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Évaluation de dispositifs d’illumination textiles permettant d’améliorer l’efficacité et la tolérance de la Thérapie Photodynamique en Dermatologie : modèle des kératoses actiniques

Abstract : Background: Photodynamic therapy is an effective treatment for actinic keratosis, for patients with large areas of field cancerization. Among the approved protocols in Europe, the most widely used requires illumination with a LED lamp. However, pain during irradiation and the reproductibility are two limiting factors of this protocol. To overcome these limits, a light-emitting fabric-based device was developed. We evaluated these devices and two illumination schemes: Flexitheraligth at a fluence rate of 12.3 mW/cm2 to get a fluence of 37J/cm2 and Pho-Istos at a fluence rate of 1.3 mW/cm2 to get a fluence of 12J/cm2.Objectives: We aim to assess the non-inferiority, in terms of photodynamic therapy efficacy to treat actinic keratosis, of the Flexitheralight and Phos-Istos devices compared with the conventional protocol using the red LED lamp.Methods: Randomized, controlled, phase II clinical studies were performed. We included patients with grade I-II actinic keratosis of the forehead and scalp, treated with methyl aminolevulinate photodynamic therapy in two symmetrical areas. One area was treated with the conventional protocol, whereas the other area was treated with the Flexitheralight or the Phos-Istos protocol, depending on the study. The primary endpoint was the lesion complete response rate at three months (an absolute non-inferiority margin of -10% was used). The secondary endpoints included patient-reported pain at the end of the irradiation.Results: The Flexitheralight study included twenty-five patients treated with the Flexitheralight device on one area (n=154 actinic keratosis) and with the LED lamp on the contralateral area (n=156 actinic keratosis). The lesion complete response rate with the Flexitheralight protocol was non-inferior to that obtained with the LED lamp (66.0% vs. 59.1%, respectively; absolute difference, 6.9%; 95% confidence interval, -0.6% to 14.5%). Patient-reported pain was significantly lower with the Flexitheralight protocol than with the LED lamp (mean ± standard deviation: 0.4 ± 0.6 vs. 5.0 ± 2.6; p<0.0001).The Phos-Istos study included forty-six patients treated with the Phos-Istos device on one area (n=280 lesions) and with the LED lamp on the contralateral area (n=280 lesions). Three months following treatment, the lesion complete response rate of the Phos-Istos device was non-inferior to the LED lamp (79.3% vs. 80.7%, respectively; absolute difference, -1.6%; one-sided 95% confidence interval, -4.5% to infinity). The pain score at the end of illumination was significantly lower for the Phos-Istos device than for the LED lamp (mean±standard deviation: 0.3±0.6 vs. 7.4±2.3; p<0.0001).Conclusions: The light emitting fabrics and the low-irradiance protocols are non-inferior in terms of efficacy and superior in terms of tolerability to the conventional protocol for treating actinic keratoses of the forehead and scalp.
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Claire Vicentini. Évaluation de dispositifs d’illumination textiles permettant d’améliorer l’efficacité et la tolérance de la Thérapie Photodynamique en Dermatologie : modèle des kératoses actiniques. Médecine humaine et pathologie. Université du Droit et de la Santé - Lille II, 2019. Français. ⟨NNT : 2019LIL2S044⟩. ⟨tel-02920031⟩

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