PAGETEX® Photodynamic Therapy Device for the Treatment of Extra Mammary Paget's Disease of the Vu… (NCT03713203) | Clinical Trial Compass
RecruitingNot Applicable
PAGETEX® Photodynamic Therapy Device for the Treatment of Extra Mammary Paget's Disease of the Vulva (EMPV).
France24 participantsStarted 2019-08-27
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.