Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A01873-52 | Other Identifier | ID-RCB number, ANSM | |
| 2018-002604-13 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Galderma R&D | INDUSTRY |
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pagetex PDT | Experimental | PAGETEX medical device for photodynamic therapy (PDT). Composed of the association: "Laser source + optical fiber + diffuser support incorporating luminous textiles + drug photosensitizer (Metvixia®)" |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pagetex PDT | Device | 2 to 4 sessions of PDT treatment during 2.5 hours after application of Metvixia and incubation under occlusive coat. |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Patients diagnosed with Paget's Disease Extra-Mammary Vulvae confirmed by biopsy of less than one year.
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laurent Mortier, MD,PhD | Contact | (0)3 20 44 48 68 | +33 | laurent.mortier@chru-lille.fr |
| Serge Mordon, MD,PhD | Contact | serge.mordon@inserm.fr |
| Name | Affiliation | Role |
|---|---|---|
| Laurent Mortier, MD,PhD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Claude Huriez, CHU | Recruiting | Lille | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31793891 | Result | Lecomte F, Thecua E, Ziane L, Deleporte P, Duhamel A, Maire C, Staumont-Salle D, Mordon S, Mortier L. Photodynamic Therapy Using a New Painless Light-Emitting Fabrics Device in the Treatment of Extramammary Paget Disease of the Vulva (the PAGETEX Study): Protocol for an Interventional Efficacy and Safety Trial. JMIR Res Protoc. 2019 Dec 3;8(12):e15026. doi: 10.2196/15026. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010145 | Paget Disease, Extramammary |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| D009369 | Neoplasms |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |