PAGETEX® Photodynamic Therapy Device for the Treatment of Extra Mammary Paget's Disease of the Vulva (EMPV).
About this study
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.
- Condition
- Paget Disease of the Vulva, Paget Disease, Extramammary
- Tested
- pagetex PDT
- Sponsor
- University Hospital, Lille
Who can join
- Age
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
Inclusion 8
- Minimum age: 18 years
- Eligible sex: Female
- Study condition: Paget Disease of the Vulva, Paget Disease, Extramammary
- 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
Exclusion 16
- Invasive vulvar Paget's Disease
- Underlying adenocarcinoma
- Subject to photosensitive disorders / reactions
- Treatment with Imiquimod / Aldara 5% cream in the last 3 months
- Photodynamic therapy used to treat MPV lesions in the last 3 months
- Use of photosensitive agents in the last 3 months
- Treatment with an experimental drug in the 30 days prior to the start of the study,
- Allergic or hypersensitivity to methyl aminolevulinate or any of the other ingredients of this medication (propyl p-hydroxybenzoate, cetostearyl alcohol, methyl p-hydroxybenzoate)
- Allergic or hypersensitivity to peanut or soya due to the presence of peanut oil in Metvixia®
- Patient with Porphyria
- Patient already treated with topical corticosteroids on the injured area in the last 3 months
- Patients with immunity disorders (HIV, transplantation)
- Clinical follow-up impossible for psychological, family, social or geographical reasons,
- Legal incapacity
- Pregnant or lactating woman
- Refuse to participate in or sign the consent of the study
Where
1 site, 1 recruiting
Hôpital Claude Huriez, CHU
Lille, France
Contact
-
Laurent Mortier, MD,PhD
(0)3 20 44 48 68 laurent.mortier@chru-lille.fr
-
Serge Mordon, MD,PhD
Potential match only. Final eligibility is determined by the study team.