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

NCT03713203 | Recruiting

• 3 other identifiers: 2017_712018-A01873-522018-002604-13
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Paget Disease of the Vulva; Paget Disease, Extramammary

Keywords

Photodynamic Therapy (PDT); Medical Device; Paget Disease; Metvixia®

Outcome Measures

Primary Outcomes (1)

• disease control rate in 30% of patients included

  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

  At 3 months

Secondary Outcomes (10)

• disease control rate in 30% of patients included

  at 6 months

• Subject discomfort measured during each treatment using a Visual Analogic Scale Evaluation of pain

  At session 1 and session 2, spaced 15 day; and at session 3 and session 4 spaced 15 days (sessions 3 ; 4 in case of persistent lesions)

• Clinical Evolution measured using an erythema 4 points scale and Chroma meter CR400 measures

  at 3 months, at 6 months

• Presence/absence of Paget cells in vulvar biopsy.

  at 3 months, at 6 months

• Change in score Dermatology Life Quality Index (DLQI)

  at 3 months, at 6 months

Study Arms (1)

Pagetex PDT

EXPERIMENTAL

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

Device: pagetex PDT

Interventions

pagetex PDT DEVICE

2 to 4 sessions of PDT treatment during 2.5 hours after application of Metvixia and incubation under occlusive coat.

Pagetex PDT

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Patients diagnosed with Paget's Disease Extra-Mammary Vulvae confirmed by biopsy of less than one year.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 may not qualify 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
• 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

Sponsors & Collaborators

• University Hospital, Lille: lead
• Galderma R&D: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

Hôpital Claude Huriez, CHU

Lille, France

RECRUITING

Related Publications (1)

• Lecomte 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 RESULT

MeSH Terms

Conditions

Paget Disease, Extramammary

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Ductal, Lobular, and Medullary

Study Officials

• Laurent Mortier, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurent Mortier, MD,PhD

CONTACT

(0)3 20 44 48 68; laurent.mortier@chru-lille.fr

Serge Mordon, MD,PhD

CONTACT

serge.mordon@inserm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2018
• First Posted: October 19, 2018
• Study Start: August 27, 2019
• Primary Completion (Estimated): August 27, 2026
• Study Completion (Estimated): August 27, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

FR (1)