Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

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

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

8 criteria

  • 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 trial?

3 criteria

  • 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.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

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.

What is already known about the treatment

Cyclosporine – Cyclosporine is administered orally in the form of capsules or liquid solution and is used to treat moderate to severe atopic dermatitis in adults, adolescents, and children. It is a well-established medication in the medical field, with ongoing research to optimize its use through predictive models. The main therapeutic use of cyclosporine is to reduce inflammation and suppress the immune system's overactivity, which helps alleviate symptoms of atopic dermatitis. At the molecular level, cyclosporine works by inhibiting a protein called calcineurin, which in turn reduces the activity of T-cells, a type of immune cell involved in inflammation. It is classified as an immunosuppressant drug.

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-500677-14-00Protocol codeDermAtOmicsEstimated enrolment100 patientsSponsorFundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.