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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Paget Disease of the Vulva, Paget Disease, Extramammary

Intervention / Treatment
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* Device: pagetex PDT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Photodynamic Therapy (PDT), Medical Device, Paget Disease, Metvixia®