METHYL AMINOLEVULINATE for Extra-mammary Paget disease of the vulva

Inclusion criteria

• {"criterion_text":"- Non-invasive, primary or recurrent vulvar Paget's disease after surgical resection\n- Biopsy confirming the diagnosis less than one year old\n- Woman aged ≥18 years\n- Patient capable of understanding and voluntarily forming informed consent\n- Patient capable of adhering to the study visit schedule and other protocol requirements\n- Women of childbearing age must benefit from effective contraception\n- Status of social insured or entitled to social security"}

Exclusion criteria

• {"criterion_text":"- Invasive Paget's disease\n- Patient suffering from Porphyria\n- Patient already treated with topical corticosteroids on the injured area in the last 3 months\n- Patients with immune disorders (HIV, transplantation)\n- Clinical follow-up impossible for psychological, family, social or geographical reasons\n- Legal incapacity (persons deprived of liberty or under guardianship or curatorship)\n- Pregnant or breastfeeding woman\n- Refusal to participate or sign study consent\n- Underlying adenocarcinoma\n- Prone to reaction/photosensitive disorders\n- Treatment with Imiquimod/Aldara 5% cream in the last 3 months\n- Photodynamic Therapy used to treat MPV lesions within the last 3 months\n- Uses of photosensitive agents in the last 3 months\n- Treatment with an investigational drug within 30 days before the start of the study\n- Allergic or hypersensitivity to methyl aminolevulinate or any of the other ingredients contained in this medicine (propyl p-hydroxybenzoate, cetostearyl alcohol, methyl p-hydroxybenzoate)\n- Allergic or hypersensitive to peanut or soy due to the presence of peanut oil in Metvixia®"}

Primary endpoints

• {"endpoint_text":"- disease control rate defined by the proportion of patients having a clinical response (stability, partial response or complete response to treatment compared to patients who are in progressive disease (increase in size of the lesion, progression to invasive disease and/or adenocarcinoma). The clinical response will be obtained by the investigating doctor during the 3-month visit using the photograph of the lesion at inclusion as a reference.","definition_or_measurement_approach":"Clinical response (stability, partial response or complete response vs progressive disease) assessed by the investigating doctor at the 3-month visit using the inclusion photograph of the lesion as reference."}

Secondary endpoints

• {"endpoint_text":"- The disease control rate at 6 months, assessed by the investigating doctor","definition_or_measurement_approach":"Assessed by the investigating doctor at 6 months using same criteria as primary endpoint."}
• {"endpoint_text":"- The disease control rate at 3 and 6 months evaluated by an independent committee of doctors (same definition and grading as by the investigating doctor) based on standardized photographs taken during the inclusion visits, at 3 months and at 6 months","definition_or_measurement_approach":"Independent committee assessment based on standardized photographs from inclusion, 3 months and 6 months using same response definitions."}
• {"endpoint_text":"- The level of quality of life, quality of sexual life, anxiety and depression of the patient assessed from the analysis of the scores of questionnaires validated for dermatology: DLQI, HADS scale, FSFI, SF36 completed at the inclusion visit, at 3 months and at 6 months","definition_or_measurement_approach":"Patient-completed validated questionnaires (DLQI, HADS, FSFI, SF36) at inclusion, 3 months and 6 months; scores analysed to assess QoL, sexual life, anxiety and depression."}
• {"endpoint_text":"- The level of pain felt by the patient during each PDT session assessed using a visual analog scale (VAS) graded from 0 (no pain) to 10 (unbearable pain). The level of pain will be classified into 4 levels: 0 = no pain/reaction 1 to 3 = pain/weak reaction 4 to 6 = moderate pain/reaction 7 to 10 = severe pain/reaction","definition_or_measurement_approach":"Pain measured by VAS 0–10 during each PDT session; classified into four categories: 0, 1–3, 4–6, 7–10."}
• {"endpoint_text":"- The presence of Paget cells in the thickness of the epidermis after staining of biopsies using the hematoxylin and eosin staining technique (H&E staining). A vulvar biopsy will be performed for each suspicious lesion, whether or not it is symptomatic at the 3-month and 6-month visit","definition_or_measurement_approach":"Histological assessment (H&E) of vulvar biopsies at 3 and 6 months for presence of Paget cells."}
• {"endpoint_text":"- The severity of the erythema at the inclusion visit, at 3 months and at 6 months noted by: The investigating doctor on the basis of a 4-point scale: 0 = no erythema, 1 = mild erythema or pruritus, 2 = moderate erythema (macules, papules, dry desquamation), 3 = severe erythema (vesicles, ulceration, desquamation oozing, necrotic) A quantitative measurement, carried out by colorimetry of an area of damaged skin/or mucosa, defined at inclusion, which will be carried out on 10 to 20 distinct","definition_or_measurement_approach":"Investigator-rated 4-point erythema scale at inclusion, 3 and 6 months; plus quantitative colorimetry measurement on defined skin/mucosa area (10–20 points)."}
• {"endpoint_text":"- The presence of PpIX in cancer cells after each PDT session effectively using the Fotofinder® dermoscope. The presence or absence of fluorescence on the images will confirm the presence or absence of residual PpIX and therefore the complete or partial destruction of Paget's cells after the PDT session","definition_or_measurement_approach":"Fotofinder® dermoscope imaging for PpIX fluorescence after each PDT session; presence/absence of fluorescence documented."}
• {"endpoint_text":"- The patient's overall level of satisfaction measured at 6 months of PDT treatment (final visit) by the overall score of a self-questionnaire collecting the patient's impressions in terms of practicality of use, comfort, size, duration of treatment and improvement to be made to the device.","definition_or_measurement_approach":"Patient self-questionnaire at 6 months producing overall satisfaction score covering practicality, comfort, size, duration and suggested improvements."}
• {"endpoint_text":"- Collection of all adverse events (AEs and SAEs) from the start of PDT treatment until the last study visit (according to the drift criteria of the National Cancer Institute (NCI-CTCAE version 4.0) after each PDT session and at each follow-up visit (3 months and 6 months => see paragraph 11.3 for details).","definition_or_measurement_approach":"All AEs/SAEs recorded from treatment start to last visit; graded per NCI-CTCAE v4.0 after each PDT session and at follow-up visits."}

France

Earliest CTIS Part Ii Submission Date

14-08-2024

Latest Decision Or Authorization Date

06-08-2025

Processing Time Days

357

Number Of Sites

1

Number Of Participants

24

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Lille

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"France","full_name":"Lille University Hospital Center (France","duties_or_roles":"Monetary support","organisation_type":""}
• {"country":"France","full_name":"LILLE Inserm U1189 ONCO THAI Bâtiment ONCOLILLE, Boulevard du Pr. Jules Leclerc, 59000 Lille Cedex","duties_or_roles":"Monetary support","organisation_type":""}
• {"country":"SWITZERLAND","full_name":"GALDERMA S.A. Global R&D Rue d'Entre-deux-Villes 10-12 1014 La Tour-de Peilz, SWITZERLAND","duties_or_roles":"Monetary support","organisation_type":""}