Progressive vitiligo MedDRA version: 21.1 Level: PT Classification code 10047642 Term: Vitiligo System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Trade Name: IMETH 10mg
Pharmaceutical Form: Capsule, hard
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Trade Name: IMETH 2.5mg
Pharmaceutical For
Sponsors
CHU de Bordeaux
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subject male or female age over 18 years old - Diagnosis of non-segmental (symmetrical) vitiligo with body surface area =10% - Active non-segmental vitiligo defined by Non-segmental vitiligo with new patches or extension of old lesions during the last 6 months AND Presence of hypochromic aspect under Wood’s lamp examination and/or perifollicular hypopigmentation under Wood’s lamp examination. - Signed informed consent document - Male patients agreeing to use a reliable method of birth control during the study i. e. preservative and for at least 6 months following the last dose of investigational product, the patient's partner treated by methotrexate must be notified of the teratogenic risk of methotrexate and should be under effective contraception throughout the study and for at least 6 months following the last dose of investigational product. - Women of childbearing potential who are negatively tested for pregnancy and agree to use a reliable method of birth control (every month) or remain abstinent during the study and for at least 6 months following the last dose of investigational product. Methods of contraception considered acceptable include oral contraceptives, contraceptive patch, intrauterine device, vaginal ring - Patient registered to the French Social Security Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: - Segmental or mixed vitiligo - Patients who have known active liver disease (with the exception of a simple liver steatosis, transaminases and/or alkaline phosphatases > 2 ULM ) or history of liver disease in the past 2 years, whatever the related diagnosis but which could interfere with MTX safety and according to the summary of the SmPC. - Intake of restricted medications (cf section VIII.5.) or other drugs considered likely to interfere with the safe conduct of the study, as assessed by the investigator and according to the Summary of the Product Characteristics (SmPC), including any drug intakes that could interfere with methotrexate metabolism or that could enhance liver and /or hematologic toxicity and according to the SmPC - Patient with evidence or positive test for HIV, Hepatitis C virus, Hepatitis B virus (patients who are negative for hepatitis B surface antigen but positive for anti-hepatitis B anti body (HBsAb+ and HBcAb+) and negative for serum HBV DNA may participate in the study - High alcohol intake defined as more than 60 g of daily intake (approx daily intake of 0.5 l of wine or equivalent), - Patients who have a known allergy or hypersensitivity to MTX - Patients who have a known serious adverse event to MTX prior to the trial leading to MTX discontinuation in the past - Presence of significant hematologic or renal disorder or abnormal laboratory values at screening that, in the opinion of the investigator is associated with an unacceptable risk to the patient to participate in the study - Clinical laboratory test results at screening that are outside a normal reference rating for the population and are considered clinically significant, or/and have any of the following specific abnormalities: -Total white blood cell count 3 times the upper limit of normal (ULM) -Hemoglobin <8.5g/dL (85.0 g/L) -Creatinine clearance <40ml/min (Cockcroft formula) - For women: pregnant or breast feeding - Patients who have an active or serious infection or history of infections (bacterial, viral, fungal or mycobacteria), requiring hospitalization or intra venous anti-infectives infusion within 4 weeks prior to the baseline, - Patients who have primary or secondary active immunodeficiency - Patients who had live vaccine administration within 4 weeks prior to baseline - Patients who had already been treated by at least 250 sessions of phototherapy - Patients who have any current or active cancer (with the exception of patient with successfully treated with in situ cervix carcinoma) - Patients who had history of malignancy within 5 years prior to the trial that could contraindicate the use of an immunosuppressant - Patients who will not be available for protocol which require study visits or procedures - Patients who is not affiliated to the French Social Security system - Patients unable to give informed consent and/or comply with all required study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Variation in percentage of repigmented surface area 8 months after inclusion, by using the VASI score. ;Secondary Objective: •Variation in percentage of repigmented surface area 4 months after inclusion, by using the VASI score •Following criteria will be evaluated 4 and 8 months after inclusion - Analysis of clinical and biological tolerance of MTX and phototherapy - Variation of the score Vitiligo European Task Force (VETF) at month 8 : - Variation in percentage of the Vitiligo Extent Score (VES) at month 8. - Variation in percentage of the F-VASI at month 8 - Variation of the score of the Dermatology Life Quality Index (DLQI) measured - Variation of the score of the Skindex 29. - Variation of the score of the Vitiligo Impact Scale (VIP). - Variation of blood and skin inflammatory markers. ;Primary end point(s): The main assessment criterion is the VASI score reduction in the experimental group receiving MTX + UVB TL01 assessed 8 months after the start of treatment. With the integration in the study of a group of randomized calibration receiving Placebo + UVB TL01, the assessment of the main assessment criterion will be without knowledge of the treatment received. In the VASI score body is divided in 5 regions (hands, limbs, trunk, limbs and feet). The surface reached on each region is evaluated by the unit "Palm of hand". The importance of residual pigmentation within a target lesion is expressed as a percentage: 0%, 10%, 25%, 50%, 75%, 100%. The VASI score is then evaluated by a mathematical formula including the surface reached for each region with the percentage of residual pigmentation.;Timepoint(s) of evaluation of this end point: Month 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary evaluation criteria are also evaluated without knowledge of the treatment received. The reduction of the VASI score will also be evaluated to M4. The following criteria will be evaluated to M4 and M8:-measures clinical and biological safety of MTX and phototherapy. -changes in the score VETF: VETF score: three areas are assessed: 1 / the skin surface: the body is divided into 5 regions (face and neck, trunk, upper limbs, lower limbs, feet and hands) and the surface is estimated by the rule 9, 2 / severity depigmentation is evaluated by criteria ranging from 0 to 4 (0: normal pigmentation, 1: incomplete pigmentation, 2: complete depigmentation, 3: presence of white hairs < 30%, 4: complete depigmentation of the hair), 3 / the progression assessed by 3 criteria (0): similar limitations, + 1 progression, regression-1). -variation of the students score: this score is built from images representing different parts of the body (face and neck, tron...;Timepoint(s) of evaluation of this end point: Month 8 | — |
Countries
France
Contacts
Public ContactProject manager
CHU de Bordeaux
Outcome results
None listed