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Study on the Effectiveness and Safety of Methotrexate Compared to Placebo for Adults with Moderate to Severe Atopic Dermatitis

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What is this trial about?

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

This clinical trial is focused on studying the effectiveness and safety of a medication called methotrexate in treating adults with atopic dermatitis, which is a condition that causes the skin to become red, inflamed, and itchy. The study will compare the effects of methotrexate, given as a subcutaneous injection (an injection under the skin), to a placebo. The main goal is to see if methotrexate can improve the condition by at least 75% after 16 weeks of treatment.

Participants in the study will receive either methotrexate or a placebo for a period of up to 24 weeks. The study will involve regular visits to monitor the participants' health and the condition of their skin. The trial will assess various aspects of the skin condition, including the severity and area affected, using a tool called the Eczema Area and Severity Index (EASI). The study will also monitor any side effects or adverse reactions that may occur during the treatment period.

The trial aims to provide valuable information on whether methotrexate is a superior treatment option for moderate to severe atopic dermatitis compared to a placebo. This information could help in developing better treatment strategies for individuals suffering from this chronic skin condition. Participants will be closely monitored throughout the study to ensure their safety and well-being.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant is required to provide signed informed consent, confirming understanding and agreement to comply with the study requirements.

    A baseline visit is conducted to confirm eligibility, including a diagnosis of moderate to severe atopic dermatitis and other criteria.

  2. Step 2

    Initial assessment

    An initial assessment is performed, including a chest X-ray if not done within the last 6 months, and a pregnancy test for women of childbearing potential.

    Participants must have been using a stable dose of topical emollient for at least 7 consecutive days prior to this visit.

  3. Step 3

    Treatment phase

    Participants are randomly assigned to receive either subcutaneous methotrexate or a placebo.

    Methotrexate is administered via subcutaneous injection. The dosage and frequency are determined by the study protocol.

  4. Step 4

    Follow-up visits

    Follow-up visits occur at Trial Week 4, Trial Week 8, Trial Week 12, and Trial Week 16 to monitor progress and assess the Eczema Area and Severity Index (EASI) and other scores.

    Participants are evaluated for any adverse events or changes in health status.

  5. Step 5

    Final assessment

    At Trial Week 16, a final assessment is conducted to determine the primary endpoint, which is the EASI 75 response.

    Secondary endpoints include changes in various health and quality of life scores.

  6. Step 6

    Extension phase

    Participants may be eligible for an extension phase, with additional assessments at Trial Week 24.

    The extension phase includes further monitoring of health outcomes and any serious adverse reactions.

Who can join the trial?

10 criteria

  • You must be an adult, which means you are 18 years or older.
  • You need to have health care insurance as required by local rules.
  • If you are a woman who can have children, you must have a negative pregnancy test before starting and agree to use very effective birth control methods while taking the study medication and for 6 months after. Men must agree to use a condom during this time and not donate sperm for at least 3 months after the last dose.
  • You must have been diagnosed with atopic dermatitis (AD), a skin condition, at least 12 months before the start of the study.
  • Your atopic dermatitis should be moderate to severe, which means certain scores related to your skin condition are met at the start of the study.
  • You should be eligible for systemic treatment, which means you have not responded well to certain creams or have used other treatments for atopic dermatitis in the past year.
  • You must have been using a stable dose of a skin moisturizer for at least 7 days before the study starts. Using more than one moisturizer is okay.
  • You need to have had a chest X-ray in the last 6 months that shows no important problems.
  • You must be able to give written consent, which means you agree to follow the study rules and understand what is involved.
  • You should be willing and able to follow the study requirements for the entire duration of the trial.

Who cannot join the trial?

10 criteria

  • Having any other skin condition that might interfere with the study results.
  • Having a history of severe allergic reactions to any of the study medications.
  • Being pregnant or breastfeeding.
  • Having a serious illness that could affect participation in the study.
  • Using certain medications that might interfere with the study treatment.
  • Having a history of alcohol or drug abuse.
  • Having participated in another clinical trial recently.
  • Having a known infection that could affect the study results.
  • Having a condition that affects the immune system, which is the body's defense against illness.
  • Having a history of cancer, except for certain types of skin cancer.
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Investigated drugs

Methotrexate: This medication is used in the trial to treat moderate to severe atopic dermatitis. It is administered as an injection under the skin. The goal is to see if methotrexate can significantly improve the symptoms of eczema, such as reducing the area and severity of the skin condition, compared to not using any active medication.

What is already known about the treatment

Methotrexate – Methotrexate is administered subcutaneously, meaning it is injected under the skin. It is currently being studied in clinical trials for its effectiveness in treating moderate to severe atopic dermatitis. The main therapeutic indication for methotrexate in this context is to reduce the severity of eczema symptoms. At the molecular level, methotrexate works by inhibiting the enzyme dihydrofolate reductase, which is crucial for DNA synthesis and cell replication, thereby reducing inflammation. It is classified as an antimetabolite and immunosuppressant.

Investigated diseases

Atopic Dermatitis – Atopic dermatitis, commonly known as eczema, is a chronic skin condition characterized by inflamed, itchy, and red patches of skin. It often begins in childhood but can occur at any age. The disease progresses through cycles of flare-ups and remissions, where symptoms can worsen and then improve or clear up. The skin may become dry, cracked, and prone to infections due to frequent scratching. Environmental factors, allergens, and stress can trigger or exacerbate symptoms. Over time, the skin may thicken and become more leathery due to persistent scratching and irritation.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504443-13-00Protocol codeMC-MTX.18/ADEstimated enrolment304 patientsSponsorMedac Gesellschaft fuer klinische Spezialprapaerate mbH

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