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Combination of Methotrexate and Phototherapy Versus Phototherapy in Adults With Progressive Vitiligo (METVI)

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ClinicalTrials.gov Identifier: NCT04237103
Recruitment Status : Not yet recruiting
First Posted : January 23, 2020
Last Update Posted : March 30, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Vitiligo Drug: Methotrexate Drug: Placebos Phase 2

Detailed Description:
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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Methotrexate taken orraly once a weekcombination with UVB TL01 in a population of adult patients with progressive vitiligo
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:

The study was performed double blind. MTX will be repackaged in capsules and will look the same as placebo capsules. These capsules are packaged in vials whose labeling allows the maintenance of the blind.

The flasks are numbered in a corresponding list established by biostatistician study which specifies processing to be put in each bottle according to the number.

At each visit (inclusion and monitoring), the patient will be assigned as many lots of numbers needed to reach the next visit (2 or 4).

Only Methods Center (USMR) and Pharmacy of Bordeaux University Hospital have the correspondence between the number of treatment and nature. At no time during the study, the investigator (s) and patients will not have access to this list.

Primary Purpose: Treatment
Official Title: Efficacy and Tolerance of the Combination of Methotrexate and Phototherapy Versus Phototherapy in Adults With Progressive Vitiligo: a Randomized Double-blind Prospective Study
Estimated Study Start Date : September 2, 2021
Estimated Primary Completion Date : May 30, 2022
Estimated Study Completion Date : May 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Vitiligo
MedlinePlus related topics: Vitiligo

Arm Intervention/treatment
Experimental: methotrexate
Methotrexate once a week orally for 8 months in conjunction with narrow band UVB phototherapy starting 2 months after Methotrexate therapy for 6 months.
Drug: Methotrexate
oral capsules taken once a week
Other Name: narrow-band UVB phototherapy

Placebo Comparator: placebo
Placebo once a week orally for 8 months in conjunction with narrow band UVB phototherapy starting 2 months afterplacebo therapy, for 6 months.
Drug: Placebos
Administered identically to the experimental group
Other Name: narrow-band UVB phototherapy




Primary Outcome Measures :
  1. Score with VASI formule [ Time Frame: month 8 ]
    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.


Secondary Outcome Measures :
  1. Score with VASI formule [ Time Frame: month 4 ]

    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.


  2. Number of Adverse Events (AE) and serious adverse events (SAE), as well as the proportion of discontinuation due to AEs and/or SAEs [ Time Frame: Month 8 ]
    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.

  3. Evaluation of score Vitiligo European Task Force (VETF) [ Time Frame: Month 4 ]
    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).

  4. Evaluation of score Vitiligo European Task Force (VETF) [ Time Frame: Month 8 ]
    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).

  5. Evaluation of score of the Vitiligo Extent Score (VES) [ Time Frame: Month 4 ]
    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.

  6. Evaluation of score of the Vitiligo Extent Score (VES) [ Time Frame: Month 8 ]
    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.

  7. Evaluation of score of the Dermatology Life Quality Index (DLQI) [ Time Frame: Month 4 ]
    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.

  8. Evaluation of score of the Dermatology Life Quality Index (DLQI) [ Time Frame: Month 8 ]
    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.

  9. Evaluation of the score of the Skindex 29 [ Time Frame: Month 4 ]
    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.

  10. Evaluation of the score of the Skindex 29 [ Time Frame: Month 8 ]
    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.

  11. Evaluation of the score of the Vitiligo Impact Scale (VIP) [ Time Frame: Month 4 ]
    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

  12. Evaluation of the score of the Vitiligo Impact Scale (VIP) [ Time Frame: Month 8 ]
    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

  13. Evaluation of blood inflammatory markers using immunofluorescence on skin biopsies and ELISA multiplex. [ Time Frame: Day 1 ]
    Epression of MxA CD3, CD4, CD8, CXCR3, CCR6, CXCL9, 10, 11, CCL20 et HSP70

  14. Evaluation of skin inflammatory markers using immunofluorescence on skin biopsies and ELISA multiplex. [ Time Frame: Day 1 ]
    Expression of IFN-α, TNF-α, IFN-γ, IL-17, IL-22, CXCL4, CXCL9, CXCL10, CXCL11, CXCL12, CXCL16, CCL20, HSP70 soluble



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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 <3G/L
  • Neutrophil count < 1.5 G/l
  • Lymphocytes count < 0.5G/l
  • Platelet count < 100 G/l
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT)>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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04237103


Contacts
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Contact: Julien SENESCHAL, MD, PhD +335 56 79 49 63 julien.seneschal@chu-bordeaux.fr
Contact: Sitraka RASOLOFO +335.56.82.06.55 sitraka.rasolofo@chu-bordeaux.fr

Locations
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France
Service de Dermatologie - Hôpital Saint-André
Bordeaux, France, 33075
Contact: Julien SENESCHAL, MD    +33 (0)5 56 79 47 05    julien.seneschal@chu-bordeaux.fr   
Sub-Investigator: Alain TAIEB, Prof         
Principal Investigator: Julien SENESCHAL, MD         
Centre Hospitalier de Pau
Pau, France, 64000
Contact: Thomas JOUARY, MD    +335 59 72 67 96    thomas.jouary@ch-pau.fr   
Principal Investigator: Thomas JOUARY, MD         
Centre Hospitalier de Périgueux
Périgueux, France, 24000
Contact: Jérôme MARIE, MD    +335 53 45 26 43    jerome.marie@ch-perigueux.fr   
Principal Investigator: Jérôme MARIE, MD         
Service de Dermatologie - CHU de Toulouse - Hopital Purpan
Toulouse, France, 31059 Toulouse Cedex
Contact: Carle PAUL, Pr.    33 (0) 5 61 77 76 75    paulc@chu-toulouse.fr   
Principal Investigator: Carle PAUL, Pr.         
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
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Principal Investigator: Julien SENESCHAL, MD, PhD University of Bordeaux
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT04237103    
Other Study ID Numbers: CHUBX 2017/44
First Posted: January 23, 2020    Key Record Dates
Last Update Posted: March 30, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Informed Consent Form (ICF)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Bordeaux:
vitiligo
pigmentation
phototherapy
methotrexate
Additional relevant MeSH terms:
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Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors