Observational Evaluation of Atopic Dermatitis in Pediatric Patients
Study on 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 pediatric patients with moderate to severe atopic dermatitis (AD), a skin condition causing red, itchy patches. The purpose is to understand the characteristics of these patients whose condition is not well-managed with creams or when such treatments are not suitable. It also looks at how AD and related allergic conditions change over time.
Participants will undergo assessments to evaluate the burden of the disease and the treatment needs that are not met. The study will also observe how treatments are used in real life, including how often they are taken, how long they are used, and why they might be stopped or changed. The effectiveness and safety of these treatments will also be documented.
- Who can participate: Children with moderate to severe atopic dermatitis who are receiving or are candidates for systemic treatment may participate. They should not be involved in another clinical trial that changes their care.
- Study details: Participants will be observed for how they manage their atopic dermatitis, including any systemic treatments they are using. A placebo is not involved.
- Study Timelines: The study will last 120 months.
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