This Study is a Non-interventional Disease Registry of Adolescent and Adult Patients With Atopic Dermatitis Who Initiate or Switch Any Systemic Treatment
Study on Treatments for Atopic Dermatitis in Teens and Adults
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.
This study investigates atopic dermatitis (AD) in adolescents and adults who are starting or changing systemic treatments. The purpose of this study is to understand the needs of patients with AD and to learn more about their experiences with the condition.
The study aims to evaluate the safety and outcomes of treatments for AD in real-world settings. It will also look at various factors like age, skin color, and treatment history to see how they affect the treatment experience.
- Who can participate: Individuals aged 12 and older with a confirmed diagnosis of atopic dermatitis are eligible. Participants must be starting a systemic treatment for AD and willing to engage in long-term follow-up.
- Study details: Participants will be observed while receiving their usual care for atopic dermatitis. An observational study is a type of research study where data is collected by observing participants receiving routine care, without changing their treatment, which may focus on people using specific medications or having certain conditions to better understand how treatments work.
- Study timelines: The study will last 5 years.