Dermatitis, Atopic
Conditions
Keywords
Atopic Dermatitis
Brief summary
To assess the efficacy of Locobase REPAIR® when used in children with moderate to severe AD
Interventions
DRUGLocobase® REPAIR
emollient
Sponsors
Astellas Pharma Europe B.V.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Months to 16 Years
Healthy volunteers
No
Inclusion criteria
* Has given written informed consent (parents or guardian, child if applicable) * Moderate to severe AD * Continuous use of topical corticosteroid or topical calcineurin inhibitor (TCI) as active treatment of AD for more than 4 weeks prior to screening (no change in topical corticosteroid or TCI is allowed between screening and day 1) * In the opinion of the investigator, subject is unlikely to require a significant change to his/her current treatment regimen during the study period
Exclusion criteria
* Has infected lesions * The last assessment of any clinical study within 3 months prior to the expected date of entering into the study * Current use of Locobase® REPAIR * Known allergy to Locobase® REPAIR or any of its components * Any clinical condition which, in the opinion of the investigator, would not allow safe completion of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in mEASI from baseline to week 3 | 3 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| Physicians Global Evaluation of Clinical Response | 6 Weeks |
Countries
United Kingdom
Outcome results
None listed