NMF-CsA-Dupi Trial
- Conditions
- Dermatitis, Atopic
- Interventions
- Registration Number
- NCT04878770
- Lead Sponsor
- Erasmus Medical Center
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 318
- 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)
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Systemic cyclosporine Topical corticosteroids This group will receive topical corticosteroids and systemic cyclosporin. Systemic dupilumab Systemic dupilumab his group will receive topical corticosteroids and systemic dupilumab. Topical corticosteroids (control) Topical corticosteroids This group will receive topical corticosteroids. Systemic cyclosporine Systemic cyclosporine This group will receive topical corticosteroids and systemic cyclosporin. Systemic dupilumab Topical corticosteroids his group will receive topical corticosteroids and systemic dupilumab.
- Primary Outcome Measures
Name Time Method EASI t = 0, 1 month, 2 months, 3 months and 6 months Change from baseline Eczema Area and Severity Index (0-72) over the course of 6 months, with higher scores meaning worse outcomes.
- Secondary Outcome Measures
Name Time Method IGA 0 or IGA 1 t = 0, 1 month, 2 months, 3 months and 6 months Proportion of patients that achieved IGA 0 or IGA 1 (Investigator's Global Assessment) without the use of rescue medication.
POEM t = 0, 1 month, 2 months, 3 months and 6 months Change from baseline in Patient-Oriented Eczema Measure questionnaire (0-28) over the course of 6 months, with higher scores meaning worse outcomes.
NRS-11 reduction for itch ≥ 4 points t = 0, 1 month, 2 months, 3 months and 6 months Proportion of patients that achieved a reduction ≥4 points on the Numeric Rating Scale-11 (0-10) for itch intensity.
EASI75 t = 1 month, 2 months, 3 months and 6 months Relative reduction of 75% from baseline EASI without the use of rescue medication
SCORAD t = 0, 1 month, 2 months, 3 months and 6 months Change from baseline in Scoring Atopic Dermatitis scale (0-103) over the course of 6 months, with higher scores meaning worse outcomes.
RECAP t = 0, 1 month, 2 months, 3 months and 6 months Change from baseline in the Recap of Atopic Eczema questionnaire (0-28) over the course of 6 months, with higher scores meaning worse outcomes.
Trial Locations
- Locations (1)
Erasmus MC - Sophia Children's Hospital
🇳🇱Rotterdam, Zuid-Holland, Netherlands