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

ConditionsPaget Disease of the VulvaPaget Disease, Extramammary
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity Hospital, Lille

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Invasive vulvar Paget's Disease

Underlying adenocarcinoma

Subject to photosensitive disorders / reactions

Treatment with Imiquimod / Aldara 5% cream in the last 3 months

Trial design

Design model

Single group

Treatments tested in this trial

  • pagetex PDT

    Device

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

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: Pagetex PDTExperimental treatment 1 intervention

Trial outcomes

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

Time frame
At 3 months

Secondary 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

Time frame
at 6 months
2

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)

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)
3

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

Time frame
at 3 months, at 6 months
4

Presence/absence of Paget cells in vulvar biopsy.

Time frame
at 3 months, at 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Lille

Lead sponsor

Galderma R&D

Collaborator

Institut National de la Santé Et de la Recherche Médicale, France

Collaborator

Source ClinicalTrials.gov
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