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 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
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series Experimental Dermatology
source_id 49
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
container_volume 27
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