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NMF-CsA-Dupi Trial

Recruiting
2 - 18 years of age
Both
Phase N/A

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Overview

The goal of this study is to investigate whether stratification of children with atopic dermatitis on the NMF biomarkers results in an improvement of effectiveness and efficiency in the use of systemic treatment (ciclosporin and dupilumab) in moderate-to-severe atopic dermatitis.

Eligibility

Inclusion Criteria:

  • Children and adolescents, aged 2-18 years, with moderate-to-severe atopic dermatitis (diagnosed according to the UK working party criteria)
  • Patient and parents/guardians able to participate in the study and willing to give written informed consent
  • EASI (Eczema Area Severity Index) ≥ 6 at screening and baseline (corresponding with moderate-to-severe disease)
  • IGA (Investigator Global Assessment) ≥ 3 at screening and baseline (corresponding with moderate-to-severe disease)

Exclusion Criteria:

  • Children under the age of 2 years and patients older than 18 years
  • Contraindication for ciclosporin
  • Contraindication for dupilumab
  • Patient (or one of the parents/guardians) not willing to be randomized
  • Children with a history of any known primary immunodeficiency disorder
  • Children with a history of cancer
  • EASI < 6 at screening or baseline
  • IGA < 3 at screening or baseline

Study details

Dermatitis, Atopic

NCT04878770

Erasmus Medical Center

25 January 2024

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