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)
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.
• Non-invasive, primary or recurrent vulvar Paget's disease after surgical resection
• Ability to give informed consent.
• Ability to adhere to the study protocol
• Patients must have biopsy (\< 1year) proven recurrent extra mammary Paget's disease
• Effective contraception for Women of childbearing potential