Title :

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

Author(s) :

Mordon, Serge [Auteur]
Thérapies Lasers Assistées par l'Image pour l'Oncologie (ONCO-THAI) - U1189
Vignion-Dewalle, Anne-Sophie [Auteur]
Abi-Rached, H. [Auteur]
Thecua, E. [Auteur]
Lecomte, F. [Auteur]
Vicentini, C. [Auteur]
Deleporte, P. [Auteur]
Behal, Helene [Auteur]
METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694
Kerob, D. [Auteur]
Hommel, T. [Auteur]
Duhamel, Alain [Auteur]
METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694
Szeimies, R M. [Auteur]
Mortier, L. [Auteur]

Journal title :

The British journal of dermatology

Abbreviated title :

Br. J. Dermatol.

Publication date :

2019-04-25

ISSN :

1365-2133

HAL domain(s) :

Sciences du Vivant [q-bio]

English abstract : [en]

BACKGROUND: 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 ...
Show more >BACKGROUND: 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.Show less >

Language :

Anglais

Audience :

Internationale

Popular science :

Non

Administrative institution(s) :

CHU Lille
Inserm
Université de Lille

Collections :

• METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694
• Thérapies Lasers Assistées par l'Image pour l'Oncologie (ONCO-THAI) - U1189

Submission date :

2019-12-09T16:50:11Z