Observational Evaluation of Atopic Dermatitis in Pediatric Patients (PEDISTAD)

Study of Atopic Dermatitis in Children

Recruiting
11 years or below
All
Fase N/A
1845 participants needed
2 Locations

Brief description of study

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.

Detailed description of study

The study duration is 120 months.

Eligibility of study

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 15 Apr 2025. Study ID: NCT03687359

This study investigates atopic dermatitis (AD) in children with moderate to severe symptoms. Atopic dermatitis is a chronic skin condition characterized by itchy and inflamed skin, often associated with other allergic conditions such as asthma and hay fever. The purpose of this study is to observe and describe the characteristics of pediatric patients whose AD is not well managed with topical treatments or for whom such treatments are not suitable.

The study involves observing the progression of AD and related conditions over time, as well as documenting the real-world effectiveness and safety of various treatments. Participants will not have any changes made to their current treatment plans, as this is an observational study. 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 on systemic treatment or eligible for it can participate. Participants should not be part of another clinical trial that alters their treatment.
  • Study details: Participants will continue their current treatments while researchers observe and document their condition and treatment outcomes.
  • Study Timelines: The study will last 120 months.

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