NMF-CsA-Dupi Trial

  • End date
    Jan 1, 2025
  • participants needed
  • sponsor
    Erasmus Medical Center
Updated on 26 August 2021
topical corticosteroid
topical agents
high potency


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.

Condition Dermatite Atopique, Dermatitis, Atopic, Eczema (Atopic Dermatitis), Eczéma (Dermatite Atopique), ATOPIC DERMATITIS, Atopic Dermatitis
Treatment Topical corticosteroids, Systemic cyclosporine, Systemic dupilumab
Clinical Study IdentifierNCT04878770
SponsorErasmus Medical Center
Last Modified on26 August 2021


Yes No Not Sure

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
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