This is a phase 2, randomized, double blind, multicenter study evaluating the efficacy and safety of the combination of methotrexate plus UVB TL01 in vitiligo.
Treatment Strategy: Multicentric, parallel double blind randomized phase 2 prospective study comparing MTX taken orally once a week + narrowband UVB TL01 versus placebo + narrowband UVB TL01 Follow-up of the study: patients included in this study will start MTX 2 months before starting narrowband UVB TL01. Phototherapy will be performed twice a week during 6 months. Follow-up visit will be done at month 2, 4 and month 8. Phone calls to the patient will be done at month 6
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
32
oral capsules taken once a week
Administered identically to the experimental group
Service de Dermatologie - Hôpital Saint-André
Bordeaux, Bordeaux, France
Centre Hospitalier de Pau
Pau, France
Centre Hospitalier de Périgueux
Périgueux, France
Service de Dermatologie - CHU de Toulouse - Hopital Purpan
Toulouse, France
Score with VASI formule
The VASI Score is used to assess the severity and extent of Vitilgo. VASI is calculated using a formula that includes contributions from all body regions (possible range, 0-100). The body is divided into 6 separate and mutually exclusive sites (head/neck, hands, upper extremities \[excluding hands\], trunk, lower extremities \[excluding feet\], and feet), with percentage of vitiligo involvement estimated in hand units by the same investigator throughout the study.
Time frame: month 8
Score with VASI formule
Change in percentage of repigmented Surface area 4 months after-inclusion, by using the VASI score at M4. The VASI Score is used to assess the severity and extent of Vitilgo. VASI is calculated using a formula that includes contributions from all body regions (possible range, 0-100). The body is divided into 6 separate and mutually exclusive sites (head/neck, hands, upper extremities \[excluding hands\], trunk, lower extremities \[excluding feet\], and feet), with percentage of vitiligo involvement estimated in hand units by the same investigator throughout the study.
Time frame: month 4
Number of Adverse Events (AE) and serious adverse events (SAE), as well as the proportion of discontinuation due to AEs and/or SAEs
AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related, that occurs after a subject provides informed consent. Abnormal laboratory values or test results occurring after informed consent constitute AEs only if they induce clinical signs or symptoms, are considered clinically meaningful, require therapy, or require changes in the study drug.
Time frame: Month 8
Evaluation of score Vitiligo European Task Force (VETF)
Variation of the score Vitiligo European Task Force (VETF) The VETF score is used to assess the severity and extent of vitiligo. The VETF assesses 3 dimensions of the disease in 5 areas (Head/neck, hands and feet, trunk, arms, legs) namely 1/ extent: percentage of vitiligo involvement estimated using the rule of nines, 2/ depigmentation severity grading (stage 0: normal pigmentation Stage 1: incomplete pigmentation , stage 2 complete depigmentation, stage 3: partial hair whitening \<30% stage 4: complete hair whitening) and 3/ spreading (score O: similar limits, Score 1: progressive vitiligo; score -1: regressive vitiligo).
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Time frame: Month 4
Evaluation of score Vitiligo European Task Force (VETF)
Variation of the score Vitiligo European Task Force (VETF) The VETF score is used to assess the severity and extent of vitiligo. The VETF assesses 3 dimensions of the disease in 5 areas (Head/neck, hands and feet, trunk, arms, legs) namely 1/ extent: percentage of vitiligo involvement estimated using the rule of nines, 2/ depigmentation severity grading (stage 0: normal pigmentation Stage 1: incomplete pigmentation , stage 2 complete depigmentation, stage 3: partial hair whitening \<30% stage 4: complete hair whitening) and 3/ spreading (score O: similar limits, Score 1: progressive vitiligo; score -1: regressive vitiligo).
Time frame: Month 8
Evaluation of score of the Vitiligo Extent Score (VES)
Variation in percentage of the Vitiligo Extent Score (VES). The VES score is used to assess the severity and extent of vitiligo. Using the VES calculator www.vitiligo-calculator.com, investigator choose the pictures that best represent the patient's skin lesions and then the percentage of depigmented area is calculated.
Time frame: Month 4
Evaluation of score of the Vitiligo Extent Score (VES)
Variation in percentage of the Vitiligo Extent Score (VES). The VES score is used to assess the severity and extent of vitiligo. Using the VES calculator www.vitiligo-calculator.com, investigator choose the pictures that best represent the patient's skin lesions and then the percentage of depigmented area is calculated.
Time frame: Month 8
Evaluation of score of the Dermatology Life Quality Index (DLQI)
Variation of the score of the Dermatology Life Quality Index (DLQI). DLQI is a 10-item instrument, each item scored from 0 to 3 where higher scores correspond to worse symptom impact, full range from 0 to 30.
Time frame: Month 4
Evaluation of score of the Dermatology Life Quality Index (DLQI)
Variation of the score of the Dermatology Life Quality Index (DLQI). DLQI is a 10-item instrument, each item scored from 0 to 3 where higher scores correspond to worse symptom impact, full range from 0 to 3.
Time frame: Month 8
Evaluation of the score of the Skindex 29
Variation of the score of the Skindex 29. SkinDex29 is a 30-item instrument, each item scored from 1 to 5 where higher scores correspond to worse symptom impact, full range from 0 to 150.
Time frame: Month 4
Evaluation of the score of the Skindex 29
Variation of the score of the Skindex 29. SkinDex29 is a 30-item instrument, each item scored from 1 to 5 where higher scores correspond to worse symptom impact, full range from 0 to 150.
Time frame: Month 8
Evaluation of the score of the Vitiligo Impact Scale (VIP)
Variation of the score of the Vitiligo Impact Scale (VIP). Vitiligo Impact Scale is a 2-item instrument, each item scored from 0 to 5 where higher scores correspond to worse symptom impact, full range from 0 to 145
Time frame: Month 4
Evaluation of the score of the Vitiligo Impact Scale (VIP)
Variation of the score of the Vitiligo Impact Scale (VIP). Vitiligo Impact Scale is a 2-item instrument, each item scored from 0 to 5 where higher scores correspond to worse symptom impact, full range from 0 to 145
Time frame: Month 8
Evaluation of blood inflammatory markers using immunofluorescence on skin biopsies and ELISA multiplex.
Epression of MxA CD3, CD4, CD8, CXCR3, CCR6, CXCL9, 10, 11, CCL20 et HSP70
Time frame: Day 1
Evaluation of skin inflammatory markers using immunofluorescence on skin biopsies and ELISA multiplex.
Expression of IFN-α, TNF-α, IFN-γ, IL-17, IL-22, CXCL4, CXCL9, CXCL10, CXCL11, CXCL12, CXCL16, CCL20, HSP70 soluble
Time frame: Day 1