A New Light-Emitting, Fabric-Based Device for Photodynamic Therapy of Actinic Keratosis: Protocol for a Randomized, Controlled, Multicenter, Intra-Individual, Phase II Noninferiority Study (the Phosistos Study)

Vignion‐Dewalle, Anne‐Sophie; Rached, Henry Abi; Thecua, Elise; Lecomte, F.; Deleporte, Pascal; Behal, Hélène; Hommel, Theresa; Duhamel, Alain; Szeimies, Rolf‐Markus; Mortier, Laurent; Mordon, Serge

doi:10.2196/12990

Cited by 9 publications

(11 citation statements)

References 31 publications

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“…This device was classified as exempt risk group according to IEC 60601-2-57/ 2012. [24] For this clinical protocol, 47 patients were included in the study. C-PDT was performed as usual with an LED panel, 3 hours after MAL application with 75 mW/cm 2 for 10 minutes.…”

Section: Evaluating Illumination Of Actinic Keratosis With An Helmementioning

confidence: 99%

“…Each one is illuminated sequentially with a 635 nm laser at low fluence rate (12.3 mW/cm 2 ) for 1 minute, such as a fractionated irradiation (1 minute light, 2 minutes dark) is achieved (Figure 11). An irradiation time of two and a half hours enables to deliver a total light dose of about 37 J/cm 2 anywhere in the treated area (12.3 mW/cm 2 × 9000 seconds × 1 minute light/[1 minute light + 2 minutes dark]) [24].…”

Section: Clinical Study #1: Evaluating Illumination Of Actinic Keratomentioning

confidence: 99%

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Light emitting fabrics for photodynamic therapy: Technology, experimental and clinical applications

Mordon

Thecua

Ziane

et al. 2020

Transl Biophotonics

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A homogeneous and reproducible fluence rate delivery during clinical photodynamic therapy (PDT) plays a determinant role in preventing under-or overtreatment. The development of a flexible light source able to generate uniform light on all its surface would considerably improve the homogeneity of light delivery. The integration of plastic optical fibers into textile structures offers an interesting alternative. This article aims to describe briefly the technology used to develop light emitting fabrics (LEF) and their use in vitro (CELL-LEF), in vivo (VIVO-LEF) for experimental evaluation of PDT. Finally, the use of LEF for clinical applications is given by three examples. For in vitro applications, the CELL-LEF device allows the illumination of several 96-well cell culture plates. For the VIVO-LEF, the system developed for PDT can treat three mice simultaneously with a homogeneous and high irradiance The medical LEF systems developed for PDT in dermatology for the treatment of actinic keratosis demonstrate their superiority thanks to a uniform light distribution due the flexibility of LEF. Interestingly, the technology used for manufacturing LEF is very well known by the textile industry, leading to very competitive production costs. The fact that optical fibers can transmit light from 400 to 1200 nm allows the connection of LEF to different laser sources covering the light spectrum of all photosensitizers used for medical applications. New developments should allow to use the LEF inside cavities such as the pleural or the peritoneal cavities.

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Section: Evaluating Illumination Of Actinic Keratosis With An Helmementioning

confidence: 99%

Section: Clinical Study #1: Evaluating Illumination Of Actinic Keratomentioning

confidence: 99%

Light emitting fabrics for photodynamic therapy: Technology, experimental and clinical applications

Mordon

Thecua

Ziane

et al. 2020

Transl Biophotonics

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“…The development of such technology, incorporating optical fibers into a flexible structure that emits fractional light, appears to provide a therapeutic solution for nonplanar anatomical surfaces such as curved surfaces and body extremities. A PDT device incorporating light-emitting fabrics (LEFs) is in use in several clinical studies [11-13] run by the Lille University Hospital for the treatment of actinic keratoses, and the first results seem to be promising, particularly with regard to the pain felt by patients.…”

Section: Introductionmentioning

confidence: 99%

Photodynamic Therapy Using a New Painless Light-Emitting Fabrics Device in the Treatment of Extramammary Paget Disease of the Vulva (the PAGETEX Study): Protocol for an Interventional Efficacy and Safety Trial

Lecomte¹,

Thecua²,

Ziane³

et al. 2019

JMIR Res Protoc

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BackgroundExtramammary Paget disease of the vulva (EMPV) is a rare skin disorder commonly seen in postmenopausal Caucasian females that appears clinically as red, eczematous, pruriginous, and sometimes painful lesions. Although most cases are noninvasive, EMPV may be associated with an underlying or distant adenocarcinoma. EMPV has a chronic and relapsing course. The reference treatment is based on local surgical excision with negative margins. However, disease frequently extends far from the visible lesion, and surgical margins are frequently positive. Topical photodynamic therapy (PDT) is an established treatment modality for various dermatooncologic conditions. For example, red light irradiation with the Aktilite CL 128 and Metvixia (Galderma SA) as a photosensitizing molecule is a conventional protocol approved and widely used in Europe for PDT treatment of actinic keratosis, but this treatment is not yet widely used for EMPV because it has never clearly been demonstrated and is very painful.ObjectiveThe aim of the study is to investigate the efficacy and safety relating to the medical device PAGETEX as a new painless PDT device using Metvixia in the treatment of vulvar Paget disease. The primary end point is the disease control rate at 3 months in 30% of the patients included, defined as stability, partial response, or total response, considering the extent of the lesion. Secondary end points are the disease control rate at 6 months, patient quality of life, level of pain experienced by the patient at each PDT session, severity of erythema, presence of protoporphyrin IX in Paget cells after each PDT session, and overall satisfaction level of the patient.MethodsThe trial is an interventional, exploratory, simple group, nonrandomized, and single center (Lille University Hospital) study. Twenty-four patients will be included according to Simon’s optimal plan. Therapeutic procedure is based on a cycle of two PDT sessions with the PAGETEX medical device at 15-day intervals (Metvixia incubation during 30 minutes and 635 nm red light illumination with a low irradiance for 2 hours and 30 minutes for a total fluence of 12 J/cm²). At the assessment session, 3 months after inclusion, if the control of the disease is partial or null, the patient will complete another cycle of two PDT sessions. A final evaluation will be performed in all patients at 6 months. Analyses will be performed using SAS version 9.4 software (SAS Institute Inc). The characteristics of the patients at baseline will be described; qualitative variables will be described by numbers and percentages, and quantitative variables will be described either by the mean and standard deviation for Gaussian distribution or by the median and interquartile range (ie, 25th and 75th percentiles). The normality of the distributions will be tested by a Shapiro-Wilk test and checked graphically by histograms.ResultsFirst patient was included in September 2019 and clinical investigations are planned until August 2022. The final results of this study are expected to be a...

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“…To date, none of them can be considered as a solid alternative to surgical excision yet [3]. Nonetheless, multiple clinical cases suggest that PDT could provide the opportunity to treat subclinical lesions, and give some relief on patient's symptoms of the disease [4][5][6].Unfortunately, the benefits of using photodynamic therapy for vulvar EMPD remains a challenge to demonstrate, because of the inhomogeneous illumination of vulvar and perianal areas, and the extreme pain that patients usually experienced during the illumination procedure that may lead to premature end of treatment [7,8].Resulting from the knowledge of previous works on actinic keratosis of the scalp treatment with PDT, light emitting fabrics (LEF) technology could address both of the hereinbefore described issues [9][10][11][12]. A new medical device based on LEF named PAGETEX® dedicated to illumination of vulvar and perianal areas has been developed.…”

mentioning

confidence: 99%

“…Resulting from the knowledge of previous works on actinic keratosis of the scalp treatment with PDT, light emitting fabrics (LEF) technology could address both of the hereinbefore described issues [9][10][11][12]. A new medical device based on LEF named PAGETEX® dedicated to illumination of vulvar and perianal areas has been developed.…”

mentioning

confidence: 99%

Light emitting fabrics for photodynamic treatment of vulvar primary extramammary Paget's disease

Thecua

Lecomte

Ziane

et al. 2019

17th International Photodynamic Association World Congress

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Primary Extramammary Paget's disease (EMPD) is a rare cancer that mainly affects the genital region including vulvar and perianal areas.Without treatment, vulvar EMPD progresses and presents always more erythematous and pruritic plaques, which may become ulcerated and erosive. To control disease progression and symptoms usually experienced by patients, surgical excision is the mainstay of treatment. Unfortunately, even after large surgical excision with intra-operative margin control, recurrences are common [1]. For recurrent patients which undergo multiple resections, severe functional and sexual alterations are described.Only few data are available on the efficacy of alternative conservative treatments, such as laser ablation, radiotherapy, topical chemotherapy and photodynamic therapy (PDT) [2]. To date, none of them can be considered as a solid alternative to surgical excision yet [3]. Nonetheless, multiple clinical cases suggest that PDT could provide the opportunity to treat subclinical lesions, and give some relief on patient's symptoms of the disease [4][5][6].Unfortunately, the benefits of using photodynamic therapy for vulvar EMPD remains a challenge to demonstrate, because of the inhomogeneous illumination of vulvar and perianal areas, and the extreme pain that patients usually experienced during the illumination procedure that may lead to premature end of treatment [7,8].Resulting from the knowledge of previous works on actinic keratosis of the scalp treatment with PDT, light emitting fabrics (LEF) technology could address both of the hereinbefore described issues [9][10][11][12]. A new medical device based on LEF named PAGETEX® dedicated to illumination of vulvar and perianal areas has been developed. The device delivers a homogeneous red light (635 nm) with a low irradiance during 2h30, for a total fluence of 12 J/cm². The PAGETEX® device is being assessed in a clinical study (NCT03713203) which aims to establish PAGETEX®-PDT efficacy and tolerability.

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A New Light-Emitting, Fabric-Based Device for Photodynamic Therapy of Actinic Keratosis: Protocol for a Randomized, Controlled, Multicenter, Intra-Individual, Phase II Noninferiority Study (the Phosistos Study)

Cited by 9 publications

References 31 publications

Light emitting fabrics for photodynamic therapy: Technology, experimental and clinical applications

Light emitting fabrics for photodynamic therapy: Technology, experimental and clinical applications

Photodynamic Therapy Using a New Painless Light-Emitting Fabrics Device in the Treatment of Extramammary Paget Disease of the Vulva (the PAGETEX Study): Protocol for an Interventional Efficacy and Safety Trial

Light emitting fabrics for photodynamic treatment of vulvar primary extramammary Paget's disease

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