In short
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.
Key points
- Clinical trials of Alitretinoin in the provided data focus on people with moderate to very severe hand eczema. The main study is a Phase 3 interventional trial with 78 participants. It compares Alitretinoin with cyclosporine in a randomized, prospective, open-label design with blinded outcome assessment. The key endpoint is the difference in treatment response from baseline to 24 weeks. This research is aimed at understanding which treatment works better for this skin condition.
Trial overview
The provided clinical trial data describe one interventional study of Alitretinoin in people with moderate to very severe hand eczema. The study title says it compares oral Alitretinoin with oral cyclosporine to see how well the treatments work in this skin condition.
The trial is listed as Authorised and includes 78 participants. Its brief summary states that the goal is to compare the efficacy, which means how well the treatment works, of Alitretinoin and cyclosporine.
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. It is described as a randomized prospective open-label trial with blinded outcome assessment.
Randomized means people are assigned to treatment groups by chance. Prospective means the researchers follow patients forward in time after they join the study. 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.
Who can participate
The trial data show that the target population is people with moderate to very severe hand eczema. No other eligibility details are given in the provided source, so the main known requirement is the condition being studied.
Hand eczema is a skin problem that affects the hands and can cause major discomfort and damage to the skin barrier. In this trial, the focus is on patients whose symptoms are serious enough to be classed as moderate to very severe.
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. Baseline means the starting point before treatment begins.
This endpoint asks whether one treatment group improves more than the other over 24 weeks. The study is therefore designed to measure treatment response over time, not just whether patients start treatment.
The trial compares Alitretinoin with cyclosporine, so the main question is which treatment gives better improvement for hand eczema in this patient group.
Why this trial matters
People with moderate to very severe hand eczema may need treatments that can reduce symptoms and improve daily life. 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.
The trial uses a blinded outcome assessment, which is helpful because it lowers the chance that expectations affect the result check. With 78 participants, the study is focused on a specific group of patients with a clear skin condition and a clear outcome measure.