Atopic dermatitis MedDRA version: 9.1 Level: LLT Classification code 10003639 Term: Atopic dermatitis
Conditions
Interventions
Product Name: Locobase REPAIR
Pharmaceutical Form: Cream
Sponsors
Astellas Pharma Europe B.V
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Has given written informed consent (parents or guardian, child if applicable) 2. At least 18 months and less than 16 years old at study entry 3. Moderate to severe AD 4. Continuous use of topical corticosteroid or topical calcineurin inhibitor (TCI) as active treatment of AD for more than 4 weeks prior to day 1 5. In the opinion of the investigator, subjects are unlikely to require a significant change to their current treatment regimen during the study period Are the trial subjects under 18? yes Number of subjects for this age range: 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: 1. Has infected lesions 2. The last assessment of any clinical study within 3 months prior to the expected date of entering into the study 3. Subject is currently using systemic corticosteroids 4. Current use of Locobase REPAIR® 5. Known allergy to Locobase REPAIR® or any of its components 6. Any clinical condition which, in the opinion of the investigator, would not allow safe completion of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Change in mEASI from baseline to week 3;Main Objective: To assess the efficacy of Locobase REPAIR® when used in children with moderate to severe AD; Secondary Objective: • To measure subject assessment of Locobase REPAIR® efficacy • To assess health economics and patient reported outcomes | — |
Countries
United Kingdom
Outcome results
None listed