Atopic dermatitis
Conditions
Interventions
Trade Name: Neoral
Product Name: Cyclosporine A
Product Code: SUB129839
Pharmaceutical Form: Capsule
INN or Proposed INN: Cyclosporine A
Other descriptive name: CICLOSPORIN A
Concentration unit: mg mi
Sponsors
Erasmus MC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The current study has two main objectives; - to investigate if NMF biomarker status, corresponding with filaggrin genotype (FLG), has an effect on the effectiveness of systemic treatment with CsA in moderate-to-severe AD. - to investigate whether stratification of children with AD on the NMF biomarker results in an improvement of efficiency in the use of systemic treatment with CsA of moderate-to- severe AD.;Secondary Objective: - To investigate if NMF biomarker status correlates with the presence of atopic comorbidities, such as allergic sensitization, rhino conjunctivitis, food allergy and asthma - To investigate if NMF biomarker status correlates with mental health status and the presence of psychosocial factors in the patient and/or family ;Primary end point(s): - Relative reduction in EASI (Eczema Area and Severity Index, EASI) at t = 6 months - Proportion of patients that achieved EASI75 (relative reduction of 75% from baseline EASI) without the use of rescue medication, at t = 6 months;Timepoint(s) of evaluation of this end point: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Relative and absolute reduction in EASI from baseline at t = 1, 2, 3, 6, 9 and 12 months - Relative and absolute reduction in SCORAD (Scoring Atopic Dermatitis) from baseline at t = 1, 2, 3, 6, 9 and 12 months - Proportion of patients that achieved IGA 0 or IGA 1 (Investigator’s Global Assessment) without the use of rescue medication at t = 3, 6, 9 and 12 months - Absolute reduction and proportion of patients that achieved a reduction =4 points on the NRS-11 for itch intensity (Numeric Rating Scale) at t = 3, 6, 9 and 12 months - Relative and absolute reduction in POEM (Patient-Oriented Eczema Measure) from baseline at t = 1, 2, 3, 6, 9 and 12 months - Emollients and steroid use in frequency and tubes used (per patient) over the course of 12 months - Quality of life by patients (CDLQI 4-18 years (Children’s Dermatology Life Quality Index); <4 years IDQOL (Infants’ Dermatitis Quality of Life Index)) and by parents (EQ-5D-Y (Parents’ Dermatitis Family Impact Questionnaire)) at t = 0, 6 and 12 months - Healthcare costs related to the treatment of AD (medical specialist care, hospitalization, and costs directly associated with complications and recurrence) over the course of 12 months;Timepoint(s) of evaluation of this end point: - EASI at t = 1, 2, 3, 6, 9 and 12 months - SCORAD at t = 1, 2, 3, 6, 9 and 12 months - IGA at t = 3, 6, 9 and 12 months - NRS-11 for itch intensity at t = 3, 6, 9 and 12 months - POEM at t = 1, 2, 3, 6, 9 and 12 months - Emollients and steroid use in frequency and tubes used (per patient) over the course of 12 months - CDLQI/IDQOL and EQ-5D-Y at t = 0, 6 and 12 months - Healthcare costs at 12 months | — |
Countries
Netherlands
Contacts
Public ContactDepartment of dermatology
Erasmus MC
Outcome results
None listed