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

Last updated: April 2, 2025
Sponsor: University Hospital, Lille
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

pagetex PDT

Clinical Study ID

NCT03713203
2017_71
2018-002604-13
2018-A01873-52
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

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

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 otheringredients 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 inMetvixia®

  • 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 geographicalreasons,

  • Legal incapacity

  • Pregnant or lactating woman

  • Refuse to participate in or sign the consent of the study

Study Design

Total Participants: 24
Treatment Group(s): 1
Primary Treatment: pagetex PDT
Phase:
Study Start date:
August 27, 2019
Estimated Completion Date:
August 27, 2026

Connect with a study center

  • Hôpital Claude Huriez, CHU

    Lille,
    France

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.