TY  - JOUR
DA  - 2018/10/26
AU  - Vicentini, C.
AU  - Vignion-Dewalle, Anne-Sophie
AU  - Thecua, Elise
AU  - Lecomte, Fabienne
AU  - Maire, Cyril
AU  - Deleporte, P.
AU  - Behal, Helene
AU  - Kerob, D.
AU  - Duhamel, Alain
AU  - Mordon, Serge
AU  - Mortier, Laurent
TI  - Photodynamic therapy for actinic keratosis of the forehead and scalp: a randomized, controlled, phase ii clinical study evaluating the non-inferiority of a new protocol involving irradiation with a light-emitting, fabric-based device (the flexitheralight protocol) compared with the conventional protocol involving irradiation with the aktilite cl 128 lamp
DO  - 10.1111/bjd.17350
JA  - Br. J. Dermatol.
LA  - Anglais
UR  - http://hdl.handle.net/20.500.12210/16877
SN  - 1365-2133
AB  - Photodynamic therapy (PDT) is an effective treatment for actinic keratosis (AK), particularly for patients with large areas of field cancerization. Among the approved protocols in Europe, the most widely used requires irradiation with the Aktilite CL 128 lamp. However, pain during irradiation and the suboptimal adaptability of the lamp relative to the treatment area are two limiting factors of this protocol. To overcome these limits, a new protocol (referred to as the Flexitheralight protocol) involving irradiation with a light-emitting, fabric-based device was developed.This paper aims to assess the noninferiority, in terms of PDT efficacy for treating AK, of the Flexitheralight protocol compared with the conventional protocol, which requires irradiation with the Aktilite CL 128 lamp.A monocentric, randomized, controlled, phase II clinical study was performed. Twenty-five patients with grade I-II AKs of the forehead and scalp were treated with methyl aminolaevulinate PDT in two symmetrical areas. One area was treated with the conventional protocol (n = 154 AKs), whereas the other area was treated with the Flexitheralight protocol (n = 156 AKs). The primary end-point was the lesion complete response (CR) rate at 3 months (an absolute noninferiority margin of -10% was used). The secondary end-points included patient-reported pain at the end of the irradiation.At 3 months, the lesion CR rate with the Flexitheralight protocol was noninferior to that obtained with the conventional protocol (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 conventional protocol (mean ± SD: 0·4 ± 0·6 vs. 5·0 ± 2·6; P < 0·0001).The Flexitheralight protocol is noninferior in terms of efficacy and superior in terms of tolerability to the conventional protocol for treating AKs of the forehead and scalp.
JO  - The British journal of dermatology
ER  - 
TY  - JOUR
DA  - 2020/01/01
VL  - 182
IS  - 1
SP  - 76
EP  - 84
AU  - Mordon, Serge
AU  - Vignion-Dewalle, Anne-Sophie
AU  - Abi-Rached, H.
AU  - Thecua, Elise
AU  - Lecomte, Fabienne
AU  - Vicentini, C.
AU  - Deleporte, P.
AU  - Behal, Helene
AU  - Kerob, D.
AU  - Hommel, T.
AU  - Duhamel, Alain
AU  - Szeimies, R M.
AU  - Mortier, Laurent
TI  - The conventional protocol versus a protocol including illumination with a fabric-based biophotonic device (the phosistos protocol) in photodynamic therapy for actinic keratosis: a randomized, controlled, non-inferiority clinical study
DO  - 10.1111/bjd.18048
JA  - Br. J. Dermatol.
LA  - Anglais
UR  - http://hdl.handle.net/20.500.12210/16878
SN  - 1365-2133
AB  - Topical photodynamic therapy (PDT) using methyl aminolaevulinate is a noninvasive treatment option suitable to treat clinical and subclinical actinic keratosis (AK) over a large area (field cancerization). The most widely used, conventional protocol in Europe includes illumination with a red-light lamp. This illumination commonly causes pain, and patients often cannot complete the treatment.OBJECTIVE: The aims of this paper are twofold. The first aim is to introduce a novel protocol, the Phosistos protocol (P-PDT), which includes illumination with a fabric-based biophotonic device. The second and major aim is to assess the noninferiority, in terms of efficacy for PDT of AK, of P-PDT compared with the conventional protocol (C-PDT).METHODS: A randomized, controlled, multicentre, intraindividual clinical study was conducted. Forty-six patients with grade I-II AK of the forehead and scalp were treated with P-PDT on one area (280 AK lesions) and with C-PDT on the contralateral area (280 AK lesions). The primary end point was the lesion complete response (CR) rate at 3 months, with an absolute noninferiority margin of -10%. Secondary end points included pain scores, incidence of adverse effects and cosmetic outcome.RESULTS: Three months following treatment, the lesion CR rate of P-PDT was noninferior to that of C-PDT (79·3% vs. 80·7%, respectively; absolute difference -1·6%; one-sided 95% confidence interval -4·5% to infinity). The noninferiority of P-PDT to C-PDT in terms of the lesion CR rate remained at the 6-month follow-up (94·2% vs. 94·9%, respectively; absolute difference -0·6%; one-sided 95% confidence interval -2·7% to infinity). Moreover, the pain score at the end of illumination was significantly lower for P-PDT than for C-PDT (mean ± SD 0·3 ± 0·6 vs. 7·4 ± 2·3; P < 0·001).CONCLUSIONS: P-PDT is noninferior to C-PDT in terms of efficacy for treating AK of the forehead and scalp and resulted in much lower pain scores and fewer adverse effects.
PB  - Oxford Academic
JO  - The British journal of dermatology
ER  - 
