Clinical trial · Interventional
PAGETEX® Photodynamic Therapy Device for the Treatment of Extra Mammary Paget's Disease of the Vulva (EMPV).
An Interventional, Phase II, Non Randomized, Mono-centric Study on the Clinical Efficacy and Safety of the Medical Device PAGETEX® as a Photodynamic Therapy Device in the Treatment of Extra-Mammary Paget's Disease of the Vulva (EMPV)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Paget Disease, Extramammary | Extramammary Paget Disease | ALIAS | 0.90 |
| Paget Disease of the Vulva | Vulvar Paget Disease | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| pagetex PDT | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pagetex PDT
- description
- PAGETEX medical device for photodynamic therapy (PDT). Composed of the association: "Laser source + optical fiber + diffuser support incorporating luminous textiles + drug photosensitizer (Metvixia®)"
- interventionNames
- Device: pagetex PDT
Primary outcomes (1)
- measure
- disease control rate in 30% of patients included
- timeFrame
- At 3 months
- description
- Clinical response will be assessed by vulvar examination by the investigator and independent medical committee. Measurement is defined as complete remission, partial remission (decrease by \>50% of total lesion size), stability ( decrease by \<50% of total lesion size )or progression of the disease
Secondary outcomes (10)
- measure
- disease control rate in 30% of patients included
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTLecomte F, Thecua E, Ziane L, Deleporte P, Duhamel A, Maire C, Staumont-Salle D, Mordon S, Mortier L. Photodynamic Therapy Using a New Painless Light-Emitting Fabrics Device in the Treatment of Extramammary Paget Disease of the Vulva (the PAGETEX Study): Protocol for an Interventional Efficacy and Safety Trial. JMIR Res Protoc. 2019 Dec 3;8(12):e15026. doi: 10.2196/15026. PMID 31793891