Study in Paediatric Patients With Atopic Dermatitis Treated With Dupilumab in Spain

Study on Treatment Patterns in Children with Atopic Dermatitis

Recruiting
6 months - 11 years
All
Phase N/A
150 participants needed
15 Locations

Study Overview

This is a multicentre, prospective, non-interventional study that aims to describe the treatment patterns of in Atopic dermatitis (AD) patients aged 6 months to 11 years old in Spain: patients' characteristics, disease characteristics, prior treatments for and treatment prescription modalities. As well as to document the real-world effectiveness and safety of dupilumab during the two years of follow up. No diagnostic or therapeutic intervention outside of routine clinical practice will be applied.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Atopic Dermatitis
  • Age: 6 months - 11 years
  • Gender: All

Inclusion Criteria:

  • Male or female aged 6 months to 11 years old at baseline.
  • Patients with severe Atopic dermatitis (AD) according to the investigator's assessment.
  • Patients initiating dupilumab (in those patients initiated retrospectively 2 months before the start of the study, the baseline information must be correctly filled out in the medical records).
  • Signed informed consent by the parent/legally acceptable representative and assent by the patient appropriate to the patient's age.

Exclusion Criteria:

  • Patients who are participating in an interventional clinical trial that modifies patient care.

This study investigates the treatment patterns in children aged 6 months to 11 years with atopic dermatitis in Spain. This study will look at how these children are treated, their disease characteristics, and any previous treatments they have received. The purpose is to understand the real-world effectiveness and safety of an investigational medication over a two-year period.

Participants will be observed as they receive routine care for their atopic dermatitis. No additional diagnostic or therapeutic interventions will be applied beyond what is considered normal clinical practice. This means that the study will document the outcomes of the treatment without altering the usual care that patients receive.

  • Who can participate: Children aged 6 months to 11 years with severe atopic dermatitis can participate. They must be starting treatment with the investigational medication, and proper consent must be obtained from their guardians.
  • Study details: Participants will be observed while receiving routine care for atopic dermatitis. This means their treatment will not be changed for the study, and no additional procedures will be performed.
  • Study timelines: The study will last two years.
Updated on 25 Sep 2025. Study ID: NCT06415175

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