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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 against other treatments and to measure treatment response and safety in a controlled research setting.

Table of Contents

Trial overview

The provided clinical trial data describe one interventional study of Alitretinoin in people with moderate to very severe hand eczema.[1] The study title says it compares oral Alitretinoin with oral cyclosporine to see how well the treatments work in this skin condition.[1]

The trial is listed as Authorised and includes 78 participants.[1] Its brief summary states that the goal is to compare the efficacy, which means how well the treatment works, of Alitretinoin and cyclosporine.[1]

Study design and phase

This study is a Phase 3 trial, which is a later stage of clinical research usually used to compare treatments in a larger patient group.[1] It is described as a randomized prospective open-label trial with blinded outcome assessment.[1]

Randomized means people are assigned to treatment groups by chance.[1] Prospective means the researchers follow patients forward in time after they join the study.[1] Open-label means the patients and study team know which treatment is being given, while blinded outcome assessment means the person checking the results does not know the treatment group, which helps make the results more fair.[1]

Who can participate

The trial data show that the target population is people with moderate to very severe hand eczema.[1] No other eligibility details are given in the provided source, so the main known requirement is the condition being studied.[1]

Hand eczema is a skin problem that affects the hands and can cause major discomfort and damage to the skin barrier.[1] In this trial, the focus is on patients whose symptoms are serious enough to be classed as moderate to very severe.[1]

What is being measured

The main endpoint, or main result the researchers want to measure, is the between-group difference in response to treatment from baseline to 24 weeks.[1] Baseline means the starting point before treatment begins.[1]

This endpoint asks whether one treatment group improves more than the other over 24 weeks.[1] The study is therefore designed to measure treatment response over time, not just whether patients start treatment.[1]

The trial compares Alitretinoin with cyclosporine, so the main question is which treatment gives better improvement for hand eczema in this patient group.[1]

Why this trial matters

People with moderate to very severe hand eczema may need treatments that can reduce symptoms and improve daily life.[1] This study is important because it directly compares two active treatments in a Phase 3 setting, which can help show how they perform against each other in real patient care research.[1]

The trial uses a blinded outcome assessment, which is helpful because it lowers the chance that expectations affect the result check.[1] With 78 participants, the study is focused on a specific group of patients with a clear skin condition and a clear outcome measure.[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 trials are testing whether Alitretinoin helps people with moderate to very severe hand eczema. One study compares it with cyclosporine to see which treatment gives a better response.
  • Who can take part in these trials? The main target group is patients with moderate to very severe hand eczema. Trial entry depends on the study rules, but the trial data show that this condition is the focus.
  • What phase is the Alitretinoin study? The trial listed is a Phase 3 study. Phase 3 studies usually compare treatments in a larger group of patients to find out how well they work.
  • What treatment is Alitretinoin being compared with? In the listed study, Alitretinoin is compared with cyclosporine. The study is designed to check which treatment gives a better improvement in hand eczema.
  • What outcome is the study measuring? The main outcome is the difference in response to treatment between the start of the study and 24 weeks. This means the researchers want to see how much patients improve over time.

Ongoing Clinical Trials on Alitretinoin

  • Study Comparing Alitretinoin and Ciclosporin for Patients with Moderate to Very Severe Hand Eczema

    Not yet recruiting

    1 1 1 1
    Investigated drugs:
    The Netherlands

Glossary

  • Hand eczema: A skin condition that affects the hands and can cause redness, itching, cracking, or scaling.
  • Moderate to very severe: This means the condition is more than mild and can cause major symptoms or discomfort.
  • Randomized: Participants are assigned to treatment groups by chance, not by choice.
  • Prospective: The study follows patients forward in time after they join the trial.
  • Open-label: Both the researchers and the patients know which treatment is being given.
  • Blinded outcome assessment: The person judging the results does not know which treatment the patient received, which helps reduce bias.
  • Phase 3: A later stage of clinical research that studies how well a treatment works in a larger group of patients.
  • Interventional study: A study where researchers give a treatment and then measure its effects.
  • Primary outcome: The main result the researchers are trying to measure.
  • Between-group difference: A comparison of results between two treatment groups.
  • Response to treatment: How much a patient's condition improves after treatment.

References

  1. https://clinicaltrials.gov/study/2024-515140-23-00