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

Observational Study on Treatment Patterns in Atopic Dermatitis for Children

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.

Updated on 15 Jun 2025. Study ID: NCT06415175

This study investigates the treatment patterns of children with Atopic Dermatitis (AD) aged 6 months to 11 years in Spain. Atopic Dermatitis is a skin condition that causes dry, itchy, and inflamed skin. The purpose of this study is to understand the characteristics of these patients, their disease, and the treatments they have received in the past. It also looks at how well an investigational medication works and how safe it is over two years, but does not involve any treatment outside of what is normally done in clinics.

In this study, participants will have their treatment patterns and disease characteristics documented. There will be no additional diagnostic or therapeutic procedures beyond regular clinical practice. The safety and effectiveness of the investigational medication will be observed as part of routine care.

  • Who can participate: Children aged 6 months to 11 years with severe Atopic Dermatitis can participate. They must be starting dupilumab and have consent from their guardians.
  • Study details: Participants will continue their usual care without any extra procedures. The study will observe the effects of dupilumab, which is part of their regular treatment plan.
  • Study timelines: The study will last two years.

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