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 : 004289 ( Main/Merge ); précédent : 004288; suivant : 004290Daylight 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 [Australie] ; L. Spelman ; D. F. Murrell [Australie] ; J.-A. See [Australie] ; D. Hewitt [Australie] ; P. Foley [Australie] ; C. Bosc [France] ; D. Kerob [France] ; N. Kerrouche [France] ; H. C. Wulf [Danemark] ; S. Shumack [Australie]Source :
- British journal of dermatology : (1951) [ 0007-0963 ] ; 2014.
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Abstract
Background 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. Objectives To demonstrate the efficacy and safety of DL-PDT vs. c-PDT in treating mild facial/scalp AK. Materials and methods 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. Results 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. Conclusions 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.
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en" level="a">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><author><name sortKey="Rubel, D M" sort="Rubel, D M" uniqKey="Rubel D" first="D. M." last="Rubel">D. M. Rubel</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Woden Dermatology and Probity Medical Research, Level I, 1 Bowes Place</s1><s2>Phillip, ACT 2606</s2><s3>AUS</s3><sZ>1 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Phillip, ACT 2606</wicri:noRegion></affiliation><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Australian National University</s1><s2>Canberra</s2><s3>AUS</s3><sZ>1 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Australian National University</wicri:noRegion></affiliation></author><author><name sortKey="Spelman, L" sort="Spelman, L" uniqKey="Spelman L" first="L." last="Spelman">L. Spelman</name></author><author><name sortKey="Murrell, D F" sort="Murrell, D F" uniqKey="Murrell D" first="D. F." last="Murrell">D. F. Murrell</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>University of NSW</s1><s2>Sydney, NSW</s2><s3>AUS</s3><sZ>3 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>University of NSW</wicri:noRegion></affiliation></author><author><name sortKey="See, J A" sort="See, J A" uniqKey="See J" first="J.-A." last="See">J.-A. See</name><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Central Sydney Dermatology</s1><s2>Sydney, NSW</s2><s3>AUS</s3><sZ>4 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Central Sydney Dermatology</wicri:noRegion></affiliation></author><author><name sortKey="Hewitt, D" sort="Hewitt, D" uniqKey="Hewitt D" first="D." last="Hewitt">D. Hewitt</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Skin and Cancer Foundation</s1><s2>Westmead, NSW</s2><s3>AUS</s3><sZ>5 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Skin and Cancer Foundation</wicri:noRegion></affiliation></author><author><name sortKey="Foley, P" sort="Foley, P" uniqKey="Foley P" first="P." last="Foley">P. Foley</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Skin and Cancer Foundation Inc.</s1><s2>Carlton, Vic.</s2><s3>AUS</s3><sZ>6 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Skin and Cancer Foundation Inc.</wicri:noRegion></affiliation><affiliation wicri:level="4"><inist:fA14 i1="07"><s1>The University of Melbourne</s1><s2>Parkville, Vic.</s2><s3>AUS</s3><sZ>6 aut.</sZ></inist:fA14><country>Australie</country><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName><orgName type="university">Université de Melbourne</orgName></affiliation><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>St Vincent's Hospital</s1><s2>Fitzroy Melbourne, Vic.</s2><s3>AUS</s3><sZ>6 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>St Vincent's Hospital</wicri:noRegion></affiliation></author><author><name sortKey="Bosc, C" sort="Bosc, C" uniqKey="Bosc C" first="C." last="Bosc">C. Bosc</name><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Galderma R&D</s1><s2>Sophia Antipolis</s2><s3>FRA</s3><sZ>7 aut.</sZ><sZ>9 aut.</sZ></inist:fA14><country>France</country><wicri:noRegion>Sophia Antipolis</wicri:noRegion><wicri:noRegion>Galderma R&D</wicri:noRegion><wicri:noRegion>Galderma R&D</wicri:noRegion></affiliation></author><author><name sortKey="Kerob, D" sort="Kerob, D" uniqKey="Kerob D" first="D." last="Kerob">D. Kerob</name><affiliation wicri:level="3"><inist:fA14 i1="10"><s1>Calderma International</s1><s2>Paris</s2><s3>FRA</s3><sZ>8 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Kerrouche, N" sort="Kerrouche, N" uniqKey="Kerrouche N" first="N." last="Kerrouche">N. Kerrouche</name><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Galderma R&D</s1><s2>Sophia Antipolis</s2><s3>FRA</s3><sZ>7 aut.</sZ><sZ>9 aut.</sZ></inist:fA14><country>France</country><wicri:noRegion>Sophia Antipolis</wicri:noRegion><wicri:noRegion>Galderma R&D</wicri:noRegion><wicri:noRegion>Galderma R&D</wicri:noRegion></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 wicri:level="3"><inist:fA14 i1="11"><s1>Bispebjerg Hospital, Copenhagen University</s1><s2>Copenhagen</s2><s3>DNK</s3><sZ>10 aut.</sZ></inist:fA14><country>Danemark</country><placeName><settlement type="city">Copenhague</settlement><region type="région" nuts="2">Hovedstaden</region></placeName></affiliation></author><author><name sortKey="Shumack, S" sort="Shumack, S" uniqKey="Shumack S" first="S." last="Shumack">S. Shumack</name><affiliation wicri:level="1"><inist:fA14 i1="12"><s1>St George Dermatology and Skin Cancer Centre and Probity Medical Research</s1><s2>Kogarah, Sydney, NSW</s2><s3>AUS</s3><sZ>11 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>St George Dermatology and Skin Cancer Centre and Probity Medical Research</wicri:noRegion></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">14-0280096</idno><date when="2014">2014</date><idno type="stanalyst">PASCAL 14-0280096 INIST</idno><idno type="RBID">Pascal:14-0280096</idno><idno type="wicri:Area/PascalFrancis/Corpus">000175</idno><idno type="wicri:Area/PascalFrancis/Curation">005C91</idno><idno type="wicri:Area/PascalFrancis/Checkpoint">000365</idno><idno type="wicri:explorRef" wicri:stream="PascalFrancis" wicri:step="Checkpoint">000365</idno><idno type="wicri:doubleKey">0007-0963:2014:Rubel D:daylight:photodynamic:therapy</idno><idno type="wicri:Area/Main/Merge">004289</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">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><author><name sortKey="Rubel, D M" sort="Rubel, D M" uniqKey="Rubel D" first="D. M." last="Rubel">D. M. Rubel</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Woden Dermatology and Probity Medical Research, Level I, 1 Bowes Place</s1><s2>Phillip, ACT 2606</s2><s3>AUS</s3><sZ>1 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Phillip, ACT 2606</wicri:noRegion></affiliation><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Australian National University</s1><s2>Canberra</s2><s3>AUS</s3><sZ>1 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Australian National University</wicri:noRegion></affiliation></author><author><name sortKey="Spelman, L" sort="Spelman, L" uniqKey="Spelman L" first="L." last="Spelman">L. Spelman</name></author><author><name sortKey="Murrell, D F" sort="Murrell, D F" uniqKey="Murrell D" first="D. F." last="Murrell">D. F. Murrell</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>University of NSW</s1><s2>Sydney, NSW</s2><s3>AUS</s3><sZ>3 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>University of NSW</wicri:noRegion></affiliation></author><author><name sortKey="See, J A" sort="See, J A" uniqKey="See J" first="J.-A." last="See">J.-A. See</name><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Central Sydney Dermatology</s1><s2>Sydney, NSW</s2><s3>AUS</s3><sZ>4 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Central Sydney Dermatology</wicri:noRegion></affiliation></author><author><name sortKey="Hewitt, D" sort="Hewitt, D" uniqKey="Hewitt D" first="D." last="Hewitt">D. Hewitt</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Skin and Cancer Foundation</s1><s2>Westmead, NSW</s2><s3>AUS</s3><sZ>5 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Skin and Cancer Foundation</wicri:noRegion></affiliation></author><author><name sortKey="Foley, P" sort="Foley, P" uniqKey="Foley P" first="P." last="Foley">P. Foley</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Skin and Cancer Foundation Inc.</s1><s2>Carlton, Vic.</s2><s3>AUS</s3><sZ>6 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Skin and Cancer Foundation Inc.</wicri:noRegion></affiliation><affiliation wicri:level="4"><inist:fA14 i1="07"><s1>The University of Melbourne</s1><s2>Parkville, Vic.</s2><s3>AUS</s3><sZ>6 aut.</sZ></inist:fA14><country>Australie</country><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName><orgName type="university">Université de Melbourne</orgName></affiliation><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>St Vincent's Hospital</s1><s2>Fitzroy Melbourne, Vic.</s2><s3>AUS</s3><sZ>6 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>St Vincent's Hospital</wicri:noRegion></affiliation></author><author><name sortKey="Bosc, C" sort="Bosc, C" uniqKey="Bosc C" first="C." last="Bosc">C. Bosc</name><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Galderma R&D</s1><s2>Sophia Antipolis</s2><s3>FRA</s3><sZ>7 aut.</sZ><sZ>9 aut.</sZ></inist:fA14><country>France</country><wicri:noRegion>Sophia Antipolis</wicri:noRegion><wicri:noRegion>Galderma R&D</wicri:noRegion><wicri:noRegion>Galderma R&D</wicri:noRegion></affiliation></author><author><name sortKey="Kerob, D" sort="Kerob, D" uniqKey="Kerob D" first="D." last="Kerob">D. Kerob</name><affiliation wicri:level="3"><inist:fA14 i1="10"><s1>Calderma International</s1><s2>Paris</s2><s3>FRA</s3><sZ>8 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Kerrouche, N" sort="Kerrouche, N" uniqKey="Kerrouche N" first="N." last="Kerrouche">N. Kerrouche</name><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Galderma R&D</s1><s2>Sophia Antipolis</s2><s3>FRA</s3><sZ>7 aut.</sZ><sZ>9 aut.</sZ></inist:fA14><country>France</country><wicri:noRegion>Sophia Antipolis</wicri:noRegion><wicri:noRegion>Galderma R&D</wicri:noRegion><wicri:noRegion>Galderma R&D</wicri:noRegion></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 wicri:level="3"><inist:fA14 i1="11"><s1>Bispebjerg Hospital, Copenhagen University</s1><s2>Copenhagen</s2><s3>DNK</s3><sZ>10 aut.</sZ></inist:fA14><country>Danemark</country><placeName><settlement type="city">Copenhague</settlement><region type="région" nuts="2">Hovedstaden</region></placeName></affiliation></author><author><name sortKey="Shumack, S" sort="Shumack, S" uniqKey="Shumack S" first="S." last="Shumack">S. Shumack</name><affiliation wicri:level="1"><inist:fA14 i1="12"><s1>St George Dermatology and Skin Cancer Centre and Probity Medical Research</s1><s2>Kogarah, Sydney, NSW</s2><s3>AUS</s3><sZ>11 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>St George Dermatology and Skin Cancer Centre and Probity Medical Research</wicri:noRegion></affiliation></author></analytic><series><title level="j" type="main">British journal of dermatology : (1951)</title><title level="j" type="abbreviated">Br. j. dermatol. : (1951)</title><idno type="ISSN">0007-0963</idno><imprint><date when="2014">2014</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">British journal of dermatology : (1951)</title><title level="j" type="abbreviated">Br. j. dermatol. : (1951)</title><idno type="ISSN">0007-0963</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Clinical trial</term><term>Cream</term><term>Daylight</term><term>Dermatology</term><term>Keratosis senilis</term><term>Methyl aminolevulinate</term><term>Photodynamic therapy</term><term>Randomization</term><term>Randomized controlled trial</term><term>Treatment</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Kératose sénile</term><term>Lumière naturelle</term><term>Traitement</term><term>Photothérapie dynamique</term><term>Crème</term><term>Essai clinique</term><term>Randomisation</term><term>Dermatologie</term><term>Aminolévulinate de méthyle</term><term>Essai randomisé contrôlé</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Crème</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Background 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. Objectives To demonstrate the efficacy and safety of DL-PDT vs. c-PDT in treating mild facial/scalp AK. Materials and methods 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. Results 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. Conclusions 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.</div></front></TEI><affiliations><list><country><li>Australie</li><li>Danemark</li><li>France</li></country><region><li>Hovedstaden</li><li>Victoria (État)</li><li>Île-de-France</li></region><settlement><li>Copenhague</li><li>Melbourne</li><li>Paris</li></settlement><orgName><li>Université de Melbourne</li></orgName></list><tree><noCountry><name sortKey="Spelman, L" sort="Spelman, L" uniqKey="Spelman L" first="L." last="Spelman">L. Spelman</name></noCountry><country name="Australie"><noRegion><name sortKey="Rubel, D M" sort="Rubel, D M" uniqKey="Rubel D" first="D. M." last="Rubel">D. M. Rubel</name></noRegion><name sortKey="Foley, P" sort="Foley, P" uniqKey="Foley P" first="P." last="Foley">P. Foley</name><name sortKey="Foley, P" sort="Foley, P" uniqKey="Foley P" first="P." last="Foley">P. Foley</name><name sortKey="Foley, P" sort="Foley, P" uniqKey="Foley P" first="P." last="Foley">P. Foley</name><name sortKey="Hewitt, D" sort="Hewitt, D" uniqKey="Hewitt D" first="D." last="Hewitt">D. Hewitt</name><name sortKey="Murrell, D F" sort="Murrell, D F" uniqKey="Murrell D" first="D. F." last="Murrell">D. F. Murrell</name><name sortKey="Rubel, D M" sort="Rubel, D M" uniqKey="Rubel D" first="D. M." last="Rubel">D. M. Rubel</name><name sortKey="See, J A" sort="See, J A" uniqKey="See J" first="J.-A." last="See">J.-A. See</name><name sortKey="Shumack, S" sort="Shumack, S" uniqKey="Shumack S" first="S." last="Shumack">S. Shumack</name></country><country name="France"><noRegion><name sortKey="Bosc, C" sort="Bosc, C" uniqKey="Bosc C" first="C." last="Bosc">C. Bosc</name></noRegion><name sortKey="Kerob, D" sort="Kerob, D" uniqKey="Kerob D" first="D." last="Kerob">D. Kerob</name><name sortKey="Kerrouche, N" sort="Kerrouche, N" uniqKey="Kerrouche N" first="N." last="Kerrouche">N. Kerrouche</name></country><country name="Danemark"><region name="Hovedstaden"><name sortKey="Wulf, H C" sort="Wulf, H C" uniqKey="Wulf H" first="H. C." last="Wulf">H. C. Wulf</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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