Combination of Methotrexate and Phototherapy Versus Phototherapy in Adults With Progressive Vitiligo

NCT04237103 | Completed Phase 2 DMC

• 2 other identifiers: CHUBX 2017/442018-004536-29
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 4

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.

Conditions

Vitiligo

Keywords

vitiligo; pigmentation; phototherapy; methotrexate

Outcome Measures

Primary Outcomes (1)

• 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.

  month 8

Secondary Outcomes (14)

• Score with VASI formule

  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

  Month 8

• Evaluation of score Vitiligo European Task Force (VETF)

  Month 4

• Evaluation of score Vitiligo European Task Force (VETF)

  Month 8

• Evaluation of score of the Vitiligo Extent Score (VES)

  Month 4

Study Arms (2)

methotrexate

EXPERIMENTAL

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

placebo

PLACEBO COMPARATOR

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

Interventions

Placebos DRUG

Administered identically to the experimental group

Also known as: narrow-band UVB phototherapy

placebo

Methotrexate DRUG

oral capsules taken once a week

Also known as: narrow-band UVB phototherapy

methotrexate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (4)

Service de Dermatologie - Hôpital Saint-André

Bordeaux, Bordeaux, 33075, France

Location

Centre Hospitalier de Pau

Pau, 64000, France

Location

Centre Hospitalier de Périgueux

Périgueux, 24000, France

Location

Service de Dermatologie - CHU de Toulouse - Hopital Purpan

Toulouse, 31059 Toulouse Cedex, France

Location

MeSH Terms

Conditions

Vitiligo

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Julien SENESCHAL, MD, PhD

  University of Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Methotrexate taken orraly once a weekcombination with UVB TL01 in a population of adult patients with progressive vitiligo

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: January 23, 2020
• Study Start: May 23, 2023
• Primary Completion: November 4, 2025
• Study Completion: November 4, 2025
• Last Updated: May 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

FR (4)