MF biomarker as predictive diagnostic for effective use of ciclosporine in atopic dermatitis.

Phase 1

• Conditions: Atopic dermatitis; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2019-003247-30-NL
• Lead Sponsor: Erasmus MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-15
• Last Update Posted: 6 July 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 152

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified