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.
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.
|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|
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.
Related Modulight products and Services
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
JMIR Res Protoc, 2019, 8 (12)
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