se of the NMF biomarker as predictive diagnostic for effective use of cyclosporine in the treatment of atopic dermatitis. - NMF-CsA trial

Erasmus MC0 个研究点目标入组 152 人开始时间: 2019年10月15日最近更新: 2020年7月6日

适应症

试验速览

暂无简介。

•- children and adolescents, aged between 2 and 18, 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 = 6 at screening and baseline (corresponding with moderate-to-severe disease)
•- IGA of 3 or higher at screening and baseline (corresponding with moderate-to-severe disease)
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 152
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- children under the age of 2 years (due to the prescribe conditions of CsA)
•- contraindication for CsA
•- use of topical corticosteroids (TCS) or topical calcineurine inhibitors (TCI) 2 weeks before randomization
•- 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

发起方