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)
University Hospital, Lille
24 participants
Aug 27, 2019
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria16
- 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
Interventions
2 to 4 sessions of PDT treatment during 2.5 hours after application of Metvixia and incubation under occlusive coat.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03713203