PAGETEX® Photodynamic Therapy Device for the Treatment of Extra Mammary Paget's Disease of the Vulva (EMPV).
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity Hospital, Lille
About this trial
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 criteria
Qualifiers
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
Disqualifiers
Invasive vulvar Paget's Disease
Underlying adenocarcinoma
Subject to photosensitive disorders / reactions
Treatment with Imiquimod / Aldara 5% cream in the last 3 months
Trial design
Treatments tested in this trial
- pagetex PDT
Treatment groups
24 Participants
are divided into 1 treatment groupSponsors and collaborators
University Hospital, Lille
Lead sponsor
Galderma R&D
Collaborator
Institut National de la Santé Et de la Recherche Médicale, France
Collaborator
Source ClinicalTrials.gov