Study of PAGETEX Photodynamic Therapy Device to Treat Vulvar Extra-Mammary Pagets Disease in Adult Women

What this Trial Is About

Researchers are studying the use of the PAGETEX photodynamic therapy PDT device to treat vulvar Pagets disease, a rare skin tumor mainly affecting Caucasian post-menopausal women. This condition often appears late due to overlooked symptoms like redness, itching, and burning. While surgery is the usual treatment, local recurrences happen frequently, so this study aims to evaluate the safety and effectiveness of PAGETEX as an alternative treatment option. The PAGETEX device combines a laser source, optical fiber, luminous textiles, and a drug photosensitizer called Metvixia. Participants will receive 2 to 4 PDT treatment sessions lasting about 2.5 hours each, involving application and incubation of Metvixia under an occlusive cover. Treatments are spaced 15 days apart, with additional sessions possible if lesions persist. During the study, participants will be monitored for disease control at 3 and 6 months, discomfort levels during treatment, changes in skin redness, presence of disease cells in biopsies, and quality of life measures including anxiety, sexual function, and general health. Safety is assessed by tracking adverse events over approximately 6 months. The study is led by University Hospital, Lille and participants will be followed closely using clinical evaluations and specialized imaging tools.

PAGETEX® Photodynamic Therapy Device for the Treatment of Extra Mammary Paget's Disease of the Vulva (EMPV).