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Alitretinoin

Clinical trials are studying Alitretinoin in people with moderate to very severe hand eczema. These studies aim to compare how well it works and how safe it is, often against another treatment. The target group is adults with this skin condition.

Table of contents

Clinical trial overview

The available trial for Alitretinoin is studying people with hand eczema, a skin condition that affects the hands.[1] The study is designed to compare Alitretinoin with cyclosporine in patients with moderate to very severe disease.[1]

Study design and phase

This is an interventional study, which means researchers give treatments and then measure the results.[1] It is a Phase 3 trial, so it is a later-stage study meant to test how well the treatment works in a real patient group.[1]

The trial is randomized and open-label, with blinded outcome assessment.[1] Randomized means patients are placed into groups by chance, open-label means the treatment is known, and blinded outcome assessment means the result checker does not know which treatment each patient received.[1]

Who can join the study

The trial targets patients with moderate to very severe hand eczema.[1] The source data do not give more detailed entry rules, but the study focus shows that it is meant for people whose hand eczema is significant enough to need active treatment.[1]

What the trial measures

The main endpoint is the between-group difference in response to treatment from baseline to 24 weeks.[1] In simple words, the study checks whether one treatment helps more than the other over 24 weeks.[1]

Baseline means the first measurement before treatment starts, and the 24-week time point shows how patients do after several months of treatment.[1]

Key details from the trial

The trial title says it compares oral Alitretinoin with oral cyclosporine in patients with moderate to very severe hand eczema.[1] The planned enrollment is 78 participants, and the status is Authorised.[1]

  • Alitretinoin: one of the two study treatments being compared.[1]
  • Ciclosporin / cyclosporine: the other treatment used for comparison in the trial.[1]
  • Oral: taken by mouth, as stated in the trial intervention list.[1]
  • Blinded outcome assessment: the person judging the outcome does not know which treatment was given, which helps make the results more fair.[1]

Patient-friendly terms

Hand eczema means eczema on the hands, which can be hard to live with because the hands are used all day.[1] Treatment response means how much the eczema improves after treatment.[1] Enrollment means the number of people planned for the study, which here is 78.[1]

Trial ID Phase Condition studied Status Enrollment
2024-515140-23-00 Phase 3 Hand eczema Authorised 78

FAQ

  • What is being studied in Alitretinoin trials? The main study compares Alitretinoin with cyclosporine in people with hand eczema. The goal is to see which treatment gives a better response over time.
  • Who can take part in these trials? The trial is for patients with moderate to very severe hand eczema. It focuses on adults who need treatment for this condition.
  • What phase is the Alitretinoin study? The study is in Phase 3. This means it is a later-stage trial that tests how well the treatment works in a larger group of patients.
  • Is the trial randomized? Yes. The study is randomized, which means participants are assigned to treatment groups by chance. It is also open-label, so the treatment is known, but the outcome is checked in a blinded way.
  • What result is the trial measuring? The main result is the difference in treatment response between the start of the study and 24 weeks later. This helps show how effective the treatment is over time.

Sperimentazioni cliniche in corso su Alitretinoin

  • Studio sull’efficacia di alitretinoina e ciclosporina nei pazienti con eczema alle mani da moderato a molto grave

    Arruolamento non iniziato

    1 1 1 1
    Farmaci in studio:
    Paesi Bassi

Glossario

  • Hand eczema: A skin condition that affects the hands and can cause redness, dryness, itching, cracking, or inflammation.
  • Moderate to very severe: This means the condition is strong enough to cause major symptoms and may need active treatment.
  • Randomized: Participants are placed into treatment groups by chance, not by choice. This helps make the comparison fair.
  • Open-label: Both the patient and the study team know which treatment is being given.
  • Blinded outcome assessment: The person checking the study results does not know which treatment the patient received. This helps reduce bias.
  • Phase 3: A later stage of clinical research that studies how well a treatment works and continues to monitor safety.
  • Interventional study: A trial where researchers give a treatment and then measure the results.
  • Response to treatment: How much the symptoms improve after treatment starts.
  • Baseline: The first measurement taken before treatment begins.
  • Enrollment: The number of people planned to join the study.

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