NCT03713203 PAGETEX® Photodynamic Therapy Device for the Treatment of Extra Mammary Paget's Disease of the Vulva (EMPV).
| NCT ID | NCT03713203 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Lille |
| Condition | Paget Disease of the Vulva |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2019-08-27 |
| Primary Completion | 2026-08-27 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 24 participants in total. It began in 2019-08-27 with a primary completion date of 2026-08-27.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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 Exclusion Criteria: * 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
Contact & Investigator
Laurent Mortier, MD,PhD
PRINCIPAL INVESTIGATOR
University Hospital, Lille
Frequently Asked Questions
Who can join the NCT03713203 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Paget Disease of the Vulva. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03713203 currently recruiting?
Yes, NCT03713203 is actively recruiting participants. Contact the research team at laurent.mortier@chru-lille.fr for enrollment information.
Where is the NCT03713203 trial being conducted?
This trial is being conducted at Lille, France.
Who is sponsoring the NCT03713203 clinical trial?
NCT03713203 is sponsored by University Hospital, Lille. The principal investigator is Laurent Mortier, MD,PhD at University Hospital, Lille. The trial plans to enroll 24 participants.