Study on Methotrexate and Phototherapy for Adults with Progressive Vitiligo

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What is this study about?

This clinical trial is focused on studying the effectiveness and safety of a treatment for vitiligo, a condition that causes patches of skin to lose their color. The study involves a combination of two treatments: methotrexate, a medication often used to treat certain autoimmune diseases, and a type of light therapy called UVB TL01 phototherapy. The purpose of the study is to evaluate how well this combination works in helping the skin regain its color in adults with progressive vitiligo, which means the condition is getting worse or spreading.

Participants in the study will receive either the combination of methotrexate and UVB TL01 phototherapy or a placebo. The study will last for about eight months, during which the participants will be monitored to see how much of their skin regains color. The study will also assess the safety of the treatment by checking for any side effects. The main goal is to see the percentage of skin that repigments, or regains color, in those receiving the combination treatment.

Throughout the study, various assessments will be conducted to measure changes in skin color and quality of life. These assessments will include the VASI score, which measures the extent of skin repigmentation, and the DLQI score, which evaluates the impact of skin conditions on daily life. Blood and skin samples will also be taken to check for any changes in inflammation. The study aims to provide valuable information on whether this combination treatment can be an effective option for people with vitiligo.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a diagnosis of non-segmental vitiligo with new or expanding lesions in the last 6 months.

A Wood’s lamp examination is performed to identify specific skin changes. Eligibility also requires a body surface area affected by vitiligo of at least 10%.

2 medication administration

The treatment involves taking methotrexate orally at a dose of 15 mg per week. This medication is used in combination with UVB TL01 phototherapy.

The treatment aims to evaluate the repigmentation of the skin over an 8-month period.

3 phototherapy sessions

Regular sessions of UVB TL01 phototherapy are scheduled. The frequency and duration of these sessions are determined by the study protocol.

Phototherapy is used to enhance the effects of methotrexate in treating vitiligo.

4 midpoint evaluation

At 4 months, an evaluation is conducted to assess the reduction in the VASI score, which measures the extent of repigmentation.

Safety assessments of methotrexate and phototherapy are also performed at this stage.

5 final evaluation

After 8 months, a final evaluation is conducted to measure the primary endpoint, which is the reduction in the VASI score.

Secondary assessments include variations in the VETF score, F-VASI score, and the Dermatology Quality of Life Index (DLQI).

6 biological assessments

Blood and skin samples are collected at baseline, 2 months, 4 months, and 8 months to assess inflammatory parameters using ELISA tests.

These assessments help evaluate the biological effects of the treatment.

Who Can Join the Study?

Must be a male or female over 18 years old.
Must have a diagnosis of non-segmental vitiligo, which means the skin condition affects both sides of the body and covers at least 10% of the body surface.
Must have active non-segmental vitiligo, meaning there are new patches or the old patches have grown in the last 6 months. This should be confirmed by a special light examination called Wood’s lamp examination, which shows specific changes in skin color.
Must sign a document agreeing to participate in the study, known as an informed consent document.
Male participants must agree to use a reliable method of birth control, like condoms, during the study and for at least 6 months after the last dose of the study medication. If their partner is treated with methotrexate, she must be informed about the risk of birth defects and use effective contraception during the study and for at least 6 months after the last dose.
Women who can have children must test negative for pregnancy and agree to use a reliable method of birth control, like birth control pills, patches, intrauterine devices, or vaginal rings, every month or remain abstinent during the study and for at least 6 months after the last dose of the study medication.
Must be registered with the French Social Security system.

Who Cannot Join the Study?

Patients with vitiligo who have new spots or worsening of old spots in the last 6 months cannot participate. Vitiligo is a condition where the skin loses its color in patches.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country	Status
Centre Hospitalier De Perigueux	Perigueux	France
Centre Hospitalier De Pau	Pau	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	23.05.2023

Trial locations

Investigated drugs:

Methotrexate: This medication is used in the trial to help treat progressive vitiligo. It is taken by mouth once a week. Methotrexate is known to slow down the growth of certain cells, which may help in reducing the spread of vitiligo and promote repigmentation of the skin.

TL01 UVB Phototherapy: This is a type of light therapy used in the trial. It involves exposing the skin to ultraviolet B (UVB) light, which can help stimulate the skin’s pigment cells and encourage repigmentation in areas affected by vitiligo.

Investigated diseases:

Vitiligo

Vitiligo – Vitiligo is a skin condition characterized by the loss of pigment, resulting in white patches on various parts of the body. It occurs when the cells responsible for skin color, called melanocytes, are destroyed. The progression of vitiligo can vary, with some individuals experiencing rapid loss of pigment over a short period, while others may have a more gradual spread. New patches can appear, and existing ones may enlarge over time. The condition can affect any area of the skin, but it is more noticeable in areas exposed to the sun. The exact cause of vitiligo is not fully understood, but it is believed to involve genetic, autoimmune, and environmental factors.

Trial ID:

2024-512766-34-00

Protocol code:

CHUBX 2017/44

NCT ID:

NCT04237103

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Methotrexate and Phototherapy for Adults with Progressive Vitiligo

What is this study about?

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