Observational Evaluation of Atopic Dermatitis in Pediatric Patients
Investigation of Atopic Dermatitis in Children
Study Overview
Primary Objectives:
- To describe the characteristics of pediatric patients with moderate to severe atopic dermatitis (AD) whose disease is not adequately controlled with topical therapies or when those therapies are not medically advisable.
- To evaluate the time-course of AD and selected atopic comorbidities.
Secondary Objectives:
- To characterize disease burden and unmet need.
- To describe real-world treatment patterns (eg, dosing regimens, treatment duration, and reasons for discontinuation and/or switching).
- To document the real-world effectiveness and safety of treatments.
Study Details
The study duration is 120 months.
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
- Conditions: Dermatitis Atopic
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Age: 11 years or below
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Gender: All
Inclusion criteria:
- Patients with moderate to severe AD, according to the Investigator's assessment;
- Currently receiving systemic treatment (including phototherapy) for atopic dermatitis or currently on topical treatment, but otherwise candidates for systemic treatment.
Exclusion criteria:
- Concurrent participation in an interventional clinical trial which modifies patient care.
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 children, focusing on those with moderate to severe cases that are not well-controlled with topical treatments or for whom these treatments are not suitable. The study aims to describe the characteristics of these patients and evaluate the progression of AD and related conditions over time.
Participants will be observed to understand the burden of the disease and the unmet needs in treatment. The study will also document real-world treatment patterns, including how treatments are administered, how long they are used, and why they may be stopped or changed. Furthermore, the study will assess the effectiveness and safety of these treatments in a real-world setting. 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.
- Who can participate: Children with moderate to severe atopic dermatitis who are either receiving systemic treatment or are candidates for it can participate. Those involved in other trials that change their care are not eligible.
- Study details: Participants will continue their usual care while researchers collect data on their condition and treatment. This study will not alter their current treatment plan.
- Study timelines: The study will last 120 months.
