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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.

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>medication administration</b>

    Take methotrexate (2.57 mg) as a tablet by mouth.

  2. Step 2

    <b>clinical monitoring</b>

    Clinical responses are assessed at 1, 3, 6, 9, 12, 15, and 18 months to determine if the condition is stable or if the disease is progressing.

    Side effects are documented using a questionnaire to evaluate safety and how well the medication is tolerated.

    Reports are provided regarding the reduction of vulvar complaints and the use of topical corticosteroids (creams applied to the skin).

  3. Step 3

    <b>pathology review</b>

    biopsies (small samples of tissue taken for examination) performed before, during, or after treatment are reviewed by a pathologist.

    Specialized staining is performed on the tissue samples to study the cellular environment of the dVIN (a type of skin change caused by lichen sclerosus).

Who can join the trial?

5 criteria

  • 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 trial?

13 criteria

  • 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.
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Investigated drugs

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.

What is already known about the treatment

Methotrexate - This medication is taken as a tablet by mouth and is a well-established treatment used to manage various inflammatory and autoimmune conditions. It belongs to a group of drugs called antimetabolites, which work by interfering with the way cells use folic acid to create DNA. By slowing down the rapid production of certain cells, it helps reduce inflammation and prevents the growth of abnormal tissue. In this study, it is being investigated for its ability to help prevent the return of skin changes associated with specific vulvar conditions.

Investigated diseases

  • 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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524373-17-00Protocol codeMERCURE524372Estimated enrolment30 patientsSponsorAmsterdam UMC Stichting

sourced from the EU Clinical Trials Register and site verification

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