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Home- vs clinic-based daylight photodynamic therapy with 5-aminolevulinic acid nanoemulsion (BF-200 ALA) for actinic keratosis: A randomized, single-blind, prospective study.
Saenz-Guirado, S; Ayen-Rodriguez, A; Galvez-Moreno, M; Velasco-Amador, J P; Llamas-Molina, J M; Ruiz-Villaverde, R; Molina-Leyva, A.
Afiliação
  • Saenz-Guirado S; Department of Dermatology, University Hospital San Cecilio, Granada, Spain. Electronic address: ssguirado@gmail.com.
  • Ayen-Rodriguez A; Department of Dermatology, University Hospital San Cecilio, Granada, Spain.
  • Galvez-Moreno M; Department of Dermatology, University Hospital San Cecilio, Granada, Spain.
  • Velasco-Amador JP; Department of Dermatology, University Hospital San Cecilio, Granada, Spain.
  • Llamas-Molina JM; Department of Dermatology, University Hospital San Cecilio, Granada, Spain.
  • Ruiz-Villaverde R; Department of Dermatology, University Hospital San Cecilio, Granada, Spain; Biosanitary Institute of Granada, IBS, Granada, Spain.
  • Molina-Leyva A; Biosanitary Institute of Granada, IBS, Granada, Spain; Department of Dermatology, University Hospital Virgen de las Nieves, Granada. Spain; Facultad de Medicina. Universidad de Granada, Spain.
Photodiagnosis Photodyn Ther ; 46: 104031, 2024 Apr.
Article em En | MEDLINE | ID: mdl-38438001
ABSTRACT

BACKGROUND:

Daylight photodynamic therapy (DL-PDT) has become one of the most effective treatments for the resolution of actinic keratosis (AK) of Olsen grade 1 and 2. Generally, PDT it is carried out in a clinic setting, which involves the patient's and their caregivers commuting to the hospital as well as a significant use of resources to carry it out within the clinic setting.

OBJECTIVES:

To determine the efficacy and safety of a home-based treatment of AK with DL-PDT with the BF-200 ALA gel compared to a clinic-based setting.

METHODS:

The study was performed as a randomized, single-center, non-inferiority clinical trial with two parallel groups. 9 patients received one clinic-based DL-PDT (group 1) and 11 patients received one session of home-based DL-PDT (group 2). The primary endpoints were the mean AK clearance per patient and the total AK lesion clearance rate 12 weeks after treatment. The secondary endpoints were the number of remaining AKs and new AKs appearing in the treatment field 12 weeks after one PDT session. The pain during and 24 h after PDT as well as the local skin reactions were also assessed.

RESULTS:

The overall reduction of AK lesions per patient was similar in both groups with one PDT session. An overall AK clearance per patient of 10 ± 4.33 for group 1 versus 9.73 ± 2.9 for group 2 without statistically significant differences (p = 0.868). Regarding the clearance rate, although it was slightly higher in group 2 (71.58 ± 22.51 vs 82.1 ± 11.13), the analysis did not show statistically significant differences. The mild pain recorded during the treatment course and the mild local skin reactions were similar in both groups. Patient satisfaction was high for both groups without statistically significant differences.

CONCLUSION:

Self-performed home-based DL-PDT with BF-200 ALA gel is as effective as the one performed in a clinic-based setting, with a comparable safety profile, high levels of patient satisfaction and with advantages for the patients and their caregivers that can enhance patient´s adherence to the treatment.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Fotoquimioterapia / Fármacos Fotossensibilizantes / Ceratose Actínica / Ácido Aminolevulínico Limite: Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: Photodiagnosis Photodyn Ther / Photodiagnosis and photodynamic therapy / Photodiagnosis photodyn. ther Assunto da revista: DIAGNOSTICO POR IMAGEM / TERAPEUTICA Ano de publicação: 2024 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Fotoquimioterapia / Fármacos Fotossensibilizantes / Ceratose Actínica / Ácido Aminolevulínico Limite: Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: Photodiagnosis Photodyn Ther / Photodiagnosis and photodynamic therapy / Photodiagnosis photodyn. ther Assunto da revista: DIAGNOSTICO POR IMAGEM / TERAPEUTICA Ano de publicação: 2024 Tipo de documento: Article
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