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Study on Optimizing Ciclosporin Treatment for Moderate to Severe Atopic Dermatitis in Adults, Adolescents, and Children

3 1 1 1

What is this study about?

This clinical trial is focused on studying the treatment of atopic dermatitis, a condition that causes the skin to become red, itchy, and inflamed. The treatment being tested is called cyclosporin, which is an immunosuppressive medication. This means it helps to reduce the activity of the immune system, which can be beneficial in conditions like atopic dermatitis where the immune system is overactive.

The purpose of the study is to improve the use of cyclosporin in treating atopic dermatitis by identifying certain biological markers that can predict how well a patient will respond to the treatment. These markers include genetic, kinetic, and immunological factors. The study aims to develop a model that can help determine the best dosage and treatment plan for each patient based on these markers.

Participants in the study will receive cyclosporin in the form of soft capsules, which are taken orally. The study will monitor the participants over a period of time to see how their condition responds to the treatment. The goal is to find out how many patients show significant improvement in their symptoms and to understand the time it takes for the treatment to be effective. The study will also track any side effects experienced by the participants. This research hopes to provide better guidance for using cyclosporin in treating atopic dermatitis, making it more effective and tailored to individual needs.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, your eligibility for the trial will be confirmed. This involves reviewing your medical history and conducting a physical examination.

You will be asked to provide written informed consent, which means you agree to participate in the study after understanding all the details and potential risks.

2 baseline assessment

A baseline assessment will be conducted to record your current health status. This includes measuring the severity of your atopic dermatitis using various scales.

These scales include the EASI (Eczema Area and Severity Index), SCORAD (Scoring Atopic Dermatitis), IGA (Investigator Global Assessment), BSA (Body Surface Area), NRS (Numerical Rating Scale), DLQI (Dermatology Life Quality Index), and POEM (Patient Oriented Eczema Measure).

3 medication administration

You will begin treatment with ciclosporin, which is available in soft capsule form. The dosage will be determined by the study team based on your specific needs.

The medication is taken orally, and the frequency and duration will be explained to you by the study team. Regular follow-up visits will be scheduled to monitor your response to the treatment.

4 follow-up visits

You will attend regular follow-up visits to assess your response to the treatment. These visits will include evaluations using the same scales as the baseline assessment.

The primary goal is to achieve a 75% improvement in the EASI score by week 16. Additional assessments will be conducted at week 6 and throughout the study to monitor progress.

5 end of treatment evaluation

At the end of the treatment period, a final evaluation will be conducted. This will include a comprehensive assessment of your condition and any changes in the severity of your atopic dermatitis.

The study team will also review any side effects or adverse events experienced during the trial.

Who Can Join the Study?

  • Participants must be diagnosed with moderate-severe atopic dermatitis. This is a skin condition that causes itchy and inflamed skin.
  • For Cohort 1, participants should be planning to start treatment with cyclosporine. Cyclosporine is a medication used to suppress the immune system.
  • For Cohort 2, participants should be currently receiving or have received cyclosporine treatment in the past.
  • Participants must be willing and able to provide written informed consent before starting any study procedures. This means they agree to participate after understanding the study details.
  • For children, a parent or legal guardian must provide written informed consent. If the child is older than 11 years, they must also give their agreement, known as assent.
  • Participants must be willing and able to follow the procedures outlined in the study protocol.
  • The study is open to both male and female participants.
  • The study includes adults, adolescents, and children.

Who Cannot Join the Study?

  • Patients who are not diagnosed with moderate-severe atopic dermatitis cannot participate. This is a skin condition that causes itchy and inflamed skin.
  • Patients who are not within the specified age range cannot participate. The study is for adults, adolescents, and children.
  • Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care.

Where you can join this trial?

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Site Name City Country Status
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Not recruiting
30.06.2022

Trial locations

Investigated drugs:

Cyclosporin is a medication used in this clinical trial to treat atopic dermatitis, which is a type of skin condition that causes red, itchy, and inflamed skin. The goal of using Cyclosporin in this study is to find out how well it works for different people and to see if we can predict who will respond well to the treatment. Researchers are looking at various factors, like genetics and immune system markers, to help determine the best way to use Cyclosporin for each patient. This could help doctors decide the right amount and schedule for taking the medication, making the treatment more effective and personalized for those with atopic dermatitis.

Investigated diseases:

Atopic Dermatitis – Atopic dermatitis is a chronic inflammatory skin condition characterized by itchy, red, and swollen skin. It often begins in childhood but can occur at any age. The disease progresses through periods of flare-ups and remissions, where symptoms can worsen and then improve. The skin may become thickened and cracked over time due to persistent scratching. It is commonly associated with other allergic conditions such as asthma and hay fever. The exact cause is unknown, but it involves a combination of genetic, environmental, and immune system factors.

Trial ID:
2022-500677-14-00
Protocol code:
DermAtOmics
Trial Phase:
Therapeutic confirmatory (Phase III)

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