RecruitingOBSERVATIONAL

TREATgermany: German National Clinical Registry for Patients With Moderate-to-severe Atopic Dermatitis

TREATgermany is a study gathering information about people in Germany who have moderate-to-severe eczema (atopic dermatitis). Many adults, and even more children and teenagers, struggle with this condition, and sometimes skin creams aren't enough, requiring stronger medicines. This study isn't testing new treatments; instead, it's carefully observing and recording how patients are currently being treated and how their condition changes over time. Researchers want to truly understand what works best in everyday care, especially since stronger treatments are becoming available for younger patients. By collecting detailed information from patients and their doctors, this registry will help improve care for people with eczema in the future.

At a glance

Status

Recruiting

Sponsor

Technische Universität Dresden

Enrolment target

2,800

Start

01 Feb 2016

Estimated completion

31 Dec 2026

Moderate-to-severe Atopic Dermatitis

What is this study about?

This study, called TREATgermany, is creating a national registry in Germany for people who have moderate-to-severe eczema, also known as atopic dermatitis. Eczema is a common skin condition that can affect people of all ages, from babies and children to adults. When eczema is moderate to severe, it means that creams and lotions might not be enough to control it well, and people might need stronger medicines that affect the whole body, or special light treatments. The goal of this registry is to gather a lot of practical, real-world information about how people with this type of eczema are being treated and how their health changes over many months.

Even though many treatments exist, doctors don't always have clear, long-term information about which ones work best for whom, especially in children and teenagers. This registry will help fill these gaps by tracking how effective different treatments are in everyday medical care, looking at things like how much the eczema improves, how it affects a person's daily life, and any other health conditions they might have. The study will also help prepare for new medications that are expected to become available for younger patients in the coming years, by providing important background information.

In simple terms, TREATgermany won't be giving anyone new medicines or treatments. Instead, it's like keeping a very detailed diary of how people with eczema are cared for by their own doctors. This information will then be used to help doctors and healthcare providers make better decisions about treatment, improve guidelines, and ensure that people with eczema get the best possible care, tailored to their individual needs.

Key takeaways

It's a long-term study gathering real-world information about eczema care.
No new medicines or treatments are given; your usual care continues.
It aims to improve understanding of eczema treatments, especially for children and teens.
Participation involves sharing information through questionnaires and doctor reports.
The data collected will help create better treatment guidelines in the future.
You can withdraw from the study at any time without affecting your medical care.

Who may be eligible?

To be considered for this study, you would need to have eczema (atopic dermatitis) that has been diagnosed according to specific UK guidelines. Your eczema would need to be considered moderate to severe.

This means that either your eczema score (called Objective SCORAD) is above 20, or you are currently taking stronger medicines (called anti-inflammatory systemic treatments) for your eczema, or you have taken these stronger medicines for your eczema within the last two years. There are no other specific reasons listed that would prevent someone from joining the study.

Anyone of any age, male or female, who meets these criteria could potentially 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.

Do I have eczema (atopic dermatitis) diagnosed by a doctor?
Is my eczema considered moderate to severe?
Is my Objective SCORAD score over 20, or am I on, or have I recently been on, stronger eczema medicine?
Am I willing to share information about my health and treatment over time?

Answer every question to see your result.

What does participation involve?

If you join this study, you won't be given any new medications or treatments. Your current doctors will continue to treat you as they would normally. The study involves keeping track of your health over time, for at least 24 months (two years), but potentially longer. You'll have regular study visits, usually when you already see your doctor. The first visit is when you start the study. Then you'll have visits at 3 and 6 months after starting. After that, visits are scheduled every 3 months if you've started a new stronger medication, or every 6 months if you haven't. At these visits, your doctor will fill out a form about your eczema and your medical care. You will also fill out a form yourself, sharing how you feel, how your eczema affects your life, and how satisfied you are with your treatment. In some cases, with your separate permission, you might be asked to provide samples like blood, skin swabs, or stool, and even a skin biopsy, but this is optional.

Potential risks and benefits

Taking part in this study doesn't involve any new medical treatments, so there are no direct risks from new medications. The main commitment is your time for the visits and filling out questionnaires. A potential benefit is contributing to a better understanding of eczema, which could lead to improved care for others in the future. You also might feel more involved in your own health journey. You are completely free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (3)

Clinics for Dermatology, Allergy and Venerology, Hannover Medical School
Verified postcode
Hanover, Germany· Recruiting
Department of Dermatology, UniversityAllergyCenter, Medical Faculty Carl Gustav Carus, TU Dresden
Verified postcode
Dresden, Germany· Recruiting
Head Centre for Inflammatory Skin Diseases, Department of Dermatology and Allergy, University Hospital Schleswig-Holstein, Campus Kiel
Verified postcode
Kiel, Germany· Recruiting

Common questions

What is the main goal of the TREATgermany study?

The study aims to create a detailed record of how people with moderate-to-severe eczema are treated in Germany and how their condition changes over time, to improve future care.

Will I receive new medicine or treatment if I join?

No, the study doesn't involve any new treatments. You will continue to receive care from your own doctors as usual.

How long will I need to be in the study?

You'll be followed for at least 24 months (two years), but it could be longer.

What does a study visit involve?

Study visits involve your doctor completing a form about your eczema and you filling out a questionnaire about your feelings, quality of life, and treatment satisfaction.

Can children and teenagers join this study?

Yes, extending the study to include children and teenagers is an important part of TREATgermany.

How to find out more

Jochen Schmitt, Prof.Dr.

jochen.schmitt@uniklinikum-dresden.de +493514586493 Official trial record

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