Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2, Double-Blind, Randomized, 16-Week, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream Followed by an Open-Label Extension Period in Adults With Chronic Hand Eczema

This research study is looking into a new cream, called ruxolitinib, to treat chronic hand eczema in adults. 'Chronic' means the eczema has been bothering them for a long time. The study will last 16 weeks and will compare the new ruxolitinib cream to a 'vehicle cream,' which is a dummy cream that looks and feels the same but doesn't contain any active medicine. This helps researchers understand if the ruxolitinib cream is truly working better than no active treatment. After the initial 16 weeks, participants will have the option to continue in an 'open-label' period, where everyone receives the ruxolitinib cream. The main goal is to see how many people get significant improvement in their hand eczema and to check for any side effects.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Incyte Corp.

Enrolment target

Start

11 Sep 2023

Chronic Hand Eczema

What is this study about?

This study is all about finding new and better ways to treat chronic hand eczema, a condition where your hands are frequently affected by red, itchy, and sometimes painful patches. When you have 'chronic' eczema, it means it doesn't go away easily and often comes back.

The researchers are testing a new cream called ruxolitinib. They want to find out how effective it is at clearing up hand eczema and making it less bothersome. They also need to make sure it's safe to use and doesn't cause too many unwanted side effects. This study is in 'Phase 2,' which means it's an early but important step in developing new medicines. It focuses on figuring out the right dose and gathering clear information on how well the treatment works in a larger group of people with the condition.

To really understand if the ruxolitinib cream is making a difference, the study uses a 'double-blind, randomized, vehicle-controlled' approach. 'Double-blind' means neither you nor your study doctor will know if you are getting the ruxolitinib cream or the 'vehicle cream' (dummy cream). 'Randomized' means you will be put into one of these groups by chance, like flipping a coin. The 'vehicle cream' looks exactly like the ruxolitinib cream but doesn't have any active ingredients. This helps the researchers be very confident that any improvements noticed are due to the active medicine and not just the act of putting on a cream or other factors.

Key takeaways

This study evaluates a new cream (ruxolitinib) for chronic hand eczema.
It compares the new cream to a dummy cream to see if it's more effective.
The initial treatment period is 16 weeks, with an option for longer participation.
Information is collected on eczema improvement, skin pain, itching, and quality of life.
Safety is carefully monitored throughout the study.
Participation involves regular clinic visits and health checks.

Who may be eligible?

This study is looking for adult volunteers of any gender who are at least 18 years old. You must have chronic hand eczema, meaning you've had eczema on your hands for a while and it keeps coming back or is an ongoing problem.

There might be some specific health conditions or medications that would prevent you from taking part, to ensure your safety and that the study results are clear. For instance, if you have other serious health problems or are using certain medicines, you might not be able to join.

The research team will carefully review your medical history to make sure this study is a good fit for you. They will explain all the details and answer any questions you have about whether you can take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have ongoing or returning eczema on your hands?
Are you generally healthy enough to participate in a study?
Are you able to attend regular clinic appointments?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, your participation will involve a main treatment period of 16 weeks. During this time, you will apply either the ruxolitinib cream or a dummy cream to your hands. Neither you nor the study team will know which cream you are using. You will have regular visits to the clinic so the study team can check on your hand eczema, ask about your symptoms (like itching and pain), and monitor your general health. These visits will include checks on your vital signs (like blood pressure) and some blood tests.

After the initial 16 weeks, if you choose, you can enter an 'open-label extension period.' This means you would then know that you are receiving the ruxolitinib cream, and everyone in this extension period would get the active drug. The total duration of your involvement, including follow-up, could extend beyond the initial 16 weeks, depending on whether you join the extension period. The study will track how your eczema affects your daily life, mood, and ability to work, through questionnaires.

Potential risks and benefits

Taking part in a study like this might offer some potential benefits, such as receiving a new treatment for your hand eczema that might improve your symptoms. You will also be closely monitored by medical professionals. However, there are also potential risks; for example, the new cream might not work for you, or it could cause side effects like skin irritation. There's also the chance you might receive the dummy cream during the main 16-week period. It's important to remember that participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany
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Unverified
Poland

Common questions

What is 'chronic hand eczema'?

Chronic hand eczema means you have eczema on your hands that has been present for a long time, often coming and going, or that doesn't clear up easily.

What is a 'dummy cream'?

A dummy cream (also called a 'vehicle cream' or 'placebo') looks and feels just like the active medicine cream but doesn't contain any active ingredients. It helps researchers see if the real medicine is truly making a difference.

Will I know if I'm getting the real cream?

For the first 16 weeks, neither you nor your doctor will know if you're getting the active ruxolitinib cream or the dummy cream. This is called 'double-blind.' If you continue in the study after 16 weeks, you will know you are receiving the active cream.

What does a 'Phase 2' study mean?

Phase 2 means this is an earlier stage of testing a new medicine. It helps researchers find out if the medicine works well and is safe in a larger group of people, and to figure out the best dose.

How long will I be in the study?

The main part of the study is 16 weeks. You might have the option to continue for a longer period in an 'open-label extension' phase, where everyone receives the active cream.