Daylight photodynamic therapy with methyl aminolevulinate cream as a convenient, similarly effective, nearly painless alternative to conventional photodynamic therapy in actinic keratosis treatment: a randomized controlled trial
Identifieur interne : 001E37 ( Istex/Corpus ); précédent : 001E36; suivant : 001E38Daylight photodynamic therapy with methyl aminolevulinate cream as a convenient, similarly effective, nearly painless alternative to conventional photodynamic therapy in actinic keratosis treatment: a randomized controlled trial
Auteurs : D. M. Rubel ; L. Spelman ; D. F. Murrell ; J. See ; D. Hewitt ; P. Foley ; C. Bosc ; D. Kerob ; N. Kerrouche ; H. C. Wulf ; S. ShumackSource :
- British Journal of Dermatology [ 0007-0963 ] ; 2014-11.
Abstract
Daylight photodynamic therapy (DL‐PDT) of actinic keratosis (AK) has shown preliminary efficacy and safety results comparable to conventional photodynamic therapy (c‐PDT), using methyl aminolevulinate (MAL) cream.
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DOI: 10.1111/bjd.13138
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Rubel</name><affiliation><mods:affiliation>Woden Dermatology and Probity Medical Research, Level 1, 1 Bowes Place, 2606, Phillip, ACT, Australia</mods:affiliation></affiliation><affiliation><mods:affiliation>Australian National University, Canberra, Australia</mods:affiliation></affiliation><affiliation><mods:affiliation>.:</mods:affiliation></affiliation><affiliation><mods:affiliation>E-mail: diana@wodendermatology.com.au</mods:affiliation></affiliation></author><author><name sortKey="Spelman, L" sort="Spelman, L" uniqKey="Spelman L" first="L." last="Spelman">L. Spelman</name><affiliation><mods:affiliation>Specialist Connect, Qld, Woolloongabba, Australia</mods:affiliation></affiliation></author><author><name sortKey="Murrell, D F" sort="Murrell, D F" uniqKey="Murrell D" first="D. F." last="Murrell">D. F. Murrell</name><affiliation><mods:affiliation>Premier Specialists, KogarahSydney, NSW, Australia</mods:affiliation></affiliation><affiliation><mods:affiliation>University of NSW, NSW, Sydney, Australia</mods:affiliation></affiliation></author><author><name sortKey="See, J" sort="See, J" uniqKey="See J" first="J." last="See">J. See</name><affiliation><mods:affiliation>Central Sydney Dermatology, NSW, Sydney, Australia</mods:affiliation></affiliation></author><author><name sortKey="Hewitt, D" sort="Hewitt, D" uniqKey="Hewitt D" first="D." last="Hewitt">D. Hewitt</name><affiliation><mods:affiliation>Skin and Cancer Foundation, NSW, Westmead, Australia</mods:affiliation></affiliation></author><author><name sortKey="Foley, P" sort="Foley, P" uniqKey="Foley P" first="P." last="Foley">P. Foley</name><affiliation><mods:affiliation>Skin and Cancer Foundation Inc., Carlton, Vic., Australia</mods:affiliation></affiliation><affiliation><mods:affiliation>The University of Melbourne, Parkville, Vic., Australia</mods:affiliation></affiliation><affiliation><mods:affiliation>St Vincent's Hospital, Vic., FitzroyMelbourne, Australia</mods:affiliation></affiliation></author><author><name sortKey="Bosc, C" sort="Bosc, C" uniqKey="Bosc C" first="C." last="Bosc">C. Bosc</name><affiliation><mods:affiliation>Galderma R&D, Sophia Antipolis, France</mods:affiliation></affiliation></author><author><name sortKey="Kerob, D" sort="Kerob, D" uniqKey="Kerob D" first="D." last="Kerob">D. Kerob</name><affiliation><mods:affiliation>Galderma International, Paris, France</mods:affiliation></affiliation></author><author><name sortKey="Kerrouche, N" sort="Kerrouche, N" uniqKey="Kerrouche N" first="N." last="Kerrouche">N. Kerrouche</name><affiliation><mods:affiliation>Galderma R&D, Sophia Antipolis, France</mods:affiliation></affiliation></author><author><name sortKey="Wulf, H C" sort="Wulf, H C" uniqKey="Wulf H" first="H. C." last="Wulf">H. C. Wulf</name><affiliation><mods:affiliation>Bispebjerg Hospital, Copenhagen University, Copenhagen, Denmark</mods:affiliation></affiliation></author><author><name sortKey="Shumack, S" sort="Shumack, S" uniqKey="Shumack S" first="S." last="Shumack">S. 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M." last="Rubel">D. M. Rubel</name><affiliation><mods:affiliation>Woden Dermatology and Probity Medical Research, Level 1, 1 Bowes Place, 2606, Phillip, ACT, Australia</mods:affiliation></affiliation><affiliation><mods:affiliation>Australian National University, Canberra, Australia</mods:affiliation></affiliation><affiliation><mods:affiliation>.:</mods:affiliation></affiliation><affiliation><mods:affiliation>E-mail: diana@wodendermatology.com.au</mods:affiliation></affiliation></author><author><name sortKey="Spelman, L" sort="Spelman, L" uniqKey="Spelman L" first="L." last="Spelman">L. Spelman</name><affiliation><mods:affiliation>Specialist Connect, Qld, Woolloongabba, Australia</mods:affiliation></affiliation></author><author><name sortKey="Murrell, D F" sort="Murrell, D F" uniqKey="Murrell D" first="D. F." last="Murrell">D. F. Murrell</name><affiliation><mods:affiliation>Premier Specialists, KogarahSydney, NSW, Australia</mods:affiliation></affiliation><affiliation><mods:affiliation>University of NSW, NSW, Sydney, Australia</mods:affiliation></affiliation></author><author><name sortKey="See, J" sort="See, J" uniqKey="See J" first="J." last="See">J. See</name><affiliation><mods:affiliation>Central Sydney Dermatology, NSW, Sydney, Australia</mods:affiliation></affiliation></author><author><name sortKey="Hewitt, D" sort="Hewitt, D" uniqKey="Hewitt D" first="D." last="Hewitt">D. Hewitt</name><affiliation><mods:affiliation>Skin and Cancer Foundation, NSW, Westmead, Australia</mods:affiliation></affiliation></author><author><name sortKey="Foley, P" sort="Foley, P" uniqKey="Foley P" first="P." last="Foley">P. Foley</name><affiliation><mods:affiliation>Skin and Cancer Foundation Inc., Carlton, Vic., Australia</mods:affiliation></affiliation><affiliation><mods:affiliation>The University of Melbourne, Parkville, Vic., Australia</mods:affiliation></affiliation><affiliation><mods:affiliation>St Vincent's Hospital, Vic., FitzroyMelbourne, Australia</mods:affiliation></affiliation></author><author><name sortKey="Bosc, C" sort="Bosc, C" uniqKey="Bosc C" first="C." last="Bosc">C. Bosc</name><affiliation><mods:affiliation>Galderma R&D, Sophia Antipolis, France</mods:affiliation></affiliation></author><author><name sortKey="Kerob, D" sort="Kerob, D" uniqKey="Kerob D" first="D." last="Kerob">D. Kerob</name><affiliation><mods:affiliation>Galderma International, Paris, France</mods:affiliation></affiliation></author><author><name sortKey="Kerrouche, N" sort="Kerrouche, N" uniqKey="Kerrouche N" first="N." last="Kerrouche">N. 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Shumack</name><affiliation><mods:affiliation>St George Dermatology and Skin Cancer Centre and Probity Medical Research, Kogarah, NSW, Sydney, Australia</mods:affiliation></affiliation></author></analytic><monogr></monogr><series><title level="j" type="main">British Journal of Dermatology</title><title level="j" type="alt">BRITISH JOURNAL OF DERMATOLOGY</title><idno type="ISSN">0007-0963</idno><idno type="eISSN">1365-2133</idno><imprint><biblScope unit="vol">171</biblScope><biblScope unit="issue">5</biblScope><biblScope unit="page" from="1164">1164</biblScope><biblScope unit="page" to="1171">1171</biblScope><biblScope unit="page-count">8</biblScope><date type="published" when="2014-11">2014-11</date></imprint><idno type="ISSN">0007-0963</idno></series></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0007-0963</idno></seriesStmt></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract">Daylight photodynamic therapy (DL‐PDT) of actinic keratosis (AK) has shown preliminary efficacy and safety results comparable to conventional photodynamic therapy (c‐PDT), using methyl aminolevulinate (MAL) cream.</div></front></TEI><istex><corpusName>wiley</corpusName><author><json:item><name>D.M. 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Hewitt</name><affiliations><json:string>Skin and Cancer Foundation, NSW, Westmead, Australia</json:string></affiliations></json:item><json:item><name>P. Foley</name><affiliations><json:string>Skin and Cancer Foundation Inc., Carlton, Vic., Australia</json:string><json:string>The University of Melbourne, Parkville, Vic., Australia</json:string><json:string>St Vincent's Hospital, Vic., FitzroyMelbourne, Australia</json:string></affiliations></json:item><json:item><name>C. Bosc</name><affiliations><json:string>Galderma R&D, Sophia Antipolis, France</json:string></affiliations></json:item><json:item><name>D. Kerob</name><affiliations><json:string>Galderma International, Paris, France</json:string></affiliations></json:item><json:item><name>N. Kerrouche</name><affiliations><json:string>Galderma R&D, Sophia Antipolis, France</json:string></affiliations></json:item><json:item><name>H.C. Wulf</name><affiliations><json:string>Bispebjerg Hospital, Copenhagen University, Copenhagen, Denmark</json:string></affiliations></json:item><json:item><name>S. 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Rubel. E‐mail: diana@wodendermatology.com.au</affiliation></author><author xml:id="author-0001"><persName><forename type="first">L.</forename><surname>Spelman</surname></persName><affiliation><orgName>Specialist Connect</orgName><address><settlement type="city">Woolloongabba</settlement><region>Qld</region><country key="AU">Australia</country></address></affiliation></author><author xml:id="author-0002"><persName><forename type="first">D.F.</forename><surname>Murrell</surname></persName><affiliation><orgName>Premier Specialists</orgName><address><settlement type="city">KogarahSydney</settlement><region>NSW</region><country key="AU">Australia</country></address></affiliation><affiliation><orgName>University of NSW</orgName><address><settlement type="city">Sydney</settlement><region>NSW</region><country key="AU">Australia</country></address></affiliation></author><author xml:id="author-0003"><persName><forename type="first">J.‐A.</forename><surname>See</surname></persName><affiliation><orgName>Central Sydney Dermatology</orgName><address><settlement type="city">Sydney</settlement><region>NSW</region><country key="AU">Australia</country></address></affiliation></author><author xml:id="author-0004"><persName><forename type="first">D.</forename><surname>Hewitt</surname></persName><affiliation><orgName>Skin and Cancer Foundation</orgName><address><settlement type="city">Westmead</settlement><region>NSW</region><country key="AU">Australia</country></address></affiliation></author><author xml:id="author-0005"><persName><forename type="first">P.</forename><surname>Foley</surname></persName><affiliation><orgName>Skin and Cancer Foundation Inc.</orgName><address><settlement type="city">Carlton</settlement><region>Vic.</region><country key="AU">Australia</country></address></affiliation><affiliation><orgName>The University of Melbourne</orgName><address><settlement type="city">Parkville</settlement><region>Vic.</region><country key="AU">Australia</country></address></affiliation><affiliation><orgName>St Vincent's Hospital</orgName><address><settlement type="city">FitzroyMelbourne</settlement><region>Vic.</region><country key="AU">Australia</country></address></affiliation></author><author xml:id="author-0006"><persName><forename type="first">C.</forename><surname>Bosc</surname></persName><affiliation><orgName>Galderma R&D</orgName><orgName>Sophia Antipolis</orgName><address><country key="FR">France</country></address></affiliation></author><author xml:id="author-0007"><persName><forename type="first">D.</forename><surname>Kerob</surname></persName><affiliation><orgName>Galderma International</orgName><address><settlement type="city">Paris</settlement><country key="FR">France</country></address></affiliation></author><author xml:id="author-0008"><persName><forename type="first">N.</forename><surname>Kerrouche</surname></persName><affiliation><orgName>Galderma R&D</orgName><orgName>Sophia Antipolis</orgName><address><country key="FR">France</country></address></affiliation></author><author xml:id="author-0009"><persName><forename type="first">H.C.</forename><surname>Wulf</surname></persName><affiliation><orgName>Bispebjerg Hospital</orgName><orgName>Copenhagen University</orgName><address><settlement type="city">Copenhagen</settlement><country key="DK">Denmark</country></address></affiliation></author><author xml:id="author-0010"><persName><forename type="first">S.</forename><surname>Shumack</surname></persName><affiliation><orgName>St George Dermatology and Skin Cancer Centre and Probity Medical Research</orgName><address><street>Kogarah</street><settlement type="city">Sydney</settlement><region>NSW</region><country key="AU">Australia</country></address></affiliation></author><idno type="istex">A07243A6DDCC5B26542FD1C68AAB9345B287AD28</idno><idno type="ark">ark:/67375/WNG-5BKVL18V-4</idno><idno type="DOI">10.1111/bjd.13138</idno><idno type="unit">BJD13138</idno><idno type="toTypesetVersion">file:BJD.BJD13138.pdf</idno></analytic><monogr><title level="j" type="main">British Journal of Dermatology</title><title level="j" type="alt">BRITISH JOURNAL OF DERMATOLOGY</title><idno type="pISSN">0007-0963</idno><idno type="eISSN">1365-2133</idno><idno type="book-DOI">10.1111/(ISSN)1365-2133</idno><idno type="book-part-DOI">10.1111/bjd.2014.171.issue-5</idno><idno type="product">BJD</idno><imprint><biblScope unit="vol">171</biblScope><biblScope unit="issue">5</biblScope><biblScope unit="page" from="1164">1164</biblScope><biblScope unit="page" to="1171">1171</biblScope><biblScope unit="page-count">8</biblScope><date type="published" when="2014-11"></date></imprint></monogr></biblStruct></sourceDesc></fileDesc><profileDesc><abstract style="main" xml:id="bjd13138-abs-0001"><head>Summary</head>
Background
<p>Daylight photodynamic therapy (<hi rend="fc">DL</hi>‐<hi rend="fc">PDT</hi>) of actinic keratosis (<hi rend="fc">AK</hi>) has shown preliminary efficacy and safety results comparable to conventional photodynamic therapy (c‐<hi rend="fc">PDT</hi>), using methyl aminolevulinate (<hi rend="fc">MAL</hi>) cream.</p>
Objectives
<p>To demonstrate the efficacy and safety of <hi rend="fc">DL</hi>‐<hi rend="fc">PDT</hi> vs. c‐<hi rend="fc">PDT</hi> in treating mild facial/scalp <hi rend="fc">AK</hi>.</p>
Materials and methods
<p>This 24‐week randomized, controlled, investigator‐blinded, multicentre, intra‐individual efficacy (non‐inferiority) and safety (superiority regarding pain) study enrolled 100 subjects. <hi rend="fc">AK</hi>s on the face/scalp were treated once, with <hi rend="fc">DL</hi>‐<hi rend="fc">PDT</hi> on one side and c‐<hi rend="fc">PDT</hi> on the contralateral side. Primary end points for <hi rend="fc">DL</hi>‐<hi rend="fc">PDT</hi> at week 12 were efficacy [non‐inferiority regarding complete lesion response (mild <hi rend="fc">AK</hi>)] and safety (superiority regarding subject's assessment of pain). Lesions with complete response 12 weeks after one treatment session were followed until week 24. The safety evaluation included incidence of adverse events. Subject satisfaction was classified using a questionnaire.</p>
Results
<p>At week 12, the complete lesion response rate with <hi rend="fc">DL</hi>‐<hi rend="fc">PDT</hi> was non‐inferior to c‐<hi rend="fc">PDT</hi> (89·2% vs. 92·8%, respectively; 95% confidence interval −6·8 to −0·3), confirmed by intention‐to‐treat analysis. Additionally, regardless of the treatment used, 96% of mild lesions were maintained in complete response 24 weeks after the <hi rend="fc">PDT</hi> session. For <hi rend="fc">DL</hi>‐<hi rend="fc">PDT</hi>, subject‐reported pain was significantly lower (0·8 vs. 5·7, respectively; <hi rend="italic">P </hi><<hi rend="italic"> </hi>0·001), with better tolerability and significantly higher subject satisfaction regarding convenience and outcome.</p>
Conclusions
<p>Daylight‐mediated <hi rend="fc">PDT</hi> was not inferior in efficacy to <hi rend="fc">M</hi>etvix c‐<hi rend="fc">PDT</hi> (mild <hi rend="fc">AK</hi> response rate), better tolerated, nearly painless and more convenient for patients.</p></abstract><abstract style="short" xml:id="bjd13138-abs-0002"><p><hi rend="bold">What's already known about this topic?</hi></p><p><list xml:id="bjd13138-list-0001" style="bulleted"><item>Methyl aminolevulinate conventional photodynamic therapy (<hi rend="fc">MAL</hi> c‐<hi rend="fc">PDT</hi>) is effective for treating actinic keratosis (<hi rend="fc">AK</hi>), but may be a painful, inconvenient procedure. Daylight <hi rend="fc">PDT</hi> (<hi rend="fc">DL</hi>‐<hi rend="fc">PDT</hi>) has shown good efficacy and safety results compared with c‐<hi rend="fc">PDT</hi> in a previous randomized, controlled, exploratory trial.</item></list></p><p><hi rend="bold">What does this study add?</hi></p><p><list xml:id="bjd13138-list-0002" style="bulleted"><item>This study confirms previous findings that <hi rend="fc">DL</hi>‐<hi rend="fc">PDT</hi> can be considered as an effective, safe and convenient alternative for the treatment of facial/scalp <hi rend="fc">AK</hi>.</item><item>This is the first study showing a high maintenance of complete lesion response 6 months after one treatment.</item></list></p></abstract><textClass><keywords rend="articleCategory"><term>Photobiology</term></keywords><keywords rend="tocHeading1"><term>Original articles</term></keywords><keywords rend="tocHeading2"><term>Photobiology</term></keywords></textClass><langUsage><language ident="en"></language></langUsage></profileDesc></teiHeader></istex:fulltextTEI></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 type="serialArticle" version="2.0" xml:id="bjd13138" xml:lang="en"><header><publicationMeta level="product"><doi origin="wiley" registered="yes">10.1111/(ISSN)1365-2133</doi><issn type="print">0007-0963</issn><issn type="electronic">1365-2133</issn><idGroup><id type="product" value="BJD"></id></idGroup><titleGroup><title sort="BRITISH JOURNAL OF DERMATOLOGY" type="main">British Journal of Dermatology</title><title type="short">Br J Dermatol</title></titleGroup></publicationMeta><publicationMeta level="part" position="50"><doi origin="wiley">10.1111/bjd.2014.171.issue-5</doi><copyright ownership="thirdParty">Copyright © 2014 British Association of Dermatologists</copyright><numberingGroup><numbering type="journalVolume" number="171">171</numbering><numbering type="journalIssue">5</numbering></numberingGroup><coverDate startDate="2014-11">November 2014</coverDate></publicationMeta><publicationMeta level="unit" position="400" status="forIssue" type="article"><doi>10.1111/bjd.13138</doi><idGroup><id type="unit" value="BJD13138"></id></idGroup><countGroup><count number="8" type="pageTotal"></count></countGroup><titleGroup><title type="articleCategory">Photobiology</title><title type="tocHeading1">Original articles</title><title type="tocHeading2">Photobiology</title></titleGroup><copyright ownership="thirdParty">© 2014 British Association of Dermatologists</copyright><eventGroup><event date="2014-05-20" type="manuscriptAccepted"></event><event agent="SPS" date="2014-08-08" type="xmlCreated"></event><event type="publishedOnlineAccepted" date="2014-05-24"></event><event type="publishedOnlineEarlyUnpaginated" date="2014-10-20"></event><event type="firstOnline" date="2014-10-20"></event><event type="publishedOnlineFinalForm" date="2014-11-19"></event><event type="xmlConverted" agent="Converter:WML3G_To_WML3G version:4.6.4 mode:FullText" date="2015-10-06"></event></eventGroup><numberingGroup><numbering type="pageFirst">1164</numbering><numbering type="pageLast">1171</numbering></numberingGroup><correspondenceTo><lineatedText><line><b>Correspondence</b></line><line><i>Diana M. Rubel</i>.</line><line><i>E‐mail</i>: <email>diana@wodendermatology.com.au</email></line></lineatedText></correspondenceTo><linkGroup><link type="toTypesetVersion" href="file:BJD.BJD13138.pdf"></link></linkGroup></publicationMeta><contentMeta><titleGroup><title type="main">Daylight photodynamic therapy with methyl aminolevulinate cream as a convenient, similarly effective, nearly painless alternative to conventional photodynamic therapy in actinic keratosis treatment: a randomized controlled trial</title><title type="shortAuthors">D.M. Rubel <i>et al</i>.</title></titleGroup><creators><creator affiliationRef="#bjd13138-aff-0001 #bjd13138-aff-0002" corresponding="yes" creatorRole="author" xml:id="bjd13138-cr-0001"><personName><givenNames>D.M.</givenNames> <familyName>Rubel</familyName></personName></creator><creator affiliationRef="#bjd13138-aff-0003" creatorRole="author" xml:id="bjd13138-cr-0002"><personName><givenNames>L.</givenNames> <familyName>Spelman</familyName></personName></creator><creator affiliationRef="#bjd13138-aff-0004 #bjd13138-aff-0005" creatorRole="author" xml:id="bjd13138-cr-0003"><personName><givenNames>D.F.</givenNames> <familyName>Murrell</familyName></personName></creator><creator affiliationRef="#bjd13138-aff-0006" creatorRole="author" xml:id="bjd13138-cr-0004"><personName><givenNames>J.‐A.</givenNames> <familyName>See</familyName></personName></creator><creator affiliationRef="#bjd13138-aff-0007" creatorRole="author" xml:id="bjd13138-cr-0005"><personName><givenNames>D.</givenNames> <familyName>Hewitt</familyName></personName></creator><creator affiliationRef="#bjd13138-aff-0008 #bjd13138-aff-0009 #bjd13138-aff-0010" creatorRole="author" xml:id="bjd13138-cr-0006"><personName><givenNames>P.</givenNames> <familyName>Foley</familyName></personName></creator><creator affiliationRef="#bjd13138-aff-0011" creatorRole="author" xml:id="bjd13138-cr-0011"><personName><givenNames>C.</givenNames> <familyName>Bosc</familyName></personName></creator><creator affiliationRef="#bjd13138-aff-0012" creatorRole="author" xml:id="bjd13138-cr-0007"><personName><givenNames>D.</givenNames> <familyName>Kerob</familyName></personName></creator><creator affiliationRef="#bjd13138-aff-0011" creatorRole="author" xml:id="bjd13138-cr-0008"><personName><givenNames>N.</givenNames> <familyName>Kerrouche</familyName></personName></creator><creator affiliationRef="#bjd13138-aff-0013" creatorRole="author" xml:id="bjd13138-cr-0009"><personName><givenNames>H.C.</givenNames> <familyName>Wulf</familyName></personName></creator><creator affiliationRef="#bjd13138-aff-0014" creatorRole="author" xml:id="bjd13138-cr-0010"><personName><givenNames>S.</givenNames> <familyName>Shumack</familyName></personName></creator></creators><affiliationGroup><affiliation countryCode="AU" type="organization" xml:id="bjd13138-aff-0001"><orgName>Woden Dermatology and Probity Medical Research</orgName> <address><street>Level 1, 1 Bowes Place</street> <city>Phillip</city> <countryPart>ACT</countryPart> <postCode>2606</postCode> <country>Australia</country></address></affiliation><affiliation countryCode="AU" type="organization" xml:id="bjd13138-aff-0002"><orgName>Australian National University</orgName> <address><city>Canberra</city> <country>Australia</country></address></affiliation><affiliation countryCode="AU" type="organization" xml:id="bjd13138-aff-0003"><orgName>Specialist Connect</orgName> <address><city>Woolloongabba</city> <countryPart>Qld</countryPart> <country>Australia</country></address></affiliation><affiliation countryCode="AU" type="organization" xml:id="bjd13138-aff-0004"><orgName>Premier Specialists</orgName> <address><city>Kogarah</city> <city>Sydney</city> <countryPart>NSW</countryPart> <country>Australia</country></address></affiliation><affiliation countryCode="AU" type="organization" xml:id="bjd13138-aff-0005"><orgName>University of NSW</orgName> <address><city>Sydney</city> <countryPart>NSW</countryPart> <country>Australia</country></address></affiliation><affiliation countryCode="AU" type="organization" xml:id="bjd13138-aff-0006"><orgName>Central Sydney Dermatology</orgName> <address><city>Sydney</city> <countryPart>NSW</countryPart> <country>Australia</country></address></affiliation><affiliation countryCode="AU" type="organization" xml:id="bjd13138-aff-0007"><orgName>Skin and Cancer Foundation</orgName> <address><city>Westmead</city> <countryPart>NSW</countryPart> <country>Australia</country></address></affiliation><affiliation countryCode="AU" type="organization" xml:id="bjd13138-aff-0008"><orgName>Skin and Cancer Foundation Inc.</orgName> <address><city>Carlton</city> <countryPart>Vic.</countryPart> <country>Australia</country></address></affiliation><affiliation countryCode="AU" type="organization" xml:id="bjd13138-aff-0009"><orgName>The University of Melbourne</orgName> <address><city>Parkville</city> <countryPart>Vic.</countryPart> <country>Australia</country></address></affiliation><affiliation countryCode="AU" type="organization" xml:id="bjd13138-aff-0010"><orgName>St Vincent's Hospital</orgName> <address><city>Fitzroy</city> <city>Melbourne</city> <countryPart>Vic.</countryPart> <country>Australia</country></address></affiliation><affiliation countryCode="FR" type="organization" xml:id="bjd13138-aff-0011"><orgName>Galderma R&D</orgName> <orgName>Sophia Antipolis</orgName> <address><country>France</country></address></affiliation><affiliation countryCode="FR" type="organization" xml:id="bjd13138-aff-0012"><orgName>Galderma International</orgName> <address><city>Paris</city> <country>France</country></address></affiliation><affiliation countryCode="DK" type="organization" xml:id="bjd13138-aff-0013"><orgDiv>Bispebjerg Hospital</orgDiv> <orgName>Copenhagen University</orgName> <address><city>Copenhagen</city> <country>Denmark</country></address></affiliation><affiliation countryCode="AU" type="organization" xml:id="bjd13138-aff-0014"><orgName>St George Dermatology and Skin Cancer Centre and Probity Medical Research</orgName> <address><street>Kogarah</street> <city>Sydney</city> <countryPart>NSW</countryPart> <country>Australia</country></address></affiliation></affiliationGroup><fundingInfo><fundingAgency>Galderma R&D</fundingAgency></fundingInfo><abstractGroup><abstract type="main" xml:id="bjd13138-abs-0001"><title type="main">Summary</title><section xml:id="bjd13138-sec-0001"><title type="main">Background</title><p>Daylight photodynamic therapy (<fc>DL</fc>‐<fc>PDT</fc>) of actinic keratosis (<fc>AK</fc>) has shown preliminary efficacy and safety results comparable to conventional photodynamic therapy (c‐<fc>PDT</fc>), using methyl aminolevulinate (<fc>MAL</fc>) cream.</p></section><section xml:id="bjd13138-sec-0002"><title type="main">Objectives</title><p>To demonstrate the efficacy and safety of <fc>DL</fc>‐<fc>PDT</fc> vs. c‐<fc>PDT</fc> in treating mild facial/scalp <fc>AK</fc>.</p></section><section xml:id="bjd13138-sec-0003"><title type="main">Materials and methods</title><p>This 24‐week randomized, controlled, investigator‐blinded, multicentre, intra‐individual efficacy (non‐inferiority) and safety (superiority regarding pain) study enrolled 100 subjects. <fc>AK</fc>s on the face/scalp were treated once, with <fc>DL</fc>‐<fc>PDT</fc> on one side and c‐<fc>PDT</fc> on the contralateral side. Primary end points for <fc>DL</fc>‐<fc>PDT</fc> at week 12 were efficacy [non‐inferiority regarding complete lesion response (mild <fc>AK</fc>)] and safety (superiority regarding subject's assessment of pain). Lesions with complete response 12 weeks after one treatment session were followed until week 24. The safety evaluation included incidence of adverse events. Subject satisfaction was classified using a questionnaire.</p></section><section xml:id="bjd13138-sec-0004"><title type="main">Results</title><p>At week 12, the complete lesion response rate with <fc>DL</fc>‐<fc>PDT</fc> was non‐inferior to c‐<fc>PDT</fc> (89·2% vs. 92·8%, respectively; 95% confidence interval −6·8 to −0·3), confirmed by intention‐to‐treat analysis. Additionally, regardless of the treatment used, 96% of mild lesions were maintained in complete response 24 weeks after the <fc>PDT</fc> session. For <fc>DL</fc>‐<fc>PDT</fc>, subject‐reported pain was significantly lower (0·8 vs. 5·7, respectively; <i>P </i><<i> </i>0·001), with better tolerability and significantly higher subject satisfaction regarding convenience and outcome.</p></section><section xml:id="bjd13138-sec-0005"><title type="main">Conclusions</title><p>Daylight‐mediated <fc>PDT</fc> was not inferior in efficacy to <fc>M</fc>etvix c‐<fc>PDT</fc> (mild <fc>AK</fc> response rate), better tolerated, nearly painless and more convenient for patients.</p></section></abstract><abstract type="short" xml:id="bjd13138-abs-0002"><p><b>What's already known about this topic?</b></p><p><list formatted="paragraph" style="bulleted" xml:id="bjd13138-list-0001"><listItem>Methyl aminolevulinate conventional photodynamic therapy (<fc>MAL</fc> c‐<fc>PDT</fc>) is effective for treating actinic keratosis (<fc>AK</fc>), but may be a painful, inconvenient procedure. Daylight <fc>PDT</fc> (<fc>DL</fc>‐<fc>PDT</fc>) has shown good efficacy and safety results compared with c‐<fc>PDT</fc> in a previous randomized, controlled, exploratory trial.</listItem></list></p><p><b>What does this study add?</b></p><p><list formatted="paragraph" style="bulleted" xml:id="bjd13138-list-0002"><listItem>This study confirms previous findings that <fc>DL</fc>‐<fc>PDT</fc> can be considered as an effective, safe and convenient alternative for the treatment of facial/scalp <fc>AK</fc>.</listItem><listItem>This is the first study showing a high maintenance of complete lesion response 6 months after one treatment.</listItem></list></p></abstract></abstractGroup></contentMeta><noteGroup xml:id="bjd13138-ntgp-0001"><note numbered="no" xml:id="bjd13138-note-0001"><p><b>Funding sources</b></p><p>This study was funded by Galderma R&D.</p></note><note numbered="no" xml:id="bjd13138-note-0002"><p><b>Conflicts of interest</b></p><p>The investigators received grants for conducting the studies. D.K. and N.K. are employees of Galderma R&D., and C.B. was a previous employee of Galderma R&D.</p></note></noteGroup></header></component></istex:document></istex:metadataXml><mods version="3.6"><titleInfo lang="en"><title>Daylight photodynamic therapy with methyl aminolevulinate cream as a convenient, similarly effective, nearly painless alternative to conventional photodynamic therapy in actinic keratosis treatment: a randomized controlled trial</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>Daylight photodynamic therapy with methyl aminolevulinate cream as a convenient, similarly effective, nearly painless alternative to conventional photodynamic therapy in actinic keratosis treatment: a randomized controlled trial</title></titleInfo><name type="personal"><namePart type="given">D.M.</namePart><namePart type="family">Rubel</namePart><affiliation>Woden Dermatology and Probity Medical Research, Level 1, 1 Bowes Place, 2606, Phillip, ACT, Australia</affiliation><affiliation>Australian National University, Canberra, Australia</affiliation><affiliation>.:</affiliation><affiliation>E-mail: diana@wodendermatology.com.au</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">L.</namePart><namePart type="family">Spelman</namePart><affiliation>Specialist Connect, Qld, Woolloongabba, Australia</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">D.F.</namePart><namePart type="family">Murrell</namePart><affiliation>Premier Specialists, KogarahSydney, NSW, Australia</affiliation><affiliation>University of NSW, NSW, Sydney, Australia</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">J.‐A.</namePart><namePart type="family">See</namePart><affiliation>Central Sydney Dermatology, NSW, Sydney, Australia</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">D.</namePart><namePart type="family">Hewitt</namePart><affiliation>Skin and Cancer Foundation, NSW, Westmead, Australia</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">P.</namePart><namePart type="family">Foley</namePart><affiliation>Skin and Cancer Foundation Inc., Carlton, Vic., Australia</affiliation><affiliation>The University of Melbourne, Parkville, Vic., Australia</affiliation><affiliation>St Vincent's Hospital, Vic., FitzroyMelbourne, Australia</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">C.</namePart><namePart type="family">Bosc</namePart><affiliation>Galderma R&D, Sophia Antipolis, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">D.</namePart><namePart type="family">Kerob</namePart><affiliation>Galderma International, Paris, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">N.</namePart><namePart type="family">Kerrouche</namePart><affiliation>Galderma R&D, Sophia Antipolis, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">H.C.</namePart><namePart type="family">Wulf</namePart><affiliation>Bispebjerg Hospital, Copenhagen University, Copenhagen, Denmark</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">S.</namePart><namePart type="family">Shumack</namePart><affiliation>St George Dermatology and Skin Cancer Centre and Probity Medical Research, Kogarah, NSW, Sydney, Australia</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><dateIssued encoding="w3cdtf">2014-11</dateIssued><dateCreated encoding="w3cdtf">2014-08-08</dateCreated><dateValid encoding="w3cdtf">2014-05-20</dateValid><copyrightDate encoding="w3cdtf">2014</copyrightDate></originInfo><language><languageTerm type="code" authority="rfc3066">en</languageTerm><languageTerm type="code" authority="iso639-2b">eng</languageTerm></language><abstract>Daylight photodynamic therapy (DL‐PDT) of actinic keratosis (AK) has shown preliminary efficacy and safety results comparable to conventional photodynamic therapy (c‐PDT), using methyl aminolevulinate (MAL) cream.</abstract><abstract>To demonstrate the efficacy and safety of DL‐PDT vs. c‐PDT in treating mild facial/scalp AK.</abstract><abstract>This 24‐week randomized, controlled, investigator‐blinded, multicentre, intra‐individual efficacy (non‐inferiority) and safety (superiority regarding pain) study enrolled 100 subjects. AKs on the face/scalp were treated once, with DL‐PDT on one side and c‐PDT on the contralateral side. Primary end points for DL‐PDT at week 12 were efficacy [non‐inferiority regarding complete lesion response (mild AK)] and safety (superiority regarding subject's assessment of pain). Lesions with complete response 12 weeks after one treatment session were followed until week 24. The safety evaluation included incidence of adverse events. Subject satisfaction was classified using a questionnaire.</abstract><abstract>At week 12, the complete lesion response rate with DL‐PDT was non‐inferior to c‐PDT (89·2% vs. 92·8%, respectively; 95% confidence interval −6·8 to −0·3), confirmed by intention‐to‐treat analysis. Additionally, regardless of the treatment used, 96% of mild lesions were maintained in complete response 24 weeks after the PDT session. For DL‐PDT, subject‐reported pain was significantly lower (0·8 vs. 5·7, respectively; P < 0·001), with better tolerability and significantly higher subject satisfaction regarding convenience and outcome.</abstract><abstract>Daylight‐mediated PDT was not inferior in efficacy to Metvix c‐PDT (mild AK response rate), better tolerated, nearly painless and more convenient for patients.</abstract><abstract>What's already known about this topic?</abstract><abstract>Methyl aminolevulinate conventional photodynamic therapy (MAL c‐PDT) is effective for treating actinic keratosis (AK), but may be a painful, inconvenient procedure. Daylight PDT (DL‐PDT) has shown good efficacy and safety results compared with c‐PDT in a previous randomized, controlled, exploratory trial.</abstract><abstract>What does this study add?</abstract><abstract>This study confirms previous findings that DL‐PDT can be considered as an effective, safe and convenient alternative for the treatment of facial/scalp AK. This is the first study showing a high maintenance of complete lesion response 6 months after one treatment.</abstract><note type="funding">Galderma R&D</note><relatedItem type="host"><titleInfo><title>British Journal of Dermatology</title></titleInfo><titleInfo type="abbreviated"><title>Br J Dermatol</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>Photobiology</topic></subject><identifier type="ISSN">0007-0963</identifier><identifier type="eISSN">1365-2133</identifier><identifier type="DOI">10.1111/(ISSN)1365-2133</identifier><identifier type="PublisherID">BJD</identifier><part><date>2014</date><detail type="volume"><caption>vol.</caption><number>171</number></detail><detail type="issue"><caption>no.</caption><number>5</number></detail><extent unit="pages"><start>1164</start><end>1171</end><total>8</total></extent></part></relatedItem><identifier type="istex">A07243A6DDCC5B26542FD1C68AAB9345B287AD28</identifier><identifier type="ark">ark:/67375/WNG-5BKVL18V-4</identifier><identifier type="DOI">10.1111/bjd.13138</identifier><identifier type="ArticleID">BJD13138</identifier><accessCondition type="use and reproduction" contentType="copyright">Copyright © 2014 British Association of Dermatologists© 2014 British Association of Dermatologists</accessCondition><recordInfo><recordContentSource authority="ISTEX" authorityURI="https://loaded-corpus.data.istex.fr" valueURI="https://loaded-corpus.data.istex.fr/ark:/67375/XBH-L0C46X92-X">wiley</recordContentSource></recordInfo></mods><json:item><extension>json</extension><original>false</original><mimetype>application/json</mimetype><uri>https://api.istex.fr/document/A07243A6DDCC5B26542FD1C68AAB9345B287AD28/metadata/json</uri></json:item></metadata><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
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