Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Treatment of Chronic Hand Eczema with Oral Roflumilast (HERO) – a randomized controlled trial

The HERO study is a research project looking at a new oral medicine called roflumilast for people who suffer from chronic hand eczema – that's hand eczema that lasts a long time. The main goal is to find out if this new medicine can significantly reduce the severity of hand eczema. Some participants will receive roflumilast, while others will receive a placebo, which looks like the real medicine but contains no active ingredients. This helps researchers compare the effects fairly. We'll be checking participants' hand eczema symptoms and how much they improve after 16 weeks of treatment. This study is in an early stage (Phase II), meaning we're exploring how well it works.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Bispebjerg Hospital

Enrolment target

Start

20 Mar 2023

Chronic hand eczema

What is this study about?

This study, called HERO (which stands for "Treatment of Chronic Hand Eczema with Oral Roflumilast"), is all about finding better ways to help people living with chronic hand eczema. Chronic hand eczema is a common skin condition where your hands can become red, itchy, dry, and cracked for a long time. It can be really uncomfortable and impact everyday life.

The researchers want to see if a new medicine, taken by mouth, called roflumilast, can make a real difference. They will compare it to a 'placebo', which is a dummy pill that looks exactly like the study medicine but doesn't contain any active ingredients. This is a common and important way to test new medicines, as it helps us understand if any improvements are truly due to the medicine or other factors.

To measure how well the medicine works, the study will mainly look at whether people experience a significant improvement in their hand eczema after 16 weeks. This improvement is measured using a special scoring system for hand eczema. They will also look at other things like how much the eczema affects daily life, patients' overall quality of life, and what doctors observe about the eczema's severity.

Key takeaways

This study is for adults with chronic hand eczema.
It's testing a new oral medicine (roflumilast) against a dummy pill (placebo).
Participation involves regular clinic visits and taking daily medication for at least 16 weeks.
The main aim is to see if hand eczema significantly improves.
You will be closely monitored by medical professionals throughout the study.
Taking part is voluntary, and you can withdraw at any time.

Who may be eligible?

To be considered for this study, you need to be an adult, aged 18 or older. The study is open to both men and women.

The research team will need to check if you have chronic hand eczema that fits the study's specific criteria. This will likely involve a doctor reviewing your medical history and examining your hands to understand the type and severity of your eczema.

There might be other health conditions or medications that would prevent you from taking part, to ensure the study is safe and its results are clear. The study team will discuss all these details with you during an initial screening appointment to see if this study is right for you.

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 hand eczema that has been ongoing for a long time?
Are you able to attend regular appointments at a clinic?
Are you willing to take study medication (either active or placebo) as instructed?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll be randomly put into one of two groups: one group will take the new roflumilast medicine, and the other will take a placebo (a dummy pill). You won't know which one you're taking, and neither will your study doctor – this is to make sure the results are fair.

You'll need to attend several visits to the clinic over a period of 16 weeks, and potentially for a follow-up period afterwards. During these visits, the study team will carry out assessments to check your hand eczema, such as looking at the skin on your hands and asking you to fill out questionnaires about how you're feeling and how your eczema affects your daily life. They will also collect blood samples and perform health checks to monitor your safety. You will be provided with the study medication to take as instructed. The total duration of your participation in the study, including follow-up, will be explained to you in full detail by the study team.

Potential risks and benefits

Taking part in a clinical trial can have potential benefits, such as access to a new treatment that isn't widely available yet, and receiving close medical monitoring. However, there are also potential risks; the new medicine might cause side effects, or it might not help your condition. The placebo group won't receive the active drug, so their condition might not improve. You'll be given detailed information about all known and potential risks before you decide to join. Remember, taking part is entirely 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 (1)

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

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Unverified
Denmark

Common questions

What is chronic hand eczema?

It's a type of eczema that affects the hands and lasts for a long time, often causing redness, itching, cracks, and dryness.

What is a placebo?

A placebo is a dummy pill or treatment that looks exactly like the real medicine but doesn't contain any active ingredients. It's used to compare effects fairly.

How long will the study last?

The main treatment part of the study will last for 16 weeks, with additional follow-up visits meaning your participation could be longer. The study team will explain the exact duration.

Will I know if I'm getting the active medicine?

No, this is a 'blinded' study. To keep the results fair, neither you nor the study doctors will know if you're taking the active medicine or the placebo.

What if I want to stop taking part?

You have the right to leave the study at any time, for any reason, without needing to explain why. It will not affect your future medical care.