Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03713203

PAGETEX® Photodynamic Therapy Device for 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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Paget Disease of the Vulva Adenocarcinoma Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Glandular and Epithelial Paget Disease, Extramammary

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Claude Huriez, CHU

Lille, France

Location status: Recruiting

Location contact

Laurent Mortier, MD,PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pagetex PDT

Device

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

Primary outcomes

  1. disease control rate in 30% of patients included

    Time frame: At 3 months

    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

  1. disease control rate in 30% of patients included

    Time frame: at 6 months

    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

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

    Time frame: 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)

    Visual Analogic Scale Evaluation of pain (0 = no pain to 10= unbearable)

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

    Time frame: at 3 months, at 6 months

    erythema 4 points scale (0 = no erythema, 3=severe erythema) and Chroma meter CR400 (Konica Minolta) measures

  4. Presence/absence of Paget cells in vulvar biopsy.

    Time frame: at 3 months, at 6 months

  5. Change in score Dermatology Life Quality Index (DLQI)

    Time frame: at 3 months, at 6 months

    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

  6. Change in SF 36

    Time frame: at 3 months, at 6 months

  7. Change in Hospital Anxiety and Depression Scale. (HADS)

    Time frame: at 3 months, at 6 months

    Each item on the questionnaire is scored from 0-3

  8. Change in The Female Sexual Function Index (FSFI)

    Time frame: at 3 months, at 6 months

    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

  9. Presence or absence of fluorescence on the Dermoscope Fotofinder® photographs

    Time frame: at 6 months

  10. number of Adverse Events

    Time frame: during the study period, an average 6 months

    Incidence and severity of adverse device effects during the study period

Study contacts

Contact information is provided by the study sponsor or research team.

Laurent Mortier, MD,PhD

CONTACT

[email protected]

(0)3 20 44 48 68 ext. +33

Serge Mordon, MD,PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Galderma R&D
  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Official study title

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)

Acronym: PAGETEX

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Oct 19, 2018
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.