Light-emitting fabrics for dermatological diseases

Customer case

Research by: Laser-assisted therapies and immunotherapies for oncology (OncoThAI) center at University of Lille is a large research center that carries fundamental and translational projects with aim to widely implement PDT to clinical use either alone or in combination with other therapies like surgery or immunotherapy.

Modulight products: ML7710 (631, 635, 665 nm)

Laser use: Light-emitting fabrics for PDT therapy at clinical level

 

Prof. Serge Mordon PhD, currently at BioTis/Inserm

 

 


Dr. Laurent Mortier, MD, PhD, University of Lille

 

Research topics: NeuroPDT research unit develops PDT therapies for high-grade gliomas and is currently investigating novel balloon illumination device for glioblastoma in clinical trials. DermatoPDT unit develops PDT for different dermatological indications and is specialized in light-emitting fabrics. ImmunoPDT unit is carrying out several projects investigating the regulation of immune response in oncological PDT. The research center also actively develops mathematical models for improved light dosimetry and treatment planning.


Actinic keratosis

Actinic keratosis (AK) is common preinvasive cancerous lesion found in skin areas frequently exposed to the sun (face, scalp, ears, neck, forearms). It may progress to invasive squamous cell carcinoma (SCC) that has significant morbidity and lethal outcome. PDT is commonly used treatment for AK, however typical PDT light sources do not deliver a uniform light distribution on the skin, which can expose patients to under- or overtreatment.

Protocol

A new flexible light device was developed that can deliver uniform light to the skin surfaces. It was evaluated in a clinical trial (ClinicalTrials.gov identifier NCT03076892) where 46 men with a total of 560 actinic keratosis lesions on forehead and scalp were treated using 30-min incubation with MAL cream followed by illumination with either conventional LED panel or novel light device (Phosistos) delivering 1.3 mW/cm2 for 2.5 hours (12 J/cm2) at 635 nm.

Novel device consists of light-emitting fabrics made of bent optical fibers that line on the inside of a cap and is connected to Modulight laser device ML7710 delivering very low, uniform irradiance without causing pain. Ergonomic helmet keeps the cap in place during the treatment.

 

Images from the original publication published with permission from the contact author of the publication.

Results

Phosistos-PDT Conventional PDT
Number of AK lesions 280 280
Complete lesion response rate At 3 months At 6 months At 3 months At 6 months
80.7 % 94.9 % 79.3 % 94.2 %
Pain experienced during PDT 0.3 ± 0.6 7.4 ± 2.3

 


 


Paget disease

Extramammary Paget disease of the vulva (EMPV) is a rare malignant skin disorder seen in postmenopausal Caucasian females. EMPV manifests as red, eczematous, chronic and sometimes painful regions that may be associated with underlying adenocarcinoma. PDT has never clearly been demonstrated treatment for EMPV and is also very painful. Hence, a novel light-emitting fabrics device for painless PDT was designed and is currently being evaluated in PAGETEX trial for treatment of EMPV.

PAGETEX trial overview

  • ClinicalTrials.gov identifier NCT03713203
  • Nonrandomized, interventional, exploratory trial
  • Single center (Lille University Hospital)
  • Trial duration 2019-2022
  • 24 women with noninvasive primary or recurrent EMPV included
  • 2 PDT sessions with a 15-day interval (+optionally later 2 additional PDT sessions)
  • Metvixia photosensitizer, 635 nm illumination with novel PAGETEX medical laser, low irradiance for a total fluence of 12 J/cm2 during 2.5 hours
  • Evaluation visits at 3 and  6 months to evaluate disease control rate and adverse events
  • The final results of the study expected to be available in Jan-2023
  • In case of positive results, randomized trial comparing PDT with imiquimod will be performed

 

Light-emitting fabrics device consists of Modulight’s ML7710 clinical laser at 635 nm connected to three light-emitting fabrics that are designed to uniformly diffuse red laser light to the vulvar area.

 

Image from the original publication reproduced under the terms of the CC BY 4.0 International License.

 

 

Conclusions:
Active clinical investigations into light-emitting fabrics for dermatological diseases are ongoing at University of Lille, INSERM. PDT using this technology was compared to conventional PDT in a clinical trial for actinic keratosis and resulted in similar efficiency while producing significantly less pain (almost pain-free) and adverse events. Unlike daylight PDT, a commonly used pain-free alternative, this therapy can be given irrespective of weather conditions or geographic location. Another indication for light-emitting fabrics is Paget disease of the vulva, for which safety and efficiency is currently being studied in a single-center PAGETEX trial.

 

Related Modulight products and Services

 

Related Publications

Light emitting fabrics for PDT: technology and results of clinical studies
Serge R. Mordon, Elise Thecua, Fabienne Lecomte, Anne-Sophie Vignion-Dewalle, Pascal Deleporte, Cyril Maire, Henry Abi-Rached, Claire Vicentini, Theresa Hommel, R. Markus Szeimies, Laurent Mortier
SPIE, 2019

 

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
Fabienne Lecomte, Elise Thecua, Laurine Ziane, Pascal Deleporte, Alain Duhamel, Cyril Maire, Delphine Staumont-Salle, Serge Mordon, Laurent Mortier
JMIR Res Protoc, 2019, 8 (12)

 

 

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