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Photodynamic therapy with a 5‐ALA patch does not increase the risk of conversion of actinic keratoses into squamous cell carcinoma : Results of a multicentre non‐interventional stu...
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Zeitschriftentitel: | Experimental Dermatology |
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Personen und Körperschaften: | , , , , , , , , , |
In: | Experimental Dermatology, 27, 2018, 12, S. 1399-1402 |
Format: | E-Article |
Sprache: | Englisch |
veröffentlicht: |
Wiley
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Schlagwörter: |
author_facet |
Reinhold, Uwe Petering, Holger Dirschka, Thomas Rozsondai, András Gille, Jens Kurzen, Hjalmar Ostendorf, Rolf Ebeling, Andrea Stocker, Marcus Radny, Peter Reinhold, Uwe Petering, Holger Dirschka, Thomas Rozsondai, András Gille, Jens Kurzen, Hjalmar Ostendorf, Rolf Ebeling, Andrea Stocker, Marcus Radny, Peter |
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author |
Reinhold, Uwe Petering, Holger Dirschka, Thomas Rozsondai, András Gille, Jens Kurzen, Hjalmar Ostendorf, Rolf Ebeling, Andrea Stocker, Marcus Radny, Peter |
spellingShingle |
Reinhold, Uwe Petering, Holger Dirschka, Thomas Rozsondai, András Gille, Jens Kurzen, Hjalmar Ostendorf, Rolf Ebeling, Andrea Stocker, Marcus Radny, Peter Experimental Dermatology Photodynamic therapy with a 5‐ALA patch does not increase the risk of conversion of actinic keratoses into squamous cell carcinoma : Results of a multicentre non‐interventional study Dermatology Molecular Biology Biochemistry |
author_sort |
reinhold, uwe |
spelling |
Reinhold, Uwe Petering, Holger Dirschka, Thomas Rozsondai, András Gille, Jens Kurzen, Hjalmar Ostendorf, Rolf Ebeling, Andrea Stocker, Marcus Radny, Peter 0906-6705 1600-0625 Wiley Dermatology Molecular Biology Biochemistry http://dx.doi.org/10.1111/exd.13804 <jats:title>Abstract</jats:title><jats:sec><jats:title>Background</jats:title><jats:p>It is important to collect data about the risk of transformation of an actinic keratosis (AK) lesion into squamous cell carcinoma (SCC) after a single photodynamic therapy (PDT) with 5‐ALA patch for a longer follow‐up period under daily routine.</jats:p></jats:sec><jats:sec><jats:title>Questions addressed</jats:title><jats:p>The purpose of this non‐interventional study (NIS) was to collect data on the frequency of occurrence of SCCs in the treated area during an interval of 2 years after a single 5‐ALA patch‐PDT.</jats:p></jats:sec><jats:sec><jats:title>Experimental design</jats:title><jats:p>This prospective observational case‐only study included patients with mild AK lesions on the head and face treated with 5‐ALA patch‐PDT according to the Summary of Product Characteristics (SPC).</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>In 370 patients, the risk of transformation of their treated AK lesion into SCC was 0.073% with its exact 95% confidence interval using the Poisson distribution of [0.009%, 0.262%]. The rate of complete clinical clearance on lesion basis after 3 months was 84.3%.</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>The efficacy and the safety results show no observation of an increased risk for conversion of an AK into a SCC 2 years after a single 5‐ALA patch‐PDT. Additionally, the high clinical complete remission rate under routine conditions is comparable to the rates observed in the approval trials.</jats:p></jats:sec> Results of a multicentre non‐interventional study Photodynamic therapy with a 5‐ALA patch does not increase the risk of conversion of actinic keratoses into squamous cell carcinoma : Results of a multicentre non‐interventional study Experimental Dermatology |
doi_str_mv |
10.1111/exd.13804 |
facet_avail |
Online |
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Medizin Biologie Chemie und Pharmazie |
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ElectronicArticle |
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Wiley, 2018 |
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2018 |
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Wiley |
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Experimental Dermatology |
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title_sub |
Results of a multicentre non‐interventional study |
title |
Photodynamic therapy with a 5‐ALA patch does not increase the risk of conversion of actinic keratoses into squamous cell carcinoma : Results of a multicentre non‐interventional study |
title_unstemmed |
Photodynamic therapy with a 5‐ALA patch does not increase the risk of conversion of actinic keratoses into squamous cell carcinoma : Results of a multicentre non‐interventional study |
title_full |
Photodynamic therapy with a 5‐ALA patch does not increase the risk of conversion of actinic keratoses into squamous cell carcinoma : Results of a multicentre non‐interventional study |
title_fullStr |
Photodynamic therapy with a 5‐ALA patch does not increase the risk of conversion of actinic keratoses into squamous cell carcinoma : Results of a multicentre non‐interventional study |
title_full_unstemmed |
Photodynamic therapy with a 5‐ALA patch does not increase the risk of conversion of actinic keratoses into squamous cell carcinoma : Results of a multicentre non‐interventional study |
title_short |
Photodynamic therapy with a 5‐ALA patch does not increase the risk of conversion of actinic keratoses into squamous cell carcinoma : Results of a multicentre non‐interventional study |
title_sort |
photodynamic therapy with a 5‐ala patch does not increase the risk of conversion of actinic keratoses into squamous cell carcinoma : results of a multicentre non‐interventional study |
topic |
Dermatology Molecular Biology Biochemistry |
url |
http://dx.doi.org/10.1111/exd.13804 |
publishDate |
2018 |
physical |
1399-1402 |
description |
<jats:title>Abstract</jats:title><jats:sec><jats:title>Background</jats:title><jats:p>It is important to collect data about the risk of transformation of an actinic keratosis (AK) lesion into squamous cell carcinoma (SCC) after a single photodynamic therapy (PDT) with 5‐ALA patch for a longer follow‐up period under daily routine.</jats:p></jats:sec><jats:sec><jats:title>Questions addressed</jats:title><jats:p>The purpose of this non‐interventional study (NIS) was to collect data on the frequency of occurrence of SCCs in the treated area during an interval of 2 years after a single 5‐ALA patch‐PDT.</jats:p></jats:sec><jats:sec><jats:title>Experimental design</jats:title><jats:p>This prospective observational case‐only study included patients with mild AK lesions on the head and face treated with 5‐ALA patch‐PDT according to the Summary of Product Characteristics (SPC).</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>In 370 patients, the risk of transformation of their treated AK lesion into SCC was 0.073% with its exact 95% confidence interval using the Poisson distribution of [0.009%, 0.262%]. The rate of complete clinical clearance on lesion basis after 3 months was 84.3%.</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>The efficacy and the safety results show no observation of an increased risk for conversion of an AK into a SCC 2 years after a single 5‐ALA patch‐PDT. Additionally, the high clinical complete remission rate under routine conditions is comparable to the rates observed in the approval trials.</jats:p></jats:sec> |
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author | Reinhold, Uwe, Petering, Holger, Dirschka, Thomas, Rozsondai, András, Gille, Jens, Kurzen, Hjalmar, Ostendorf, Rolf, Ebeling, Andrea, Stocker, Marcus, Radny, Peter |
author_facet | Reinhold, Uwe, Petering, Holger, Dirschka, Thomas, Rozsondai, András, Gille, Jens, Kurzen, Hjalmar, Ostendorf, Rolf, Ebeling, Andrea, Stocker, Marcus, Radny, Peter, Reinhold, Uwe, Petering, Holger, Dirschka, Thomas, Rozsondai, András, Gille, Jens, Kurzen, Hjalmar, Ostendorf, Rolf, Ebeling, Andrea, Stocker, Marcus, Radny, Peter |
author_sort | reinhold, uwe |
container_issue | 12 |
container_start_page | 1399 |
container_title | Experimental Dermatology |
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description | <jats:title>Abstract</jats:title><jats:sec><jats:title>Background</jats:title><jats:p>It is important to collect data about the risk of transformation of an actinic keratosis (AK) lesion into squamous cell carcinoma (SCC) after a single photodynamic therapy (PDT) with 5‐ALA patch for a longer follow‐up period under daily routine.</jats:p></jats:sec><jats:sec><jats:title>Questions addressed</jats:title><jats:p>The purpose of this non‐interventional study (NIS) was to collect data on the frequency of occurrence of SCCs in the treated area during an interval of 2 years after a single 5‐ALA patch‐PDT.</jats:p></jats:sec><jats:sec><jats:title>Experimental design</jats:title><jats:p>This prospective observational case‐only study included patients with mild AK lesions on the head and face treated with 5‐ALA patch‐PDT according to the Summary of Product Characteristics (SPC).</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>In 370 patients, the risk of transformation of their treated AK lesion into SCC was 0.073% with its exact 95% confidence interval using the Poisson distribution of [0.009%, 0.262%]. The rate of complete clinical clearance on lesion basis after 3 months was 84.3%.</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>The efficacy and the safety results show no observation of an increased risk for conversion of an AK into a SCC 2 years after a single 5‐ALA patch‐PDT. Additionally, the high clinical complete remission rate under routine conditions is comparable to the rates observed in the approval trials.</jats:p></jats:sec> |
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spelling | Reinhold, Uwe Petering, Holger Dirschka, Thomas Rozsondai, András Gille, Jens Kurzen, Hjalmar Ostendorf, Rolf Ebeling, Andrea Stocker, Marcus Radny, Peter 0906-6705 1600-0625 Wiley Dermatology Molecular Biology Biochemistry http://dx.doi.org/10.1111/exd.13804 <jats:title>Abstract</jats:title><jats:sec><jats:title>Background</jats:title><jats:p>It is important to collect data about the risk of transformation of an actinic keratosis (AK) lesion into squamous cell carcinoma (SCC) after a single photodynamic therapy (PDT) with 5‐ALA patch for a longer follow‐up period under daily routine.</jats:p></jats:sec><jats:sec><jats:title>Questions addressed</jats:title><jats:p>The purpose of this non‐interventional study (NIS) was to collect data on the frequency of occurrence of SCCs in the treated area during an interval of 2 years after a single 5‐ALA patch‐PDT.</jats:p></jats:sec><jats:sec><jats:title>Experimental design</jats:title><jats:p>This prospective observational case‐only study included patients with mild AK lesions on the head and face treated with 5‐ALA patch‐PDT according to the Summary of Product Characteristics (SPC).</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>In 370 patients, the risk of transformation of their treated AK lesion into SCC was 0.073% with its exact 95% confidence interval using the Poisson distribution of [0.009%, 0.262%]. The rate of complete clinical clearance on lesion basis after 3 months was 84.3%.</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>The efficacy and the safety results show no observation of an increased risk for conversion of an AK into a SCC 2 years after a single 5‐ALA patch‐PDT. Additionally, the high clinical complete remission rate under routine conditions is comparable to the rates observed in the approval trials.</jats:p></jats:sec> Results of a multicentre non‐interventional study Photodynamic therapy with a 5‐ALA patch does not increase the risk of conversion of actinic keratoses into squamous cell carcinoma : Results of a multicentre non‐interventional study Experimental Dermatology |
spellingShingle | Reinhold, Uwe, Petering, Holger, Dirschka, Thomas, Rozsondai, András, Gille, Jens, Kurzen, Hjalmar, Ostendorf, Rolf, Ebeling, Andrea, Stocker, Marcus, Radny, Peter, Experimental Dermatology, Photodynamic therapy with a 5‐ALA patch does not increase the risk of conversion of actinic keratoses into squamous cell carcinoma : Results of a multicentre non‐interventional study, Dermatology, Molecular Biology, Biochemistry |
title | Photodynamic therapy with a 5‐ALA patch does not increase the risk of conversion of actinic keratoses into squamous cell carcinoma : Results of a multicentre non‐interventional study |
title_full | Photodynamic therapy with a 5‐ALA patch does not increase the risk of conversion of actinic keratoses into squamous cell carcinoma : Results of a multicentre non‐interventional study |
title_fullStr | Photodynamic therapy with a 5‐ALA patch does not increase the risk of conversion of actinic keratoses into squamous cell carcinoma : Results of a multicentre non‐interventional study |
title_full_unstemmed | Photodynamic therapy with a 5‐ALA patch does not increase the risk of conversion of actinic keratoses into squamous cell carcinoma : Results of a multicentre non‐interventional study |
title_short | Photodynamic therapy with a 5‐ALA patch does not increase the risk of conversion of actinic keratoses into squamous cell carcinoma : Results of a multicentre non‐interventional study |
title_sort | photodynamic therapy with a 5‐ala patch does not increase the risk of conversion of actinic keratoses into squamous cell carcinoma : results of a multicentre non‐interventional study |
title_sub | Results of a multicentre non‐interventional study |
title_unstemmed | Photodynamic therapy with a 5‐ALA patch does not increase the risk of conversion of actinic keratoses into squamous cell carcinoma : Results of a multicentre non‐interventional study |
topic | Dermatology, Molecular Biology, Biochemistry |
url | http://dx.doi.org/10.1111/exd.13804 |