AuthorisedTherapeutic use (Phase IV)Interventional

AliCsa; Efficacy of oral alitretinoin versus oral cyclosporine in patients with moderate to very severe hand eczema. A randomized prospective open-label trial with blinded outcome assessment

This study, called AliCsa, is looking at how well two treatments, alitretinoin and ciclosporin, work for people with moderate to very severe hand eczema. Both medicines are already approved for use, so this study aims to see which one is more effective and safer in real-world use over 24 weeks. Researchers will compare how much the hand eczema improves and how this affects the quality of life for those taking part. They will also keep a close eye on any side effects. This research helps doctors understand the best ways to treat hand eczema.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Universitair Medisch Centrum Groningen

Enrolment target

Start

08 Nov 2024

Hand eczema

What is this study about?

If you suffer from moderate to very severe hand eczema, you know how uncomfortable and disruptive it can be. This study, called AliCsa, is designed to compare two medicines, alitretinoin and ciclosporin, that are already available to treat this condition. The goal is to see which of these two treatments works better for improving hand eczema over 24 weeks.

Researchers will carefully look at how much your hand eczema improves, not just by looking at your skin, but also by asking about your quality of life. This means they want to understand how your eczema affects your daily activities and wellbeing. They'll also measure how quickly the treatments start to work and how long the improvements last. All of this information helps doctors make better decisions about which treatment to recommend.

The study also pays close attention to safety. Researchers will record any side effects you might experience, as this is an important part of understanding how well a treatment truly works. By comparing these two medicines in a structured way, the study aims to provide clear evidence to help patients and their doctors choose the most effective and tolerable treatment for hand eczema.

Key takeaways

Compares two existing medicines for hand eczema: alitretinoin and ciclosporin.
Aims to find out which medicine works more effectively and safely.
Lasts for 24 weeks, with regular check-ups.
Measures both skin improvement and impact on quality of life.
For adults (18+) with moderate to very severe hand eczema.

Who may be eligible?

This study is looking for adult volunteers, aged 18 years or older, who have hand eczema. Both men and women are welcome to take part. There isn't an upper age limit mentioned, so older adults with hand eczema might also be able to join.

To be eligible, you would need to have hand eczema that is considered moderate to very severe. The study doctors will carefully check your hand eczema to make sure it fits these criteria. If you have other serious health conditions or are taking certain medications, you might not be able to participate, but the study team will discuss all the details with you.

Quick self-check

Are you 18 years old or older?
Do you have moderate to very severe hand eczema?
Are you able to attend regular clinic visits?
Are you willing to take study medication?
Do you understand that you might receive one of two different treatments?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you would be given either alitretinoin or ciclosporin to take by mouth. The study is planned to last for 24 weeks, which is about six months. During this time, you would have regular visits to the clinic so that doctors can check how your hand eczema is responding to the treatment.

At these visits, doctors would assess your skin, ask you questions about how you feel, and discuss any side effects you might be experiencing. They will use different tools, like photographic guides and questionnaires, to measure your hand eczema's severity and how it's affecting your daily life. The aim is to track your progress from the beginning (called 'baseline') through to the end of the 24-week treatment period.

Potential risks and benefits

Taking part in this study could potentially offer you improved hand eczema symptoms and quality of life, as both medicines are known to be effective for some people. However, like all medicines, alitretinoin and ciclosporin can have side effects, which the study team will monitor closely and discuss with you. There's also no guarantee that either treatment will work for your specific condition. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
Netherlands

Common questions

What is hand eczema?

Hand eczema is a condition that causes red, itchy, dry, and sometimes cracked or blistered skin on your hands.

What are alitretinoin and ciclosporin?

These are two medicines that doctors sometimes prescribe to treat severe eczema, including on the hands. They both work in different ways to reduce inflammation and symptoms.

How long will the study last?

The treatment period for this study is 24 weeks, which is about six months.

Will I know which medicine I'm taking?

Yes, this is an 'open-label' study, which means both you and the study team will know which medicine you are receiving.

Are there any costs involved for me?

Clinical trials usually cover the cost of study-related medication and tests, but it's always best to confirm with the study team.