RecruitingOBSERVATIONAL

Intervention With Tralokinumab in Patients With Moderate-to-severe Atopic Dermatitis With Genital Impact

This study is investigating a treatment called tralokinumab for adults who have moderate to severe eczema (atopic dermatitis) affecting their genital region. Eczema in this sensitive area can be particularly challenging, and this research aims to understand how well tralokinumab helps improve symptoms and patients' overall well-being. They will be looking at changes in participants' symptoms using special scoring systems and surveys, as well as non-invasive imaging techniques. The study involves 30 patients who are already starting tralokinumab as part of their regular care. Over 52 weeks, researchers will collect information during routine check-ups to see if this treatment makes a noticeable difference for people living with this specific type of eczema.

At a glance

Status

Recruiting

Sponsor

University Hospital Schleswig-Holstein

Enrolment target

Start

20 Oct 2025

Estimated completion

30 Jun 2028

Atopic Dermatitis (Moderate-to-severe) Involving the Genital Region

What is this study about?

This study is designed to understand how a medicine called tralokinumab works for people who have moderate to severe eczema, specifically when it affects their genital area. Eczema, also known as atopic dermatitis, can be very uncomfortable, and when it affects sensitive areas like the genitals, it can be particularly distressing and impact daily life. Tralokinumab is a treatment already used for eczema, but this study focuses on its effects on eczema in this specific body region.

The main idea behind this research is to see if tralokinumab can significantly improve the symptoms of genital eczema and help people feel better overall. The researchers will be using special ways to measure how severe the eczema is, as well as asking participants about their symptoms and quality of life through surveys. They also plan to use advanced non-invasive imaging techniques, which are like special cameras that can look at the skin without touching it, to track changes over time. By doing this, they hope to get a clear picture of how effective tralokinumab is for this specific type of eczema.

This is an important study because it focuses on a condition that can be very private and difficult to talk about, yet it significantly affects the lives of those who experience it. Understanding how tralokinumab helps in this specific area could lead to better treatment options and improved quality of life for many people.

Key takeaways

Focuses on tralokinumab for eczema affecting the genital area.
Aims to improve symptoms and quality of life.
Involves adults (18+) with moderate to severe eczema.
Participation involves routine check-ups over 52 weeks.
You would already be starting this treatment as part of your care.
Your medical care is not affected if you withdraw.

Who may be eligible?

To be part of this study, you need to be an adult (at least 18 years old). You must also have been diagnosed with moderate to severe eczema (atopic dermatitis) that affects your genital area. Importantly, you would already be starting treatment with tralokinumab because your doctor has decided it's the right course of action for you, based on standard guidelines, even before you consider joining the study.

There are also some reasons why you couldn't join. For example, if you are currently pregnant or breastfeeding, this study would not be suitable for you. Also, if you're already taking part in another study that involves new, unapproved medications, you wouldn't be able to join this one. Finally, if your eczema doesn't affect your genital area, this particular study isn't 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 moderate to severe eczema that affects your genital area?
Has your doctor already decided you should start treatment with tralokinumab?
Are you NOT pregnant or breastfeeding?
Are you NOT currently in another study testing a new, unapproved medicine?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be treated with tralokinumab as part of your normal care, following the usual instructions for the medication. Over 52 weeks (about a year), researchers will collect information during your regular doctor's visits. These visits are usually at the start of your treatment, then at weeks 4, 16, 24, and 52. During these visits, your doctor will assess your eczema using special scoring systems and you might fill out some questionnaires about your symptoms and how you're feeling. They may also use non-invasive imaging (like a special camera) to look at your skin. Your participation will mainly involve these routine check-ups and assessments, which are part of your ongoing care.

Potential risks and benefits

The potential benefit of taking part is that you'll receive treatment for your eczema, and your progress will be closely monitored, which could help your doctor fine-tune your care. While tralokinumab is an approved medication, like all medicines, it has potential side effects, which your doctor will discuss with you. You'll always have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

Department of Dermatology of the University Hospital Augsburg
Verified postcode
Augsburg, Germany· Recruiting
CCIM, Institut für Entzündungsmedizin UKSH Lübeck
Verified postcode
Lübeck, Germany· Recruiting

Common questions

What is tralokinumab?

Tralokinumab is a medicine used to treat eczema (atopic dermatitis).

Will I get a new medicine if I join the study?

No, you will be receiving tralokinumab as part of your regular medical treatment, not as an experimental drug within the study.

How long will the study last?

The study will follow your progress for about 52 weeks, or one year.

Do I have to go to extra appointments for this study?

The information for the study will be collected during your routine doctor appointments for your eczema treatment.

What are 'non-invasive imaging techniques'?

These are special ways to look at your skin, like using a camera, without actually touching or harming it.

How to find out more

Inga Brouer

ingacatharina.brouer@uksh.de +4945150041626 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.