- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00673725
Locobase® REPAIR Used as an Adjunctive to Standard Therapy in Children With Moderate to Severe Atopic Dermatitis
August 22, 2014 updated by: Astellas Pharma Europe B.V.
A Phase IV,Open Label Study of the Treatment of Children With Moderate to Severe Atopic Dermatitis (AD) Using Locobase® REPAIR as an Adjunctive to Standard Treatment
To assess the efficacy of Locobase REPAIR® when used in children with moderate to severe AD
Study Overview
Study Type
Interventional
Enrollment (Actual)
49
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Liverpool, United Kingdom
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Manchester, United Kingdom
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Reading, United Kingdom
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 16 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
emollient
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in mEASI from baseline to week 3
Time Frame: 3 Weeks
|
3 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Physicians Global Evaluation of Clinical Response
Time Frame: 6 Weeks
|
6 Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2008
Primary Completion (Actual)
September 1, 2008
Study Completion (Actual)
September 1, 2008
Study Registration Dates
First Submitted
May 6, 2008
First Submitted That Met QC Criteria
May 6, 2008
First Posted (Estimate)
May 7, 2008
Study Record Updates
Last Update Posted (Estimate)
August 25, 2014
Last Update Submitted That Met QC Criteria
August 22, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REP-EC-001
- EudraCT #: 2006-006462-42
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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