Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
ID03713203

An Interventional Study on the Safety and Effectiveness of PAGETEX Photodynamic Therapy Device for Extra-Mammary Paget's Disease of the Vulva

Led by University Hospital, Lille · Updated on 2026-05-05

24

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University Hospital, Lille

Lead Sponsor

G

Galderma R&D

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying the use of the PAGETEX photodynamic therapy (PDT) device to treat vulvar Paget's disease, a rare skin tumor mainly affecting Caucasian post-menopausal women. This condition often appears late due to overlooked symptoms like redness, itching, and burning. While surgery is the usual treatment, local recurrences happen frequently, so this study aims to evaluate the safety and effectiveness of PAGETEX as an alternative treatment option. The PAGETEX device combines a laser source, optical fiber, luminous textiles, and a drug photosensitizer called Metvixia. Participants will receive 2 to 4 PDT treatment sessions lasting about 2.5 hours each, involving application and incubation of Metvixia under an occlusive cover. Treatments are spaced 15 days apart, with additional sessions possible if lesions persist. During the study, participants will be monitored for disease control at 3 and 6 months, discomfort levels during treatment, changes in skin redness, presence of disease cells in biopsies, and quality of life measures including anxiety, sexual function, and general health. Safety is assessed by tracking adverse events over approximately 6 months. The study is led by University Hospital, Lille and participants will be followed closely using clinical evaluations and specialized imaging tools.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Non-invasive, primary or recurrent vulvar Paget's disease after surgical resection
  • Ability to give informed consent
  • Ability to adhere to the study protocol
  • Biopsy-proven recurrent extra mammary Paget's disease within the last year
  • Effective contraception for women of childbearing potential
Not Eligible

You will not qualify if you...

  • Invasive vulvar Paget's Disease
  • Underlying adenocarcinoma
  • Photosensitive disorders or reactions
  • Treatment with Imiquimod or Aldara 5% cream in the last 3 months
  • Photodynamic therapy for MPV lesions in the last 3 months
  • Use of photosensitive agents in the last 3 months
  • Treatment with an experimental drug within 30 days prior to study start
  • Allergic or hypersensitivity to methyl aminolevulinate or other ingredients in Metvixia
  • Allergy to peanut or soya due to peanut oil in Metvixia
  • Porphyria
  • Use of topical corticosteroids on the injured area in the last 3 months
  • Immunity disorders such as HIV or transplantation
  • Inability to follow clinical follow-up for psychological, family, social, or geographical reasons
  • Legal incapacity
  • Pregnancy or lactation
  • Refusal to participate or sign consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Over approximately 1.5 months depending on number of sessions

Participants receive 2 to 4 sessions of photodynamic therapy treatment during 2.5 hours after application of Metvixia and incubation under occlusive coat.

2 to 4 treatment sessions spaced 15 days apart

Follow-up

Duration - Up to 6 months

Participants are monitored for disease control, clinical evolution, quality of life, and adverse events after completing photodynamic therapy.

Visits at 3 months and 6 months post-treatment

Trial Site Locations

Total: 1 location

1

Hôpital Claude Huriez, CHU

Lille, France

Actively Recruiting

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Research Team

L

Laurent Mortier, MD,PhD

S

Serge Mordon, MD,PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

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.

Fabienne Lecomte, Elise Thecua, Laurine Ziane...

https://pubmed.ncbi.nlm.nih.gov/31793891