This Study is a Non-interventional Disease Registry of Adolescent and Adult Patients With Atopic Dermatitis Who Initiate or Switch Any Systemic Treatment
Study of Long-Term Real-World Systemic Treatments for Atopic Dermatitis
Study Overview
The objectives of this prospective non-interventional study are to characterize the existing unmet needs across the spectrum of atopic dermatitis (AD), enhance the understanding of the patient journey, and evaluate the safety and clinical outcomes of systemic AD treatments in a real-world setting. Additionally, patient-specific factors (such as age, skin color, AD flare triggers, previous treatment responses, comorbid conditions, and the extent and site of lesions) will be assessed to better characterize the impact on the treatment journey across a broad age range and diverse geographic regions.
The study will be conducted across 10 countries in 4 different geographical regions, with a follow-up period of 5 years.
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
- Conditions: Atopic Dermatitis
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Age: 12 years or above
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Gender: All
Inclusion Criteria:
- Patients aged more than or equal to (≥) 12 years at the time of consent.
- Confirmed diagnosis of AD, of any severity, according to the Investigator's assessment as aligned with International Classification of Diseases 10th revision (ICD-10) code of L20.
- Prescribed and scheduled to initiate any systemic treatment for AD (including but not limited to biologics, oral Janus kinase (JAK) inhibitors, cyclosporine, azathioprine, methotrexate, mycophenolate mofetil)
- Signed informed consent for registry participation by the patient or parent/legal representative and assent by the patient appropriate to the patient's age, including willingness to participate in long-term follow-up.
Exclusion Criteria:
- Concurrent participation in an interventional clinical trial that administers an investigational drug that modifies patient care.
- Insufficient understanding of the study by the patient and/or parent/guardian.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
The purpose of this research study is to learn about the long-term safety and clinical outcomes of systemic (whole-body) treatments for atopic dermatitis (eczema) in a real-world setting. The study will also collect information about patients’ experiences and treatment journeys, including factors that may affect flares and treatment response.
Participants will receive systemic treatment for atopic dermatitis that their regular doctor has already prescribed. The study will follow participants over time and collect information such as age, skin color, triggers for eczema flares, other health conditions, and where and how much skin is affected.
Who can participate:
People with atopic dermatitis may be able to participate if they:
- Are age 12 or older
- Have a confirmed diagnosis of atopic dermatitis (any severity)
- Are prescribed and scheduled to start a systemic treatment for atopic dermatitis
- Are not currently in another study where an investigational drug would change their medical care
Study timeline and visits:
Participation lasts 5 years.
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