A study to evaluate the effectiveness of methotrexate in preventing the recurrence of dermatological vulvar intraepithelial neoplasia in women with lichen sclerosus.

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What is this study about?

This study focuses on individuals with lichen sclerosus, a skin condition that can cause itching and changes to the skin, and dVIN, which is a type of skin cancer found in the vulvar area. The purpose of the study is to determine if a medication called methotrexate can help prevent the return of these skin cancer lesions. This research specifically looks at people who have already experienced recurring skin changes and have not responded well to other treatments.

Participants in the study may take methotrexate in the form of an oral tablet. During the course of the study, the condition of the skin will be monitored over several months to see if the disease remains stable or if it progresses. The research also aims to observe how well the medication is tolerated and if it helps reduce the need for topical corticosteroids, which are creams used to reduce inflammation. Additionally, biopsies, which involve taking a small sample of skin tissue for examination, may be used to study the changes in the skin cells through a process called immunohistochemistry, a method used to look for specific proteins like p53 in the tissue.

Who Can Join the Study?

You must be a woman aged 18 years or older.
You must have lichen sclerosus, which is a skin condition that causes itchy, white patches, and it must not be responding well to standard treatments.
Your condition must have not improved after using strong steroid creams like clobetasol ointment or creams combined with tacrolimus, which is a medication used to calm the immune system in the skin.
You must have had dVIN, which stands for differentiated vulvar intraepithelial neoplasia, a type of precancerous change in the skin cells, at least once before.
You must have already had surgery to treat your previous dVIN lesions.

Who Cannot Join the Study?

Having vulvar cancer, which is a type of cancer found on the external female genitals.
Not having enough knowledge of the Dutch or English language to understand the study instructions.
History of alcohol abuse.
Having ulcers (open sores) or stomatitis (inflammation or sores in the mouth) in the mouth or the digestive tract.
Having recently received, or needing to receive, a live attenuated vaccine, which is a type of vaccine that uses a weakened form of the germ.
Having severe decreased liver function, measured by a high level of bilirubin (a yellow substance in the blood produced by the breakdown of red blood cells).
Having severe decreased kidney function, measured by a low creatinine clearance (a test that shows how well the kidneys filter waste from the blood).
Having bone marrow diseases, which are conditions affecting the part of the body that makes blood cells; this includes leukopenia (low white blood cell count), thrombocytopenia (low platelet count), anemia (low red blood cell count), or bone marrow hypoplasia (when the bone marrow does not produce enough new blood cells).
Having acute or chronic infections, such as HIV/AIDS or tuberculosis (a serious infection that mainly affects the lungs).
Having an immunodeficiency (a weakened immune system) or using immunosuppressive medication (drugs that lower the body’s ability to fight infection).
Having severe pulmonary disease, which refers to serious illnesses affecting the lungs.
Being pregnant or currently wanting to become pregnant.
Being under legal incapability, meaning a person is not legally allowed to make their own decisions.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Catharina Ziekenhuis Stichting	Eindhoven	The Netherlands
Apiwcdmpe Upw	Amsterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not yet recruiting	01.03.2026

Trial locations

Investigated drugs:

Methotrexate

Methotrexate is a medication taken by mouth that is being studied to see if it can help prevent the return of vulvar intraepithelial neoplasia (dVIN) in women who have therapy-resistant lichen sclerosus.

Investigated diseases:

Lichen sclerosus

Lichen sclerosus – This is a chronic skin condition that most commonly affects the genital and anal areas. It often results in thin, white patches of skin that may feel itchy or uncomfortable. Over time, the skin can become scarred, hardened, or even develop small tears. The condition is characterized by changes in the skin’s texture and appearance.

Differentiated vulvar intraepithelial neoplasia – This is a condition involving abnormal cell growth on the surface of the vulva. It is often associated with other skin disorders like lichen sclerosus. As the condition progresses, the abnormal cells can change the appearance of the vulvar tissue. These cellular changes may become more widespread or distinct over time.

Trial ID:

2025-524373-17-00

Protocol code:

MERCURE524372

Trial Phase:

Therapeutic confirmatory (Phase III)

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A study to evaluate the effectiveness of methotrexate in preventing the recurrence of dermatological vulvar intraepithelial neoplasia in women with lichen sclerosus.

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?