se of the NMF biomarker as predictive diagnostic for effective use of cyclosporine and dupilumab in the treatment of atopic dermatitis.

Recruiting

• Conditions: Atopic dermatitis; atopic eczema; eczema; 10014982

• Registration Number: NL-OMON54541
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 186

Inclusion Criteria

children and adolescents, aged between 2 - 18 years, with moderate to severe
atopic dermatitis
(AD 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
(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 - 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 at baseline -
IGA - Pregnancy

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- EASI (Eczema Area and Severity Index, EASI) at t = 1, 3 and 6 months</p><br>