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New treatment option for Paget Disease of the Vulva
Official title PAGETEX® Photodynamic Therapy Device for the Treatment of Extra Mammary Paget's Disease of the Vulva (EMPV).
ClinicalTrials.gov ID: NCT03713203
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Lille, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lille, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.