Observational Evaluation of Atopic Dermatitis in Pediatric Patients (PEDISTAD)

Study of Atopic Dermatitis (Chronic Skin Condition) in Children

Recruiting
11 years or below
All
Phase N/A
1845 participants needed
47 Locations

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
  • Age: 11 years or below
  • 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.

Updated on 23 May 2025. Study ID: NCT03687359

This study investigates atopic dermatitis (AD) in children, focusing on those with moderate to severe forms of the condition. Atopic dermatitis is a chronic skin condition characterized by itchy and inflamed skin. The study aims to understand the characteristics of these pediatric patients, especially when their condition is not well managed with topical treatments.

Participants will be observed over time to evaluate the progression of atopic dermatitis and related conditions. The study will also look at real-world treatment patterns, such as dosing and reasons for changing treatments, as well as the effectiveness and safety of these treatments. 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 currently receiving systemic treatment or are candidates for such treatment are eligible. Participants should not be involved in any other clinical trial that changes their care.
  • Study details: Participants will be observed to gather information on their condition and treatment patterns. No changes to their current treatment will be made as part of this study.
  • Study timelines: The study will last 120 months.

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