RecruitingOBSERVATIONAL

French Prospective Observational Study in Patients Eligible for Systemic Therapy for Atopic Dermatitis (AD)

This French study is observing how adults (18 years and older) with moderate to severe eczema (atopic dermatitis) are managed when they need or are already taking stronger, whole-body medications. Doctors will follow patients for one year as part of their usual care. The aim is to understand how these treatments are used in everyday practice and how they affect patients. It’s not testing a new drug; rather, it’s collecting information on existing treatment choices made by doctors and how patients experience them. The study hopes to gather valuable insights into the real-world use of these important eczema treatments.

At a glance

Status

Recruiting

Sponsor

Sanofi

Enrolment target

600

Start

04 Feb 2025

Estimated completion

13 May 2027

Atopic Dermatitis

What is this study about?

This study aims to understand how doctors in France treat adults aged 18 and over who have moderate to severe eczema, also known as atopic dermatitis. Eczema can be a really challenging condition, and sometimes topical treatments (creams and ointments) aren't enough. When this happens, doctors might consider stronger medicines that work throughout the body, known as systemic therapies.

The study isn't testing a new medicine or asking doctors to change how they treat their patients. Instead, it's observing what's already happening in dermatology clinics. Doctors who specialise in eczema, both in hospitals and private practices, will invite suitable patients to take part. For a full year, these patients will have their usual appointments and assessments, and the study will collect information on their treatment choices and how they're doing.

The goal is to get a clearer picture of how these whole-body eczema treatments are used in real life. This information can help healthcare professionals and researchers better understand the treatment pathways for patients with more severe eczema, ultimately helping to improve care.

Key takeaways

This study observes real-world treatment of moderate to severe eczema.
It involves adults aged 18 and over in France.
You will continue to receive your usual medical care for one year.
No new medicines are given; your doctor makes all treatment decisions.
Your participation helps improve understanding of eczema treatments.
You are free to leave the study at any point.

Who may be eligible?

You might be able to join this study if you are 18 years or older and have eczema (atopic dermatitis) that your doctor thinks is moderate to severe. This could mean you are already taking a strong, whole-body medicine for your eczema, or your doctor feels you are now ready for one because your eczema is not well controlled with other treatments, or you use a lot of creams and ointments.

You also need to be able to understand and fill out simple questionnaires related to the study. It's important that you don't have any serious health problems that would make it difficult for you to attend your regular check-ups, and you shouldn't be involved in another clinical trial at the same time.

However, you won't be able to join if you're taking a whole-body medicine for a condition other than eczema, if you're involved in another clinical trial, or if you have certain legal or cognitive difficulties that would prevent you from taking part properly.

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?
Does your doctor consider your eczema to be moderate to severe?
Are you either taking, or potentially eligible for, strong whole-body medicines for your eczema?
Can you understand and fill out simple forms or questionnaires?
Are you not currently involved in another clinical trial?
Do you not have any other serious health issues that would prevent you from attending regular appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part, your medical care for your eczema will continue as normal. You will attend your regular doctor's appointments over a period of one year. There won't be any extra visits specifically for the study. During these visits, the doctors will simply record information about your general health, how your eczema is doing, and any treatments you are receiving. You will also be asked to complete some questionnaires about your eczema and how it affects your daily life. Your doctor will make all decisions about your treatment, completely separate from your involvement in this study. The total duration of your participation will be one year.

Potential risks and benefits

Taking part in this study doesn't involve any changes to your treatment or exposure to new drugs, so there are no direct medical risks from participating. Your doctor will continue to manage your eczema as they normally would. The potential benefit is that the information collected about your journey with eczema and its treatment will help improve our understanding of how to best manage this condition for other patients in the future. You are free to withdraw from the study at any time, for any reason, without it affecting the quality of your medical care.

Locations (62)

Investigational Site Number: 2500051
Verified postcode
Aix-en-Provence, France· Recruiting
Investigational Site Number: 2500023
Verified postcode
Amiens, France· Recruiting
Investigational Site Number: 2500004
Verified postcode
Angers, France· Recruiting
Investigational Site Number: 2500017
Verified postcode
Angers, France· Recruiting
Investigational Site Number: 2500050
Verified postcode
Arès, France· Recruiting
Investigational Site Number: 2500063
Verified postcode
Arès, France· Recruiting
Investigational Site Number: 2500054
Verified postcode
Bayonne, France· Recruiting
Investigational Site Number: 2500043
Verified postcode
Bezannes, France· Recruiting
Investigational Site Number: 2500040
Verified postcode
Biarritz, France· Recruiting
Investigational Site Number: 2500036
Verified postcode
Bordeaux, France· Recruiting
Investigational Site Number: 2500053
Verified postcode
Bordeaux, France· Recruiting
Investigational Site Number: 2500013
Verified postcode
Chalon-sur-Saône, France· Recruiting

Common questions

What is the main goal of this study?

To observe how adults with moderate to severe eczema are treated with stronger medicines in real-life medical practice in France.

Will I receive new medicine in this study?

No, this study is about observing existing treatments. Your doctor will decide your treatment, not the study.

How long will I be in the study?

You will be followed for one year as part of your usual medical appointments.

Do I have to do extra visits for the study?

No, the study will gather information during your routine doctor's visits for your eczema.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time without your medical care being affected.

How to find out more

Trial Transparency email recommended (Toll free for US & Canada)

contact-us@sanofi.com 800-633-1610 Official trial record

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