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

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Paget Disease, Extramammary; Paget Disease of the Vulva
• Intervention / Treatment: Device: pagetex PDT

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laurent Mortier, MD,PhD; Phone Number: +33 (0)3 20 44 48 68; Email: laurent.mortier@chru-lille.fr
• Study Contact Backup: Name: Serge Mordon, MD,PhD; Email: serge.mordon@inserm.fr

Study Locations

• France
  • Lille, France
    • Recruiting
    • Hôpital Claude Huriez, CHU
    • Principal Investigator: Laurent Mortier, MD,PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pagetex PDT; 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; 2 to 4 sessions of PDT treatment during 2.5 hours after application of Metvixia and incubation under occlusive coat.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 6 months
Subject discomfort measured during each treatment using a Visual Analogic Scale Evaluation of pain	Visual Analogic Scale Evaluation of pain (0 = no pain to 10= unbearable)	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	erythema 4 points scale (0 = no erythema, 3=severe erythema) and Chroma meter CR400 (Konica Minolta) 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)	DLQI is a ten-question questionnaire used to measure the impact of skin disease on the quality of life of an affected person The scoring of each question is as follows:Very much/A lot/A little/Not at all/Not relevan	at 3 months, at 6 months
Change in SF 36		at 3 months, at 6 months
Change in Hospital Anxiety and Depression Scale. (HADS)	Each item on the questionnaire is scored from 0-3	at 3 months, at 6 months
Change in The Female Sexual Function Index (FSFI)	The FSFI is a brief questionnaire measure of sexual functioning in women. 19 questions scoring as follow : 0 = Did not attempt intercourse ;1 = Almost always or always 2 = Most times (more than half the time);3 = Sometimes (about half the time);4 = A few times (less than half the time); 5 = Almost never or never	at 3 months, at 6 months
Presence or absence of fluorescence on the Dermoscope Fotofinder® photographs		at 6 months
number of Adverse Events	Incidence and severity of adverse device effects during the study period	during the study period, an average 6 months

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France; Galderma R&D
• Investigators: Principal Investigator: Laurent MORTIER, MD,PhD, University Hospital, Lille

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2019
• Primary Completion (Estimated): August 27, 2026
• Study Completion (Estimated): August 27, 2026

Study Registration Dates

• First Submitted: October 15, 2018
• First Submitted That Met QC Criteria: October 18, 2018
• First Posted (Actual): October 19, 2018

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Photodynamic Therapy (PDT); Medical Device; Paget Disease; Metvixia®
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Carcinoma; Neoplasms, Ductal, Lobular, and Medullary; Paget Disease, Extramammary
• Other Study ID Numbers: 2017_71; 2018-A01873-52 (Other Identifier: ID-RCB number, ANSM); 2018-002604-13 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No