Overview

Locobase® REPAIR Used as an Adjunctive to Standard Therapy in Children With Moderate to Severe Atopic Dermatitis

Status:
Completed
Trial end date:
2008-09-01
Target enrollment:
0
Participant gender:
All
Summary
To assess the efficacy of Locobase REPAIR® when used in children with moderate to severe AD
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Astellas Pharma Europe B.V.
Criteria
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