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Study on the Effectiveness and Safety of Cyclosporine and Methotrexate for Children and Adolescents 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 two medications, cyclosporine and methotrexate, in treating children and adolescents with moderate to severe atopic dermatitis, commonly known as eczema. Atopic dermatitis is a skin condition that causes red, itchy, and inflamed skin. The purpose of the study is to compare how well these two medications work and how safe they are for young patients with this condition.

Participants in the study will receive either cyclosporine or methotrexate over a period of 32 weeks. Ciclosporin is given as an oral liquid, while methotrexate is provided as an oral solution. The study will also include a placebo group to help understand the effects of the medications better. Throughout the study, participants will have regular check-ups to monitor their progress and any side effects they might experience. The study aims to see if there is a significant improvement in the skin condition of the participants by the end of the treatment period.

In addition to the main medications, the study will also involve the use of tacrolimus and mometasone furoate ointments, which are applied topically to the skin. These ointments are used to help manage symptoms and provide additional treatment options. The study will assess various aspects of the participants' skin condition, including the severity of eczema, the level of itching, and the overall quality of life related to their skin health. The goal is to gather comprehensive data on how these treatments can improve the lives of those affected by moderate to severe atopic dermatitis.

The research process

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

Step 1
Initial visit
During the initial visit, the participant will meet with the study team to confirm eligibility. This includes checking the diagnosis of moderate to severe atopic dermatitis and ensuring all inclusion criteria are met.
A pregnancy test will be conducted for females of childbearing potential. The participant will also be informed about the use of a single emollient provided by the study sponsor.
Step 2
Baseline assessment
The baseline assessment involves detailed evaluations of the skin condition using specific scoring systems like EASI (Eczema Area and Severity Index) and SCORAD (Scoring Atopic Dermatitis).
The participant will be instructed to avoid excessive sunlight exposure and to use only topical emollients for two weeks before starting the trial medication.
Step 3
Treatment phase
The treatment phase involves administering either cyclosporine or methotrexate orally. The specific dosage and frequency will be determined by the study team based on the participant's condition.
The participant will continue this treatment for a period of up to 32 weeks, with regular monitoring and assessments to track progress and any side effects.
Step 4
Follow-up visits
Follow-up visits will occur at scheduled intervals to assess the participant's response to treatment. These visits will include evaluations of skin condition, quality of life assessments, and monitoring for any adverse effects.
The participant will be asked to report any changes in symptoms or new health issues during these visits.
Step 5
End of treatment assessment
At the end of the treatment period, a comprehensive assessment will be conducted to evaluate the overall effectiveness and safety of the treatment.
The participant's skin condition will be re-evaluated using the same scoring systems as at baseline, and any remaining medication effects will be monitored.
Step 6
Post-treatment follow-up
After completing the treatment, the participant will have follow-up visits to monitor for any long-term effects and to ensure the stability of the skin condition.
These visits will help determine the duration of treatment benefits and any potential need for further medical care.

Who can join the trial?

11 criteria

The patient must be between 2 and 18 years old at the time of giving written consent to participate.
The participant and their parent(s) or legal guardian(s) must agree to use only one moisturizer provided by the study organizers during the trial.
The patient must be vaccinated according to national guidelines, with the last vaccination at least one month before the first dose of the study medication (8 weeks if it was a live vaccine).
The patient must have been diagnosed with moderate-to-severe atopic dermatitis at least 6 months before starting the study. This condition must be confirmed during the screening and initial visits.
The patient must be considered by a doctor as a candidate for systemic therapy (treatment that affects the entire body).
The patient's body weight must be within the normal range for their age and sex.
Both female and male participants can join. Those who have reached sexual maturity must agree to use contraceptives or commit to sexual abstinence during the trial and for 6 months after stopping the study medication. Females who can become pregnant must have a pregnancy test before starting the study.
Only topical moisturizers can be used by the patient within 2 weeks before the first dose of the study medication.
The participant and their parent(s) or legal guardian(s) must be willing and able to attend scheduled visits, follow the treatment plan, and undergo laboratory tests and other study procedures.
The participant and their parent(s) or legal guardian(s) must agree to avoid excessive exposure to natural or artificial sunlight during the trial.
Any other medications the participant is taking must be at stable doses for at least 2 weeks or 5 half-lives (whichever is longer) before the screening visit.

Who cannot join the trial?

10 criteria

Patients who do not have atopic dermatitis cannot participate. Atopic dermatitis is a skin condition that causes itchy and inflamed skin.
Patients who are not children or adolescents cannot participate. This study is only for young people.
Patients with mild atopic dermatitis cannot participate. The study is for those with moderate-to-severe conditions.
Patients who are not willing to follow the study procedures cannot participate.
Patients who have other skin conditions that might interfere with the study cannot participate.
Patients who are currently taking medications that might interfere with the study cannot participate.
Patients who have a history of allergic reactions to the study medications cannot participate.
Patients who have participated in another clinical trial recently cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have any other medical conditions that the study doctors think might make it unsafe for them to participate cannot participate.

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Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi
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Lodz, Poland

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Investigated drugs

Cyclosporine
is a medication that helps to reduce the activity of the immune system. In this trial, it is being used to see if it can help children and teenagers with moderate-to-severe atopic dermatitis, which is a skin condition that causes red, itchy, and inflamed skin. By calming down the immune system, cyclosporine may help to reduce the symptoms of this skin condition.
Methotrexate
is another medication that is being tested in this trial. It also works by affecting the immune system, but in a different way than cyclosporine. Methotrexate is often used to treat various conditions that involve inflammation, such as certain types of arthritis. In this study, researchers want to find out if methotrexate can help improve the skin condition of children and teenagers with moderate-to-severe atopic dermatitis by reducing inflammation and other symptoms.

What is already known about the treatment

Cyclosporine
Cyclosporine is typically administered orally in the form of capsules or liquid, and it is used to treat moderate-to-severe atopic dermatitis, a type of skin inflammation. In medical literature, cyclosporine is well-established as an immunosuppressant, meaning it helps reduce the activity of the immune system. It works by inhibiting a specific protein in immune cells, which decreases the production of substances that cause inflammation. Cyclosporine is classified as a calcineurin inhibitor, a type of medication that helps control immune responses.
Methotrexate
Methotrexate is usually taken orally in tablet form and is used to manage moderate-to-severe atopic dermatitis, a chronic skin condition. It is recognized in medical literature as a disease-modifying antirheumatic drug (DMARD), which means it can alter the course of inflammatory diseases. Methotrexate works by interfering with the growth of certain cells, including those of the immune system, by inhibiting an enzyme involved in cell division. This action helps reduce inflammation and control symptoms. Methotrexate is classified as an antimetabolite, a type of drug that disrupts cell metabolism.

Investigated diseases

Atopic Dermatitis – Atopic dermatitis is a chronic inflammatory skin condition characterized by dry, itchy, and red skin. It often begins in childhood and can persist into adulthood. The skin may become thickened and cracked due to persistent scratching. Flare-ups can occur, leading to increased itching and discomfort. The condition is associated with a malfunction in the skin barrier and immune system, which can lead to increased sensitivity to irritants and allergens. Over time, the affected areas may change, and the severity of symptoms can vary.