PAGETEX® Photodynamic Therapy Device for the Treatment of Extra Mammary Paget's Disease of the Vulva (EMPV).
- Conditions
- Paget Disease of the VulvaPaget Disease, Extramammary
- Interventions
- Device: pagetex PDT
- Registration Number
- NCT03713203
- Lead Sponsor
- University Hospital, Lille
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 24
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pagetex PDT pagetex PDT PAGETEX medical device for photodynamic therapy (PDT). Composed of the association: "Laser source + optical fiber + diffuser support incorporating luminous textiles + drug photosensitizer (Metvixia®)"
- Primary Outcome Measures
Name Time Method disease control rate in 30% of patients included 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 Outcome Measures
Name Time Method Presence/absence of Paget cells in vulvar biopsy. at 3 months, at 6 months Change in SF 36 at 3 months, at 6 months number of Adverse Events during the study period, an average 6 months Incidence and severity of adverse device effects during the study period
Subject discomfort measured during each treatment using a Visual Analogic Scale Evaluation of pain 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)
Clinical Evolution measured using an erythema 4 points scale and Chroma meter CR400 measures at 3 months, at 6 months erythema 4 points scale (0 = no erythema, 3=severe erythema) and Chroma meter CR400 (Konica Minolta) measures
Change in The Female Sexual Function Index (FSFI) 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
disease control rate in 30% of patients included 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
Change in Hospital Anxiety and Depression Scale. (HADS) at 3 months, at 6 months Each item on the questionnaire is scored from 0-3
Presence or absence of fluorescence on the Dermoscope Fotofinder® photographs at 6 months Change in score Dermatology Life Quality Index (DLQI) 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
Trial Locations
- Locations (1)
Hôpital Claude Huriez, CHU
🇫🇷Lille, France