Randomized controlled trial for evaluation of efficacy and pain during photodynamic therapy for actinic keratosis of face and scalp comparing two irradiation protocols
Autor(a) principal: | |
---|---|
Data de Publicação: | 2022 |
Outros Autores: | , , , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Institucional da UNESP |
Texto Completo: | http://dx.doi.org/10.1016/j.pdpdt.2021.102623 http://hdl.handle.net/11449/230074 |
Resumo: | Background: Pain is a frequent adverse event during photodynamic therapy, which can limit treatment acceptance. This study aimed to evaluate the efficacy and pain during photodynamic therapy with two irradiation protocols in patients with actinic keratosis on the face and scalp. Methods: In this intra-patient randomized controlled trial, participants were randomly allocated to receive photodynamic therapy with methyl aminolevulinate and red light on the right or left side with protocol 1 (irradiation device in contact with the skin) and protocol 2 (device 3 cm away from the skin). There was a 15-day interval between the protocols. The primary outcome was the frequency of mean intensity of moderate or severe pain during photodynamic therapy. Secondary outcomes were actinic keratosis clearance rate, protoporphyrin IX consumption, participant preference, skin appearance, and adverse events. Results: Forty-one participants were included, yielding 47 and 50 randomized sites for protocols 1 and 2. There was no difference in the frequency of moderate and severe pain, with a relative risk of 1.09 (95% CI 0.70–1.70), p>0.05. An actinic keratosis count reduction >60% was observed in both protocols (p<0.01), with no difference between them. There was no difference in protoporphyrin IX consumption. Most treated sites were of good to excellent quality. There was a greater patient preference for protocol 2 (p<0.01). Conclusions: The pain intensity was similar between the protocols, and the protocols were equally effective for actinic keratosis clearance, protoporphyrin IX consumption, and improvement in the quality of the treated areas. Both protocols may be considered safe. |
id |
UNSP_b6ae9b08ab02a62481804658026861bc |
---|---|
oai_identifier_str |
oai:repositorio.unesp.br:11449/230074 |
network_acronym_str |
UNSP |
network_name_str |
Repositório Institucional da UNESP |
repository_id_str |
2946 |
spelling |
Randomized controlled trial for evaluation of efficacy and pain during photodynamic therapy for actinic keratosis of face and scalp comparing two irradiation protocolsKeratosis actinicPainPhotochemotherapyPhotodynamic TherapyRandomized controlled trialBackground: Pain is a frequent adverse event during photodynamic therapy, which can limit treatment acceptance. This study aimed to evaluate the efficacy and pain during photodynamic therapy with two irradiation protocols in patients with actinic keratosis on the face and scalp. Methods: In this intra-patient randomized controlled trial, participants were randomly allocated to receive photodynamic therapy with methyl aminolevulinate and red light on the right or left side with protocol 1 (irradiation device in contact with the skin) and protocol 2 (device 3 cm away from the skin). There was a 15-day interval between the protocols. The primary outcome was the frequency of mean intensity of moderate or severe pain during photodynamic therapy. Secondary outcomes were actinic keratosis clearance rate, protoporphyrin IX consumption, participant preference, skin appearance, and adverse events. Results: Forty-one participants were included, yielding 47 and 50 randomized sites for protocols 1 and 2. There was no difference in the frequency of moderate and severe pain, with a relative risk of 1.09 (95% CI 0.70–1.70), p>0.05. An actinic keratosis count reduction >60% was observed in both protocols (p<0.01), with no difference between them. There was no difference in protoporphyrin IX consumption. Most treated sites were of good to excellent quality. There was a greater patient preference for protocol 2 (p<0.01). Conclusions: The pain intensity was similar between the protocols, and the protocols were equally effective for actinic keratosis clearance, protoporphyrin IX consumption, and improvement in the quality of the treated areas. Both protocols may be considered safe.Skin Department of Amaral Carvalho HospitalDepartment of Infectology Dermatology Imaging Diagnosis and Radiotherapy Botucatu Medical School (FMB) São Paulo State University (UNESP)Sao Carlos Institute of Physics University of Sao PauloDepartment of Infectology Dermatology Imaging Diagnosis and Radiotherapy Botucatu Medical School (FMB) São Paulo State University (UNESP)Skin Department of Amaral Carvalho HospitalUniversidade Estadual Paulista (UNESP)Universidade de São Paulo (USP)ER, OliveiraAG, SalvioHA, Miot [UNESP]MB, Requena [UNESP]MMC, MedeirosMR, GarciaLPF, Abbade [UNESP]2022-04-29T08:37:32Z2022-04-29T08:37:32Z2022-03-01info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articlehttp://dx.doi.org/10.1016/j.pdpdt.2021.102623Photodiagnosis and Photodynamic Therapy, v. 37.1873-15971572-1000http://hdl.handle.net/11449/23007410.1016/j.pdpdt.2021.1026232-s2.0-85121312621Scopusreponame:Repositório Institucional da UNESPinstname:Universidade Estadual Paulista (UNESP)instacron:UNESPengPhotodiagnosis and Photodynamic Therapyinfo:eu-repo/semantics/openAccess2022-04-29T08:37:32Zoai:repositorio.unesp.br:11449/230074Repositório InstitucionalPUBhttp://repositorio.unesp.br/oai/requestopendoar:29462022-04-29T08:37:32Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP)false |
dc.title.none.fl_str_mv |
Randomized controlled trial for evaluation of efficacy and pain during photodynamic therapy for actinic keratosis of face and scalp comparing two irradiation protocols |
title |
Randomized controlled trial for evaluation of efficacy and pain during photodynamic therapy for actinic keratosis of face and scalp comparing two irradiation protocols |
spellingShingle |
Randomized controlled trial for evaluation of efficacy and pain during photodynamic therapy for actinic keratosis of face and scalp comparing two irradiation protocols ER, Oliveira Keratosis actinic Pain Photochemotherapy Photodynamic Therapy Randomized controlled trial |
title_short |
Randomized controlled trial for evaluation of efficacy and pain during photodynamic therapy for actinic keratosis of face and scalp comparing two irradiation protocols |
title_full |
Randomized controlled trial for evaluation of efficacy and pain during photodynamic therapy for actinic keratosis of face and scalp comparing two irradiation protocols |
title_fullStr |
Randomized controlled trial for evaluation of efficacy and pain during photodynamic therapy for actinic keratosis of face and scalp comparing two irradiation protocols |
title_full_unstemmed |
Randomized controlled trial for evaluation of efficacy and pain during photodynamic therapy for actinic keratosis of face and scalp comparing two irradiation protocols |
title_sort |
Randomized controlled trial for evaluation of efficacy and pain during photodynamic therapy for actinic keratosis of face and scalp comparing two irradiation protocols |
author |
ER, Oliveira |
author_facet |
ER, Oliveira AG, Salvio HA, Miot [UNESP] MB, Requena [UNESP] MMC, Medeiros MR, Garcia LPF, Abbade [UNESP] |
author_role |
author |
author2 |
AG, Salvio HA, Miot [UNESP] MB, Requena [UNESP] MMC, Medeiros MR, Garcia LPF, Abbade [UNESP] |
author2_role |
author author author author author author |
dc.contributor.none.fl_str_mv |
Skin Department of Amaral Carvalho Hospital Universidade Estadual Paulista (UNESP) Universidade de São Paulo (USP) |
dc.contributor.author.fl_str_mv |
ER, Oliveira AG, Salvio HA, Miot [UNESP] MB, Requena [UNESP] MMC, Medeiros MR, Garcia LPF, Abbade [UNESP] |
dc.subject.por.fl_str_mv |
Keratosis actinic Pain Photochemotherapy Photodynamic Therapy Randomized controlled trial |
topic |
Keratosis actinic Pain Photochemotherapy Photodynamic Therapy Randomized controlled trial |
description |
Background: Pain is a frequent adverse event during photodynamic therapy, which can limit treatment acceptance. This study aimed to evaluate the efficacy and pain during photodynamic therapy with two irradiation protocols in patients with actinic keratosis on the face and scalp. Methods: In this intra-patient randomized controlled trial, participants were randomly allocated to receive photodynamic therapy with methyl aminolevulinate and red light on the right or left side with protocol 1 (irradiation device in contact with the skin) and protocol 2 (device 3 cm away from the skin). There was a 15-day interval between the protocols. The primary outcome was the frequency of mean intensity of moderate or severe pain during photodynamic therapy. Secondary outcomes were actinic keratosis clearance rate, protoporphyrin IX consumption, participant preference, skin appearance, and adverse events. Results: Forty-one participants were included, yielding 47 and 50 randomized sites for protocols 1 and 2. There was no difference in the frequency of moderate and severe pain, with a relative risk of 1.09 (95% CI 0.70–1.70), p>0.05. An actinic keratosis count reduction >60% was observed in both protocols (p<0.01), with no difference between them. There was no difference in protoporphyrin IX consumption. Most treated sites were of good to excellent quality. There was a greater patient preference for protocol 2 (p<0.01). Conclusions: The pain intensity was similar between the protocols, and the protocols were equally effective for actinic keratosis clearance, protoporphyrin IX consumption, and improvement in the quality of the treated areas. Both protocols may be considered safe. |
publishDate |
2022 |
dc.date.none.fl_str_mv |
2022-04-29T08:37:32Z 2022-04-29T08:37:32Z 2022-03-01 |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
http://dx.doi.org/10.1016/j.pdpdt.2021.102623 Photodiagnosis and Photodynamic Therapy, v. 37. 1873-1597 1572-1000 http://hdl.handle.net/11449/230074 10.1016/j.pdpdt.2021.102623 2-s2.0-85121312621 |
url |
http://dx.doi.org/10.1016/j.pdpdt.2021.102623 http://hdl.handle.net/11449/230074 |
identifier_str_mv |
Photodiagnosis and Photodynamic Therapy, v. 37. 1873-1597 1572-1000 10.1016/j.pdpdt.2021.102623 2-s2.0-85121312621 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
Photodiagnosis and Photodynamic Therapy |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.source.none.fl_str_mv |
Scopus reponame:Repositório Institucional da UNESP instname:Universidade Estadual Paulista (UNESP) instacron:UNESP |
instname_str |
Universidade Estadual Paulista (UNESP) |
instacron_str |
UNESP |
institution |
UNESP |
reponame_str |
Repositório Institucional da UNESP |
collection |
Repositório Institucional da UNESP |
repository.name.fl_str_mv |
Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP) |
repository.mail.fl_str_mv |
|
_version_ |
1792961886693621760 |