PAGETEX® Therapy for Vulvar Paget's Disease
PAGETEX® Photodynamic Therapy Device for the Treatment of Extra Mammary Paget's Disease of the Vulva (EMPV).
Recruiting
N/A
Interventional Study
Paget Disease of the Vulva
Paget Disease, Extramammary
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 24 (estimated)
- Sponsor
- University Hospital, Lille · Other
Who this trial is looking for
This trial is looking for women with non-invasive vulvar Paget's disease who have had surgery but still have the disease. Participants will use a new treatment device to see if it helps their condition.
Are You a Good Fit for This Trial?
You may be able to join if
- I have non-invasive vulvar Paget's disease that came back after surgery.
- I can give informed consent.
- I can follow the study rules.
- I have had a biopsy that shows my disease is recurrent.
- I use effective birth control if I can get pregnant.
You may not be able to join if
- I have invasive vulvar Paget's disease.
- I have a type of cancer called adenocarcinoma.
- I have a photosensitivity condition.
- I used Imiquimod cream in the last 3 months.
- I have had photodynamic therapy for this disease in the last 3 months.
- I have used photosensitive agents in the last 3 months.
- I took an experimental drug in the last 30 days.
- I am allergic to certain ingredients in the treatment.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
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 recurrenc…
Trial Locations
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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 …
Contacts