Photodynamic therapy for actinic keratosis of the forehead and scalp: a randomized, controlled, phase II clinical study evaluating the noninferiority of a new protocol involving irradiation with a light‐emitting, fabric‐based device (the Flexitheralight protocol) compared with the conventional protocol involving irradiation with the Aktilite CL 128 lamp
Summary Background Photodynamic therapy (PDT) is an effective treatment for actinic keratosis (AK), particularly for patients with large areas of field cancerization. Among the approved protocols in Europe, the most widely used requires irradiation with the Aktilite CL 128 lamp. However, pain during...
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| Veröffentlicht in: | British journal of dermatology (1951) 2019-04, Vol.180 (4), p.765-773 |
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| creator | Vicentini, C. Vignion‐Dewalle, A.S. Thecua, E. Lecomte, F. Maire, C. Deleporte, P. Béhal, H. Kerob, D. Duhamel, A. Mordon, S. Mortier, L. |
| description | Summary
Background
Photodynamic therapy (PDT) is an effective treatment for actinic keratosis (AK), particularly for patients with large areas of field cancerization. Among the approved protocols in Europe, the most widely used requires irradiation with the Aktilite CL 128 lamp. However, pain during irradiation and the suboptimal adaptability of the lamp relative to the treatment area are two limiting factors of this protocol. To overcome these limits, a new protocol (referred to as the Flexitheralight protocol) involving irradiation with a light‐emitting, fabric‐based device was developed.
Objectives
This paper aims to assess the noninferiority, in terms of PDT efficacy for treating AK, of the Flexitheralight protocol compared with the conventional protocol, which requires irradiation with the Aktilite CL 128 lamp.
Methods
A monocentric, randomized, controlled, phase II clinical study was performed. Twenty‐five patients with grade I–II AKs of the forehead and scalp were treated with methyl aminolaevulinate PDT in two symmetrical areas. One area was treated with the conventional protocol (n = 154 AKs), whereas the other area was treated with the Flexitheralight protocol (n = 156 AKs). The primary end‐point was the lesion complete response (CR) rate at 3 months (an absolute noninferiority margin of –10% was used). The secondary end‐points included patient‐reported pain at the end of the irradiation.
Results
At 3 months, the lesion CR rate with the Flexitheralight protocol was noninferior to that obtained with the conventional protocol (66·0% vs. 59·1%, respectively; absolute difference, 6·9%; 95% confidence interval –0·6% to 14·5%). Patient‐reported pain was significantly lower with the Flexitheralight protocol than with the conventional protocol (mean ± SD: 0·4 ± 0·6 vs. 5·0 ± 2·6; P < 0·0001).
Conclusions
The Flexitheralight protocol is noninferior in terms of efficacy and superior in terms of tolerability to the conventional protocol for treating AKs of the forehead and scalp.
What's already known about this topic?
Methyl aminolaevulinate photodynamic therapy (PDT) is an effective and noninvasive treatment for actinic keratosis (AK).
Treatment‐associated pain is frequently experienced by patients treated with the conventional protocol, which requires irradiation with the Aktilite CL 128 lamp.
PDT using daylight as the activating light source has been confirmed as equally effective and less painful than the conventional protocol, but it cannot be performe |
| doi_str_mv | 10.1111/bjd.17350 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2126917932</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2200803780</sourcerecordid><originalsourceid>FETCH-LOGICAL-c3530-2a0d957d392575b854d7c34d5e4f252c8007bd108182f4a12e91c1fbd2d5326e3</originalsourceid><addsrcrecordid>eNqNks2O0zAUhQMCMaWw4AWQJTYz0nTGP02TsBsKA0WVYAHryLFvGnccO2M7LWHFI_CMPAlOO8wCCYlIUZyb755zrnKT5AXBFyRel9VWXpCMpfhhMiFskc4oYexRMsEYZzNcLNhJ8tT7LcaE4RQ_SU4YZotsnuHJg83nxgYrB8NbJVBowPFuQLV1iIugTKzdxFKwXnlk6xEYP0IDXCJuJPKC6-414sjFN9uq7yDPkbAmOKv1eO4a7gGtVkjoUY5r5EMvBwQ7rnseLTYHUWONMjU4ZZ0Kw2jFkYE96lyMJ6xGyuys3o24co5LFVutQXsVmkhqtWnCrx8_oVVhlDxHNa-cErFURXuJJOyUAHQ6Wl1r-KYOkx7a7i3OYu624y7iB9mRjZPswIxWMfj_ZBmbrm6C0ioAWq4RoTnSvO2eJY9rrj08v3tOk6_X774sP8zWn96vllfrmWApwzPKsSzSTLKCplla5elcZoLNZQrzmqZU5PGPVpLgnOS0nnNCoSCC1JWkMmV0AWyanB51Y9jbHnwoW-UFaM0N2N6XlNBFQbKC0Yi--gvd2t7FQSNFMc4xy-I9Tc6OlHDWewd12TnVcjeUBJfj9pVx-8rD9kX25Z1iX7Ug78k_6xaByyOwVxqGfyuVbz6-PUr-BlRl7gU</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2200803780</pqid></control><display><type>article</type><title>Photodynamic therapy for actinic keratosis of the forehead and scalp: a randomized, controlled, phase II clinical study evaluating the noninferiority of a new protocol involving irradiation with a light‐emitting, fabric‐based device (the Flexitheralight protocol) compared with the conventional protocol involving irradiation with the Aktilite CL 128 lamp</title><source>MEDLINE</source><source>Access via Wiley Online Library</source><source>Oxford University Press Journals All Titles (1996-Current)</source><creator>Vicentini, C. ; Vignion‐Dewalle, A.S. ; Thecua, E. ; Lecomte, F. ; Maire, C. ; Deleporte, P. ; Béhal, H. ; Kerob, D. ; Duhamel, A. ; Mordon, S. ; Mortier, L.</creator><creatorcontrib>Vicentini, C. ; Vignion‐Dewalle, A.S. ; Thecua, E. ; Lecomte, F. ; Maire, C. ; Deleporte, P. ; Béhal, H. ; Kerob, D. ; Duhamel, A. ; Mordon, S. ; Mortier, L.</creatorcontrib><description>Summary
Background
Photodynamic therapy (PDT) is an effective treatment for actinic keratosis (AK), particularly for patients with large areas of field cancerization. Among the approved protocols in Europe, the most widely used requires irradiation with the Aktilite CL 128 lamp. However, pain during irradiation and the suboptimal adaptability of the lamp relative to the treatment area are two limiting factors of this protocol. To overcome these limits, a new protocol (referred to as the Flexitheralight protocol) involving irradiation with a light‐emitting, fabric‐based device was developed.
Objectives
This paper aims to assess the noninferiority, in terms of PDT efficacy for treating AK, of the Flexitheralight protocol compared with the conventional protocol, which requires irradiation with the Aktilite CL 128 lamp.
Methods
A monocentric, randomized, controlled, phase II clinical study was performed. Twenty‐five patients with grade I–II AKs of the forehead and scalp were treated with methyl aminolaevulinate PDT in two symmetrical areas. One area was treated with the conventional protocol (n = 154 AKs), whereas the other area was treated with the Flexitheralight protocol (n = 156 AKs). The primary end‐point was the lesion complete response (CR) rate at 3 months (an absolute noninferiority margin of –10% was used). The secondary end‐points included patient‐reported pain at the end of the irradiation.
Results
At 3 months, the lesion CR rate with the Flexitheralight protocol was noninferior to that obtained with the conventional protocol (66·0% vs. 59·1%, respectively; absolute difference, 6·9%; 95% confidence interval –0·6% to 14·5%). Patient‐reported pain was significantly lower with the Flexitheralight protocol than with the conventional protocol (mean ± SD: 0·4 ± 0·6 vs. 5·0 ± 2·6; P < 0·0001).
Conclusions
The Flexitheralight protocol is noninferior in terms of efficacy and superior in terms of tolerability to the conventional protocol for treating AKs of the forehead and scalp.
What's already known about this topic?
Methyl aminolaevulinate photodynamic therapy (PDT) is an effective and noninvasive treatment for actinic keratosis (AK).
Treatment‐associated pain is frequently experienced by patients treated with the conventional protocol, which requires irradiation with the Aktilite CL 128 lamp.
PDT using daylight as the activating light source has been confirmed as equally effective and less painful than the conventional protocol, but it cannot be performed in all weather conditions.
What does this study add?
This study demonstrates that the Flexitheralight protocol, which can be performed in all weather conditions, is equally effective as the conventional PDT protocol for AK and is a less painful technique.
Linked Comment: Morton. Br J Dermatol 2019; 180:703–704.
Respond to this article
Plain language summary available online</description><identifier>ISSN: 0007-0963</identifier><identifier>EISSN: 1365-2133</identifier><identifier>DOI: 10.1111/bjd.17350</identifier><identifier>PMID: 30367470</identifier><language>eng</language><publisher>England: Oxford University Press</publisher><subject>Adaptability ; Aged ; Aged, 80 and over ; Aminolevulinic Acid - administration & dosage ; Aminolevulinic Acid - adverse effects ; Aminolevulinic Acid - analogs & derivatives ; Facial Dermatoses - drug therapy ; Facial Dermatoses - pathology ; Female ; Forehead ; Humans ; Keratosis ; Keratosis, Actinic - drug therapy ; Keratosis, Actinic - pathology ; Limiting factors ; Male ; Middle Aged ; Pain ; Pain Measurement ; Pain, Procedural - diagnosis ; Pain, Procedural - etiology ; Patient Reported Outcome Measures ; Patients ; Photochemotherapy - adverse effects ; Photochemotherapy - instrumentation ; Photochemotherapy - methods ; Photodynamic therapy ; Photosensitizing Agents - administration & dosage ; Photosensitizing Agents - adverse effects ; Scalp ; Scalp Dermatoses - drug therapy ; Scalp Dermatoses - pathology ; Severity of Illness Index ; Treatment Outcome</subject><ispartof>British journal of dermatology (1951), 2019-04, Vol.180 (4), p.765-773</ispartof><rights>2018 British Association of Dermatologists</rights><rights>2018 British Association of Dermatologists.</rights><rights>Copyright © 2019 British Association of Dermatologists</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3530-2a0d957d392575b854d7c34d5e4f252c8007bd108182f4a12e91c1fbd2d5326e3</citedby><cites>FETCH-LOGICAL-c3530-2a0d957d392575b854d7c34d5e4f252c8007bd108182f4a12e91c1fbd2d5326e3</cites><orcidid>0000-0003-0979-3310</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fbjd.17350$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fbjd.17350$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>315,781,785,1418,27929,27930,45579,45580</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30367470$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Vicentini, C.</creatorcontrib><creatorcontrib>Vignion‐Dewalle, A.S.</creatorcontrib><creatorcontrib>Thecua, E.</creatorcontrib><creatorcontrib>Lecomte, F.</creatorcontrib><creatorcontrib>Maire, C.</creatorcontrib><creatorcontrib>Deleporte, P.</creatorcontrib><creatorcontrib>Béhal, H.</creatorcontrib><creatorcontrib>Kerob, D.</creatorcontrib><creatorcontrib>Duhamel, A.</creatorcontrib><creatorcontrib>Mordon, S.</creatorcontrib><creatorcontrib>Mortier, L.</creatorcontrib><title>Photodynamic therapy for actinic keratosis of the forehead and scalp: a randomized, controlled, phase II clinical study evaluating the noninferiority of a new protocol involving irradiation with a light‐emitting, fabric‐based device (the Flexitheralight protocol) compared with the conventional protocol involving irradiation with the Aktilite CL 128 lamp</title><title>British journal of dermatology (1951)</title><addtitle>Br J Dermatol</addtitle><description>Summary
Background
Photodynamic therapy (PDT) is an effective treatment for actinic keratosis (AK), particularly for patients with large areas of field cancerization. Among the approved protocols in Europe, the most widely used requires irradiation with the Aktilite CL 128 lamp. However, pain during irradiation and the suboptimal adaptability of the lamp relative to the treatment area are two limiting factors of this protocol. To overcome these limits, a new protocol (referred to as the Flexitheralight protocol) involving irradiation with a light‐emitting, fabric‐based device was developed.
Objectives
This paper aims to assess the noninferiority, in terms of PDT efficacy for treating AK, of the Flexitheralight protocol compared with the conventional protocol, which requires irradiation with the Aktilite CL 128 lamp.
Methods
A monocentric, randomized, controlled, phase II clinical study was performed. Twenty‐five patients with grade I–II AKs of the forehead and scalp were treated with methyl aminolaevulinate PDT in two symmetrical areas. One area was treated with the conventional protocol (n = 154 AKs), whereas the other area was treated with the Flexitheralight protocol (n = 156 AKs). The primary end‐point was the lesion complete response (CR) rate at 3 months (an absolute noninferiority margin of –10% was used). The secondary end‐points included patient‐reported pain at the end of the irradiation.
Results
At 3 months, the lesion CR rate with the Flexitheralight protocol was noninferior to that obtained with the conventional protocol (66·0% vs. 59·1%, respectively; absolute difference, 6·9%; 95% confidence interval –0·6% to 14·5%). Patient‐reported pain was significantly lower with the Flexitheralight protocol than with the conventional protocol (mean ± SD: 0·4 ± 0·6 vs. 5·0 ± 2·6; P < 0·0001).
Conclusions
The Flexitheralight protocol is noninferior in terms of efficacy and superior in terms of tolerability to the conventional protocol for treating AKs of the forehead and scalp.
What's already known about this topic?
Methyl aminolaevulinate photodynamic therapy (PDT) is an effective and noninvasive treatment for actinic keratosis (AK).
Treatment‐associated pain is frequently experienced by patients treated with the conventional protocol, which requires irradiation with the Aktilite CL 128 lamp.
PDT using daylight as the activating light source has been confirmed as equally effective and less painful than the conventional protocol, but it cannot be performed in all weather conditions.
What does this study add?
This study demonstrates that the Flexitheralight protocol, which can be performed in all weather conditions, is equally effective as the conventional PDT protocol for AK and is a less painful technique.
Linked Comment: Morton. Br J Dermatol 2019; 180:703–704.
Respond to this article
Plain language summary available online</description><subject>Adaptability</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Aminolevulinic Acid - administration & dosage</subject><subject>Aminolevulinic Acid - adverse effects</subject><subject>Aminolevulinic Acid - analogs & derivatives</subject><subject>Facial Dermatoses - drug therapy</subject><subject>Facial Dermatoses - pathology</subject><subject>Female</subject><subject>Forehead</subject><subject>Humans</subject><subject>Keratosis</subject><subject>Keratosis, Actinic - drug therapy</subject><subject>Keratosis, Actinic - pathology</subject><subject>Limiting factors</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Pain</subject><subject>Pain Measurement</subject><subject>Pain, Procedural - diagnosis</subject><subject>Pain, Procedural - etiology</subject><subject>Patient Reported Outcome Measures</subject><subject>Patients</subject><subject>Photochemotherapy - adverse effects</subject><subject>Photochemotherapy - instrumentation</subject><subject>Photochemotherapy - methods</subject><subject>Photodynamic therapy</subject><subject>Photosensitizing Agents - administration & dosage</subject><subject>Photosensitizing Agents - adverse effects</subject><subject>Scalp</subject><subject>Scalp Dermatoses - drug therapy</subject><subject>Scalp Dermatoses - pathology</subject><subject>Severity of Illness Index</subject><subject>Treatment Outcome</subject><issn>0007-0963</issn><issn>1365-2133</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNks2O0zAUhQMCMaWw4AWQJTYz0nTGP02TsBsKA0WVYAHryLFvGnccO2M7LWHFI_CMPAlOO8wCCYlIUZyb755zrnKT5AXBFyRel9VWXpCMpfhhMiFskc4oYexRMsEYZzNcLNhJ8tT7LcaE4RQ_SU4YZotsnuHJg83nxgYrB8NbJVBowPFuQLV1iIugTKzdxFKwXnlk6xEYP0IDXCJuJPKC6-414sjFN9uq7yDPkbAmOKv1eO4a7gGtVkjoUY5r5EMvBwQ7rnseLTYHUWONMjU4ZZ0Kw2jFkYE96lyMJ6xGyuys3o24co5LFVutQXsVmkhqtWnCrx8_oVVhlDxHNa-cErFURXuJJOyUAHQ6Wl1r-KYOkx7a7i3OYu624y7iB9mRjZPswIxWMfj_ZBmbrm6C0ioAWq4RoTnSvO2eJY9rrj08v3tOk6_X774sP8zWn96vllfrmWApwzPKsSzSTLKCplla5elcZoLNZQrzmqZU5PGPVpLgnOS0nnNCoSCC1JWkMmV0AWyanB51Y9jbHnwoW-UFaM0N2N6XlNBFQbKC0Yi--gvd2t7FQSNFMc4xy-I9Tc6OlHDWewd12TnVcjeUBJfj9pVx-8rD9kX25Z1iX7Ug78k_6xaByyOwVxqGfyuVbz6-PUr-BlRl7gU</recordid><startdate>201904</startdate><enddate>201904</enddate><creator>Vicentini, C.</creator><creator>Vignion‐Dewalle, A.S.</creator><creator>Thecua, E.</creator><creator>Lecomte, F.</creator><creator>Maire, C.</creator><creator>Deleporte, P.</creator><creator>Béhal, H.</creator><creator>Kerob, D.</creator><creator>Duhamel, A.</creator><creator>Mordon, S.</creator><creator>Mortier, L.</creator><general>Oxford University Press</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7T5</scope><scope>H94</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0003-0979-3310</orcidid></search><sort><creationdate>201904</creationdate><title>Photodynamic therapy for actinic keratosis of the forehead and scalp: a randomized, controlled, phase II clinical study evaluating the noninferiority of a new protocol involving irradiation with a light‐emitting, fabric‐based device (the Flexitheralight protocol) compared with the conventional protocol involving irradiation with the Aktilite CL 128 lamp</title><author>Vicentini, C. ; Vignion‐Dewalle, A.S. ; Thecua, E. ; Lecomte, F. ; Maire, C. ; Deleporte, P. ; Béhal, H. ; Kerob, D. ; Duhamel, A. ; Mordon, S. ; Mortier, L.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3530-2a0d957d392575b854d7c34d5e4f252c8007bd108182f4a12e91c1fbd2d5326e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Adaptability</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Aminolevulinic Acid - administration & dosage</topic><topic>Aminolevulinic Acid - adverse effects</topic><topic>Aminolevulinic Acid - analogs & derivatives</topic><topic>Facial Dermatoses - drug therapy</topic><topic>Facial Dermatoses - pathology</topic><topic>Female</topic><topic>Forehead</topic><topic>Humans</topic><topic>Keratosis</topic><topic>Keratosis, Actinic - drug therapy</topic><topic>Keratosis, Actinic - pathology</topic><topic>Limiting factors</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Pain</topic><topic>Pain Measurement</topic><topic>Pain, Procedural - diagnosis</topic><topic>Pain, Procedural - etiology</topic><topic>Patient Reported Outcome Measures</topic><topic>Patients</topic><topic>Photochemotherapy - adverse effects</topic><topic>Photochemotherapy - instrumentation</topic><topic>Photochemotherapy - methods</topic><topic>Photodynamic therapy</topic><topic>Photosensitizing Agents - administration & dosage</topic><topic>Photosensitizing Agents - adverse effects</topic><topic>Scalp</topic><topic>Scalp Dermatoses - drug therapy</topic><topic>Scalp Dermatoses - pathology</topic><topic>Severity of Illness Index</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Vicentini, C.</creatorcontrib><creatorcontrib>Vignion‐Dewalle, A.S.</creatorcontrib><creatorcontrib>Thecua, E.</creatorcontrib><creatorcontrib>Lecomte, F.</creatorcontrib><creatorcontrib>Maire, C.</creatorcontrib><creatorcontrib>Deleporte, P.</creatorcontrib><creatorcontrib>Béhal, H.</creatorcontrib><creatorcontrib>Kerob, D.</creatorcontrib><creatorcontrib>Duhamel, A.</creatorcontrib><creatorcontrib>Mordon, S.</creatorcontrib><creatorcontrib>Mortier, L.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><collection>MEDLINE - Academic</collection><jtitle>British journal of dermatology (1951)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Vicentini, C.</au><au>Vignion‐Dewalle, A.S.</au><au>Thecua, E.</au><au>Lecomte, F.</au><au>Maire, C.</au><au>Deleporte, P.</au><au>Béhal, H.</au><au>Kerob, D.</au><au>Duhamel, A.</au><au>Mordon, S.</au><au>Mortier, L.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Photodynamic therapy for actinic keratosis of the forehead and scalp: a randomized, controlled, phase II clinical study evaluating the noninferiority of a new protocol involving irradiation with a light‐emitting, fabric‐based device (the Flexitheralight protocol) compared with the conventional protocol involving irradiation with the Aktilite CL 128 lamp</atitle><jtitle>British journal of dermatology (1951)</jtitle><addtitle>Br J Dermatol</addtitle><date>2019-04</date><risdate>2019</risdate><volume>180</volume><issue>4</issue><spage>765</spage><epage>773</epage><pages>765-773</pages><issn>0007-0963</issn><eissn>1365-2133</eissn><abstract>Summary
Background
Photodynamic therapy (PDT) is an effective treatment for actinic keratosis (AK), particularly for patients with large areas of field cancerization. Among the approved protocols in Europe, the most widely used requires irradiation with the Aktilite CL 128 lamp. However, pain during irradiation and the suboptimal adaptability of the lamp relative to the treatment area are two limiting factors of this protocol. To overcome these limits, a new protocol (referred to as the Flexitheralight protocol) involving irradiation with a light‐emitting, fabric‐based device was developed.
Objectives
This paper aims to assess the noninferiority, in terms of PDT efficacy for treating AK, of the Flexitheralight protocol compared with the conventional protocol, which requires irradiation with the Aktilite CL 128 lamp.
Methods
A monocentric, randomized, controlled, phase II clinical study was performed. Twenty‐five patients with grade I–II AKs of the forehead and scalp were treated with methyl aminolaevulinate PDT in two symmetrical areas. One area was treated with the conventional protocol (n = 154 AKs), whereas the other area was treated with the Flexitheralight protocol (n = 156 AKs). The primary end‐point was the lesion complete response (CR) rate at 3 months (an absolute noninferiority margin of –10% was used). The secondary end‐points included patient‐reported pain at the end of the irradiation.
Results
At 3 months, the lesion CR rate with the Flexitheralight protocol was noninferior to that obtained with the conventional protocol (66·0% vs. 59·1%, respectively; absolute difference, 6·9%; 95% confidence interval –0·6% to 14·5%). Patient‐reported pain was significantly lower with the Flexitheralight protocol than with the conventional protocol (mean ± SD: 0·4 ± 0·6 vs. 5·0 ± 2·6; P < 0·0001).
Conclusions
The Flexitheralight protocol is noninferior in terms of efficacy and superior in terms of tolerability to the conventional protocol for treating AKs of the forehead and scalp.
What's already known about this topic?
Methyl aminolaevulinate photodynamic therapy (PDT) is an effective and noninvasive treatment for actinic keratosis (AK).
Treatment‐associated pain is frequently experienced by patients treated with the conventional protocol, which requires irradiation with the Aktilite CL 128 lamp.
PDT using daylight as the activating light source has been confirmed as equally effective and less painful than the conventional protocol, but it cannot be performed in all weather conditions.
What does this study add?
This study demonstrates that the Flexitheralight protocol, which can be performed in all weather conditions, is equally effective as the conventional PDT protocol for AK and is a less painful technique.
Linked Comment: Morton. Br J Dermatol 2019; 180:703–704.
Respond to this article
Plain language summary available online</abstract><cop>England</cop><pub>Oxford University Press</pub><pmid>30367470</pmid><doi>10.1111/bjd.17350</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0003-0979-3310</orcidid></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0007-0963 |
| ispartof | British journal of dermatology (1951), 2019-04, Vol.180 (4), p.765-773 |
| issn | 0007-0963 1365-2133 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_2126917932 |
| source | MEDLINE; Access via Wiley Online Library; Oxford University Press Journals All Titles (1996-Current) |
| subjects | Adaptability Aged Aged, 80 and over Aminolevulinic Acid - administration & dosage Aminolevulinic Acid - adverse effects Aminolevulinic Acid - analogs & derivatives Facial Dermatoses - drug therapy Facial Dermatoses - pathology Female Forehead Humans Keratosis Keratosis, Actinic - drug therapy Keratosis, Actinic - pathology Limiting factors Male Middle Aged Pain Pain Measurement Pain, Procedural - diagnosis Pain, Procedural - etiology Patient Reported Outcome Measures Patients Photochemotherapy - adverse effects Photochemotherapy - instrumentation Photochemotherapy - methods Photodynamic therapy Photosensitizing Agents - administration & dosage Photosensitizing Agents - adverse effects Scalp Scalp Dermatoses - drug therapy Scalp Dermatoses - pathology Severity of Illness Index Treatment Outcome |
| title | Photodynamic therapy for actinic keratosis of the forehead and scalp: a randomized, controlled, phase II clinical study evaluating the noninferiority of a new protocol involving irradiation with a light‐emitting, fabric‐based device (the Flexitheralight protocol) compared with the conventional protocol involving irradiation with the Aktilite CL 128 lamp |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-12-12T04%3A42%3A47IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Photodynamic%20therapy%20for%20actinic%20keratosis%20of%20the%20forehead%20and%20scalp:%20a%20randomized,%20controlled,%20phase%20II%20clinical%20study%20evaluating%20the%20noninferiority%20of%20a%20new%20protocol%20involving%20irradiation%20with%20a%20light%E2%80%90emitting,%20fabric%E2%80%90based%20device%20(the%20Flexitheralight%20protocol)%20compared%20with%20the%20conventional%20protocol%20involving%20irradiation%20with%20the%20Aktilite%20CL%20128%20lamp&rft.jtitle=British%20journal%20of%20dermatology%20(1951)&rft.au=Vicentini,%20C.&rft.date=2019-04&rft.volume=180&rft.issue=4&rft.spage=765&rft.epage=773&rft.pages=765-773&rft.issn=0007-0963&rft.eissn=1365-2133&rft_id=info:doi/10.1111/bjd.17350&rft_dat=%3Cproquest_cross%3E2200803780%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2200803780&rft_id=info:pmid/30367470&rfr_iscdi=true |