NL-OMON23450尚未招募不适用
se of the NMF Biomarker as Predictive Diagnostic for Effective Use of Cyclosporine and Dupilumab in the Treatment of Atopic Dermatitis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Erasmus MC
- 入组人数
- 318
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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)
排除标准
- •-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
研究者
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