PAGETEX® Photodynamic Therapy Device for the Treatment of Extra Mammary Paget's Disease of the Vulva (EMPV).

Launched by UNIVERSITY HOSPITAL, LILLE · Oct 18, 2018

Keywords

ClinConnect Summary

This clinical trial is studying the use of a special light-based treatment called photodynamic therapy (PDT) for women with a rare skin condition known as vulvar Paget's disease. This disease often shows up as red, itchy patches on the skin and can be difficult to diagnose, sometimes taking years before it's recognized. The usual treatment involves surgery, but there is a chance that the condition can come back afterward. The trial aims to see if the new PAGETEX device can effectively and safely treat this disease, especially in women whose condition has returned after surgery.

To participate in this study, women aged 65 to 74 who have been diagnosed with non-invasive vulvar Paget's disease may be eligible, as long as they can give their consent and follow the study guidelines. Participants should be able to undergo a biopsy that confirms their condition and must not have had certain treatments or conditions that could interfere with the study. Those who join the study can expect to receive the new treatment and will be monitored closely for any side effects or results. It’s important to know that this trial is still recruiting participants, and it offers a potential new option for managing a challenging condition.

Gender

FEMALE

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