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

University Hospital, Lille

Status: Enrolling

Conditions: Paget Disease of the Vulva; Paget Disease, Extramammary

Treatments: Device: pagetex PDT

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03713203

2017_71

2018-A01873-52 (Other Identifier)

2018-002604-13 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Pagetex PDT

Experimental group

Description:

PAGETEX medical device for photodynamic therapy (PDT). Composed of the association: "Laser source + optical fiber + diffuser support incorporating luminous textiles + drug photosensitizer (Metvixia®)"

Treatment:

Device: pagetex PDT