Informations générales (source: ClinicalTrials.gov)
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) (PAGETEX)
Interventional
N/A
University Hospital, Lille (Voir sur ClinicalTrials)
août 2019
août 2026
08 avril 2025
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Hôpital Claude Huriez, CHU - Lille - France | Contact (sur clinicalTrials) | ||||
Critères
Femme
Inclusion Criteria:
- 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
- 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
- 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