NCT03713203

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

An Interventional, Phase II, Non Randomized, Mono-centric Study on the Clinical Efficacy and Safety of the Medical Device PAGETEX® as a Photodynamic Therapy Device in the Treatment of Extra-Mammary Paget's Disease of the Vulva (EMPV)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: University Hospital, Lille · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Vulvar Paget's disease is a rare skin tumour which affect Caucasian post-menopausal women. The disease is revealed by erythematous, eczematous, pruritus and vulvar burns. The diagnosis is often late (from a few months to several years) because the symptoms are neglected by patients or misinterpreted by doctors. The reference treatment is based on surgical excision but unfortunately local recurrences are very frequent (17 to 38% of cases). Photodynamic therapy (PDT) is already used in some dermatological pathologies and could therefore be an alternative treatment. The objective of this study is to assess the efficacy and evaluate the safety of the new PDT device "PAGETEX" for the treatment of vulvar Paget's disease.

Conditions

• Paget Disease of the Vulva
• Paget Disease, Extramammary

Interventions

Type	Name	Description
DEVICE	pagetex PDT	2 to 4 sessions of PDT treatment during 2.5 hours after application of Metvixia and incubation under occlusive coat.

Timeline

• Start date: 2019-08-27
• Primary completion: 2026-08-27
• Completion: 2026-08-27
• First posted: 2018-10-19
• Last updated: 2025-04-06

Locations

1 site across 1 country: France