se of the NMF Biomarker as Predictive Diagnostic for Effective Use of Cyclosporine and Dupilumab in the Treatment of Atopic Dermatitis

Conditions: Atopic dermatitis

Registration Number: NL-OMON23450

Lead Sponsor: Erasmus MC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 318

Inclusion Criteria

Children and adolescents, aged between 2 and 18, with moderate to severe atopic dermatitis (diagnosed according to the UK working party criteria)
-Patients 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 (Investigators Global Assessment) = 3 at screening and baseline (corresponding with moderate-to-severe disease)

Exclusion Criteria

-children under the age of 2 years (due to the prescribe conditions of CsA) and patients older than 18 years
-contraindication for CsA or dupilumab
-use of topical corticosteroids (TCS) or topical calcineurine inhibitors (TCI) 2 weeks before randomization (during the washout period)
-use of systemic anti-inflammatory medication 4 weeks before randomization
-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 at baseline
-IGA <3 at screening or at baseline

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
-Relative reduction in EASI (Eczema Area and Severity Index, EASI) at t = 6 months<br>-Proportion of patients that achieved EASI75 (relative reduction of 75% from baseline EASI) without the use of rescue medication, at t = 6 months<br>

Secondary Outcome Measures