin changes (oedema, crusting and erythema), evaluated by specific clinical scores.</p><p><hi rend="bold">Results </hi> In a study of 106 patients, compared with placebo, a significant improvement in total functional symptom score was observed after 1 day of treatment in the CS20 group, but only after 7 days of treatment in the topical aciclovir group. Burning sensations were significantly reduced by CS20 compared with aciclovir (Days 1–2) or placebo (Days 1–7). Compared to placebo, CS20 significantly reduced pain intensity on Days 1–6. CS20 induced significant and early improvements in the clinical scores for oedema and crusting compared with placebo. Time to cure was similar for CS20 and aciclovir. The treatments were well tolerated and adverse events were comparable in the three treatment groups.</p><p><hi rend="bold">Limitations </hi> The single‐centre and single‐blind design of the study and the preselection of patients.</p><p><hi rend="bold">Conclusion </hi> CS20 showed superior effectiveness against functional symptoms (pain and burning) associated with HSV‐1 labial recurrences and was similar to aciclovir for time to cure.</p></abstract><textClass><keywords rend="tocHeading1"><term>ORIGINAL ARTICLES</term></keywords><keywords rend="articleCategory"><term>ORIGINAL ARTICLE</term></keywords></textClass><langUsage><language ident="en"></language></langUsage></profileDesc></teiHeader></istex:fulltextTEI><json:item><extension>txt</extension><original>false</original><mimetype>text/plain</mimetype><uri>https://api.istex.fr/document/1450E6DD7D7326D61875E2B7F534873A886626BC/fulltext/txt</uri></json:item></fulltext><metadata><istex:metadataXml wicri:clean="Wiley, elements deleted: body"><istex:xmlDeclaration>version="1.0" encoding="UTF-8" standalone="yes"</istex:xmlDeclaration><istex:document><component version="2.0" type="serialArticle" xml:lang="en"><header><publicationMeta level="product"><publisherInfo><publisherName>Blackwell Publishing Ltd</publisherName><publisherLoc>Oxford, UK</publisherLoc></publisherInfo><doi origin="wiley" registered="yes">10.1111/(ISSN)1468-3083</doi><issn type="print">0926-9959</issn><issn type="electronic">1468-3083</issn><idGroup><id type="product" value="JDV"></id><id type="publisherDivision" value="ST"></id></idGroup><titleGroup><title type="main" sort="JOURNAL OF EUROPEAN ACADEMY DERMATOLOGY VENEREOLOGY">Journal of the European Academy of Dermatology and Venereology</title></titleGroup></publicationMeta><publicationMeta level="part" position="10110"><doi origin="wiley">10.1111/jdv.2012.26.issue-10</doi><numberingGroup><numbering type="journalVolume" number="26">26</numbering><numbering type="journalIssue" number="10">10</numbering></numberingGroup><coverDate startDate="2012-10">October 2012</coverDate></publicationMeta><publicationMeta level="unit" type="article" position="8" status="forIssue"><doi origin="wiley">10.1111/j.1468-3083.2011.04269.x</doi><idGroup><id type="unit" value="JDV4269"></id></idGroup><countGroup><count type="pageTotal" number="7"></count></countGroup><titleGroup><title type="tocHeading1">ORIGINAL ARTICLES</title><title type="articleCategory">ORIGINAL ARTICLE</title></titleGroup><copyright>© 2011 The Authors. Journal of the European Academy of Dermatology and Venereology © 2011 European Academy of Dermatology and Venereology</copyright><eventGroup><event type="xmlConverted" agent="Converter:BPG_TO_WML3G version:3.1.6 mode:FullText" date="2012-09-10"></event><event type="publishedOnlineEarlyUnpaginated" date="2011-10-10"></event><event type="firstOnline" date="2011-10-10"></event><event type="publishedOnlineFinalForm" date="2012-09-10"></event><event type="xmlConverted" agent="Converter:WILEY_ML3G_TO_WILEY_ML3GV2 version:4.0.1" date="2014-03-19"></event><event type="xmlConverted" agent="Converter:WML3G_To_WML3G version:4.3.4 mode:FullText" date="2015-02-25"></event></eventGroup><numberingGroup><numbering type="pageFirst" number="1240">1240</numbering><numbering type="pageLast" number="1246">1246</numbering></numberingGroup><correspondenceTo>
J.P. Ortonne. <b>E‐mail:</b><email>ortonne@unice.fr</email></correspondenceTo><linkGroup><link type="toTypesetVersion" href="file:JDV.JDV4269.pdf"></link></linkGroup></publicationMeta><contentMeta><unparsedEditorialHistory>Received: 25 January 2011; Accepted: 25 August 2011</unparsedEditorialHistory><countGroup><count type="figureTotal" number="5"></count><count type="tableTotal" number="0"></count></countGroup><titleGroup><title type="main">Evaluation of the efficacy and safety of a CS20<sup>®</sup> protective barrier gel containing OGT compared with topical aciclovir and placebo on functional and objective symptoms of labial herpes recurrences: a randomized clinical trial</title><title type="shortAuthors">Khemis <i>et al.</i></title><title type="short">Efficacy and safety of OGT protective barrier gel in labial herpes</title></titleGroup><creators><creator creatorRole="author" xml:id="cr1" affiliationRef="#a1"><personName><givenNames>A.</givenNames><familyName>Khemis</familyName></personName></creator><creator creatorRole="author" xml:id="cr2" affiliationRef="#a1"><personName><givenNames>L.</givenNames><familyName>Duteil</familyName></personName></creator><creator creatorRole="author" xml:id="cr3" affiliationRef="#a2"><personName><givenNames>A.C.</givenNames><familyName>Coudert</familyName></personName></creator><creator creatorRole="author" xml:id="cr4" affiliationRef="#a3"><personName><givenNames>Y.</givenNames><familyName>Tillet</familyName></personName></creator><creator creatorRole="author" xml:id="cr5" affiliationRef="#a4"><personName><givenNames>O.</givenNames><familyName>Dereure</familyName></personName></creator><creator creatorRole="author" xml:id="cr6" affiliationRef="#a1" corresponding="yes"><personName><givenNames>J.P.</givenNames><familyName>Ortonne</familyName></personName></creator></creators><affiliationGroup><affiliation xml:id="a1" countryCode="FR"><unparsedAffiliation>Service de Dermatologie, Hôpital L’Archet 2, 151, route de Saint Antoine de Ginestière, 06202 Nice Cedex 3, France</unparsedAffiliation></affiliation><affiliation xml:id="a2" countryCode="FR"><unparsedAffiliation>Laboratoires Carilène, 7, rue du Chant des Oiseaux, 78360 Montesson, France</unparsedAffiliation></affiliation><affiliation xml:id="a3" countryCode="FR"><unparsedAffiliation>White‐Tillet Consultants & Experts 35, rue Franck Hémon, 77500 Chelles, France</unparsedAffiliation></affiliation><affiliation xml:id="a4" countryCode="FR"><unparsedAffiliation>Service de Dermatologie, Hôpital Saint‐Eloi, 80 avenue A Fliche, 34295 Montpellier Cedex 5, France</unparsedAffiliation></affiliation></affiliationGroup><abstractGroup><abstract type="main" xml:lang="en"><title type="main">Abstract</title><p><b>Background </b> Topical or systemic antiviral drugs reduce the duration of herpes simplex virus 1 (HSV‐1) recurrences but may not alleviate functional symptoms.</p><p><b>Objectives </b> To assess the efficacy and safety of CS20 (Acura 24<sup>®</sup>) protective barrier gel versus topical aciclovir and placebo in resolving functional symptoms in HSV‐1 labial recurrences.</p><p><b>Methods </b> A prospective, randomized, single‐centre, assessor‐blinded study of CS20 versus topical aciclovir or placebo. The primary endpoint was the total score of four herpes‐related functional symptoms (pain, burning, itching, and tingling sensations), evaluated by visual analogue scale (VAS). Secondary endpoints encompassed objective skin changes (oedema, crusting and erythema), evaluated by specific clinical scores.</p><p><b>Results </b> In a study of 106 patients, compared with placebo, a significant improvement in total functional symptom score was observed after 1 day of treatment in the CS20 group, but only after 7 days of treatment in the topical aciclovir group. Burning sensations were significantly reduced by CS20 compared with aciclovir (Days 1–2) or placebo (Days 1–7). Compared to placebo, CS20 significantly reduced pain intensity on Days 1–6. CS20 induced significant and early improvements in the clinical scores for oedema and crusting compared with placebo. Time to cure was similar for CS20 and aciclovir. The treatments were well tolerated and adverse events were comparable in the three treatment groups.</p><p><b>Limitations </b> The single‐centre and single‐blind design of the study and the preselection of patients.</p><p><b>Conclusion </b> CS20 showed superior effectiveness against functional symptoms (pain and burning) associated with HSV‐1 labial recurrences and was similar to aciclovir for time to cure.</p></abstract></abstractGroup></contentMeta><noteGroup><note xml:id="fn1"><p>Conflict of interest
A Khemis: no conflict of interest to disclose.</p><p>L Duteil: no conflict of interest to disclose.</p><p>AC Coudert: no conflict of interest to disclose. Laboratoires Carilène’s employee as Pharmacist, Regulatory and Quality Assurance Director.</p><p>Y Tillet: Laboratoires Carilène’s Consultant who contributed to the development of the study protocol and scientific publication.</p><p>O Dereure: He has been a consultant for Laboratoires Carilène and contributed to the scientific publication.</p><p>JP Ortonne: no conflict of interest to disclose.</p></note></noteGroup></header></component></istex:document></istex:metadataXml><mods version="3.6"><titleInfo lang="en"><title>Evaluation of the efficacy and safety of a CS20® protective barrier gel containing OGT compared with topical aciclovir and placebo on functional and objective symptoms of labial herpes recurrences: a randomized clinical trial</title></titleInfo><titleInfo type="abbreviated" lang="en"><title>Efficacy and safety of OGT protective barrier gel in labial herpes</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>Evaluation of the efficacy and safety of a CS20® protective barrier gel containing OGT compared with topical aciclovir and placebo on functional and objective symptoms of labial herpes recurrences: a randomized clinical trial</title></titleInfo><name type="personal"><namePart type="given">A.</namePart><namePart type="family">Khemis</namePart><affiliation>Service de Dermatologie, Hôpital L’Archet 2, 151, route de Saint Antoine de Ginestière, 06202 Nice Cedex 3, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">L.</namePart><namePart type="family">Duteil</namePart><affiliation>Service de Dermatologie, Hôpital L’Archet 2, 151, route de Saint Antoine de Ginestière, 06202 Nice Cedex 3, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">A.C.</namePart><namePart type="family">Coudert</namePart><affiliation>Laboratoires Carilène, 7, rue du Chant des Oiseaux, 78360 Montesson, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Y.</namePart><namePart type="family">Tillet</namePart><affiliation>White‐Tillet Consultants & Experts 35, rue Franck Hémon, 77500 Chelles, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">O.</namePart><namePart type="family">Dereure</namePart><affiliation>Service de Dermatologie, Hôpital Saint‐Eloi, 80 avenue A Fliche, 34295 Montpellier Cedex 5, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">J.P.</namePart><namePart type="family">Ortonne</namePart><affiliation>Service de Dermatologie, Hôpital L’Archet 2, 151, route de Saint Antoine de Ginestière, 06202 Nice Cedex 3, France</affiliation><affiliation>E-mail: ortonne@unice.fr</affiliation><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="article" displayLabel="article" authority="ISTEX" authorityURI="https://content-type.data.istex.fr" valueURI="https://content-type.data.istex.fr/ark:/67375/XTP-6N5SZHKN-D">article</genre><originInfo><publisher>Blackwell Publishing Ltd</publisher><place><placeTerm type="text">Oxford, UK</placeTerm></place><dateIssued encoding="w3cdtf">2012-10</dateIssued><edition>Received: 25 January 2011; Accepted: 25 August 2011</edition><copyrightDate encoding="w3cdtf">2012</copyrightDate></originInfo><language><languageTerm type="code" authority="rfc3066">en</languageTerm><languageTerm type="code" authority="iso639-2b">eng</languageTerm></language><physicalDescription><extent unit="figures">5</extent><extent unit="tables">0</extent></physicalDescription><abstract>Background Topical or systemic antiviral drugs reduce the duration of herpes simplex virus 1 (HSV‐1) recurrences but may not alleviate functional symptoms.</abstract><abstract>Objectives To assess the efficacy and safety of CS20 (Acura 24®) protective barrier gel versus topical aciclovir and placebo in resolving functional symptoms in HSV‐1 labial recurrences.</abstract><abstract>Methods A prospective, randomized, single‐centre, assessor‐blinded study of CS20 versus topical aciclovir or placebo. The primary endpoint was the total score of four herpes‐related functional symptoms (pain, burning, itching, and tingling sensations), evaluated by visual analogue scale (VAS). Secondary endpoints encompassed objective skin changes (oedema, crusting and erythema), evaluated by specific clinical scores.</abstract><abstract>Results In a study of 106 patients, compared with placebo, a significant improvement in total functional symptom score was observed after 1 day of treatment in the CS20 group, but only after 7 days of treatment in the topical aciclovir group. Burning sensations were significantly reduced by CS20 compared with aciclovir (Days 1–2) or placebo (Days 1–7). Compared to placebo, CS20 significantly reduced pain intensity on Days 1–6. CS20 induced significant and early improvements in the clinical scores for oedema and crusting compared with placebo. Time to cure was similar for CS20 and aciclovir. The treatments were well tolerated and adverse events were comparable in the three treatment groups.</abstract><abstract>Limitations The single‐centre and single‐blind design of the study and the preselection of patients.</abstract><abstract>Conclusion CS20 showed superior effectiveness against functional symptoms (pain and burning) associated with HSV‐1 labial recurrences and was similar to aciclovir for time to cure.</abstract><relatedItem type="host"><titleInfo><title>Journal of the European Academy of Dermatology and Venereology</title></titleInfo><genre type="journal" authority="ISTEX" authorityURI="https://publication-type.data.istex.fr" valueURI="https://publication-type.data.istex.fr/ark:/67375/JMC-0GLKJH51-B">journal</genre><subject><genre>article-category</genre><topic>ORIGINAL ARTICLE</topic></subject><identifier type="ISSN">0926-9959</identifier><identifier type="eISSN">1468-3083</identifier><identifier type="DOI">10.1111/(ISSN)1468-3083</identifier><identifier type="PublisherID">JDV</identifier><part><date>2012</date><detail type="volume"><caption>vol.</caption><number>26</number></detail><detail type="issue"><caption>no.</caption><number>10</number></detail><extent unit="pages"><start>1240</start><end>1246</end><total>7</total></extent></part></relatedItem><identifier type="istex">1450E6DD7D7326D61875E2B7F534873A886626BC</identifier><identifier type="ark">ark:/67375/WNG-VR2Q5HQ1-7</identifier><identifier type="DOI">10.1111/j.1468-3083.2011.04269.x</identifier><identifier type="ArticleID">JDV4269</identifier><accessCondition type="use and reproduction" contentType="copyright">© 2011 The Authors. 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