Objectives: Topical photodynamic therapy using methyl aminolevulinate is a non-invasive treatment option suitable to treat clinical and subclinical actinic keratosis (AK) over a large area (field cancerization). The illumination commonly causes pain, and very often patients cannot complete the treatment.
Introduction: This study aims i) to introduce a novel protocol, so-called the Phosistos protocol (P-PDT), which includes irradiation with a fabric-based biophotonic device, ii) to assess the non-inferiority, in terms of efficacy for PDT of AK , of the P-PDT compared to the conventional protocol (C-PDT).
Materials / method: A randomized, controlled, multicentre, intra-individual clinical study was conducted. Forty-six patients with grade I-II actinic keratosis of the forehead and scalp were treated with the P-PDT on one area (n=280 actinic keratosis) and with the C-PDT on the contralateral area (n=280 actinic keratosis). The primary endpoint was the lesion complete response rate at three months with an absolute non-inferiority margin of -10%. Secondary endpoints included patient-reported pain scores, emergence of new actinic keratosis, incidence of adverse events and cosmetic outcome.
Results: Three months following treatment, the lesion complete response rate with the P-PDT was non-inferior to the C-PDT (79.3% vs. 80.7%, respectively) Moreover, the patient-reported pain score was significantly lower with the P-PDT compared to the C-PDT(mean ± standard deviation: 0.3 ± 0.6 vs. 7.4 ± 2.3; p<0.0001). At six months, there was a lower incidence of new actinic keratosis for the area treated by the P-PDT compared to the C-PDT(8.6%).of patients vs. 39.1%
Conclusion: The Phosistos protocol (P-PDT) is non-inferior in terms of efficacy than the conventional protocol (C-PDT)in treating actinic keratosis of the forehead and scalp while leading to much lower pain scores and fewer adverse events.
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Укажите, пожалуйста, лица (индивидуальное, предприятие, организация): The Phosistos project was funded by the European Commission under the Competitiveness and Innovation Framework Programme (CIP) (Project identifier: CIP-ICT-PSP-2013-7-621103).
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