Locobase® REPAIR Used as an Adjunctive to Standard Therapy in Children With Moderate to Severe Atopic Dermatitis
Phase 4
Completed
- Conditions
- Dermatitis, Atopic
- Interventions
- Drug: Locobase® REPAIR
- Registration Number
- NCT00673725
- Lead Sponsor
- Astellas Pharma Europe B.V.
- Brief Summary
To assess the efficacy of Locobase REPAIR® when used in children with moderate to severe AD
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 49
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Locobase® REPAIR -
- Primary Outcome Measures
Name Time Method Change in mEASI from baseline to week 3 3 Weeks
- Secondary Outcome Measures
Name Time Method Physicians Global Evaluation of Clinical Response 6 Weeks