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Microbiome in Atopic Dermatitis Under Systemic Therapy

This research study is for people in the UK with moderate to severe eczema (atopic dermatitis) who are starting a new type of treatment from their doctor, like a biologic or a JAK inhibitor. We want to understand how these new medicines affect the tiny living things (microbiome) on your skin. Scientists aren't sure if these changes cause eczema or happen because of it. By studying this, we hope to learn more about eczema itself and develop better ways to measure its severity and find new treatments. You would attend routine check-ups, and we'd take some blood and skin swab samples, which wouldn't involve any extra visits or painful procedures beyond your usual care.

At a glance

Status
Recruiting
Sponsor
Charite University, Berlin, Germany
Enrolment target
600
Start
01 Oct 2019
Estimated completion
31 Dec 2025

What is this study about?

This study is all about understanding eczema better, especially how new medicines for moderate to severe eczema affect the skin. Scientists are interested in the 'microbiome' – that's all the tiny living things, like bacteria, that naturally live on your skin. They want to find out if changes in these tiny living things cause eczema, or if eczema makes them change. It's a bit like trying to figure out if chickens came before eggs!

New medicines for eczema, such as biologics or JAK inhibitors, are becoming more common. This study aims to see if and how these new treatments affect the skin's microbiome. By learning more about these connections, we hope to develop new ideas about what causes eczema. This could also help doctors measure how severe your eczema is more accurately and, in the long run, lead to better, more targeted treatments for everyone with eczema.

Being part of this study means you'd be helping scientists gain a deeper understanding of this common skin condition. The information we gather could pave the way for future improvements in how eczema is managed and treated.

Key takeaways

  • This study helps understand how new eczema medicines affect skin bacteria.
  • It's for adults with moderate to severe eczema starting new systemic treatments.
  • Participation involves routine visits, blood tests, and a small skin swab.
  • No extra appointments or experimental medications are involved beyond your usual care.
  • Your contribution could lead to better eczema treatments in the future.
  • You can stop participating at any time without affecting your medical care.

Who may be eligible?

To join this study, you need to be an adult (18 years or older) who has moderate to severe eczema. This means your doctor has decided that you need a stronger type of treatment, often called a 'systemic therapy', to help manage your eczema.

There are a few reasons why you wouldn't be able to join. If you are under 18 when you start this new treatment, or if you are pregnant or breastfeeding, then this study isn't suitable for you. The study is designed for adults who are starting a specific type of eczema medication.

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.

  1. I am 18 years old or older.
  2. I have moderate to severe eczema.
  3. My doctor is planning to start me on a new 'systemic therapy' for my eczema.
  4. I am not pregnant or breastfeeding.
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be part of an 'observational study'. This means we'll be watching and learning from your journey without giving you any experimental medication. You won't need extra visits to the clinic; everything will happen during your usual routine check-ups with your doctor, which are typically every three months over two years. The key times for the study are before you start your new medication, and then at 6, 12, and 24 months after you start. If you begin a new treatment, we'll also invite you for a check-up six weeks later.

During these visits, we'll take a small blood sample. This is to check for certain markers in your blood related to inflammation and to look at your genes, which might give clues about your eczema. We'll also take a skin swab from your upper back (between your shoulder blades) to collect samples of your skin microbiome. This is a very quick and painless procedure. Your blood and skin samples will be given a code to protect your privacy and stored for up to five years after the study ends before being safely destroyed.

Potential risks and benefits

By taking part, you'll be contributing to a better understanding of eczema and how new treatments work, which could help future patients. You won't get any direct medical benefit from joining the study, but all tests are part of your routine care or are simple, non-invasive procedures. The main discomfort would be a quick prick when blood is taken. All your samples will be anonymised to protect your privacy. Remember, you can choose to leave the study at any time without giving a reason, and this won't affect your medical care.

Locations (1)

  • Dpt of Dermatology and Allergology, Charité - Universitätsmedizin Berlin
    Verified postcode
    Berlin, Germany· Recruiting

Common questions

What is the 'microbiome'?

The microbiome is made up of all the tiny living things, like bacteria, that naturally live on and inside your body, including your skin.

What does 'systemic therapy' mean?

Systemic therapy refers to medicines that work throughout your whole body, rather than just on the skin's surface, like creams. Examples include biologics or JAK inhibitors for eczema.

Will I have to take any new medicines as part of this study?

No, this is an observational study. You will continue to take the eczema medication prescribed by your doctor, but you won't be given any experimental medicines for the study itself.

How long will I be involved in the study?

Your involvement in the study will last for two years, aligning with your routine check-up visits every three months.

Will my information be kept private?

Yes, all your blood and skin samples will be given a code (pseudonymised) so your personal details are not directly linked to the samples. Your privacy is very important.

How to find out more

Margitta Worm, Prof

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

Interested in taking part?

Register your interest

Share your details and the research team for "Microbiome in Atopic Dermatitis Under Systemic Therapy…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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