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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00673725
Recruitment Status : Completed
First Posted : May 7, 2008
Last Update Posted : August 25, 2014
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe B.V. )

Brief Summary:
To assess the efficacy of Locobase REPAIR® when used in children with moderate to severe AD

Condition or disease Intervention/treatment Phase
Dermatitis, Atopic Drug: Locobase® REPAIR Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2008
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: 1 Drug: Locobase® REPAIR

Primary Outcome Measures :
  1. Change in mEASI from baseline to week 3 [ Time Frame: 3 Weeks ]

Secondary Outcome Measures :
  1. Physicians Global Evaluation of Clinical Response [ Time Frame: 6 Weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Months to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00673725

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United Kingdom
Liverpool, United Kingdom
Manchester, United Kingdom
Reading, United Kingdom
Sponsors and Collaborators
Astellas Pharma Europe B.V.
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Study Chair: Use Central Contact Astellas Pharma Europe B.V.

Additional Information:
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Responsible Party: Astellas Pharma Europe B.V. Identifier: NCT00673725    
Other Study ID Numbers: REP-EC-001
EudraCT #: 2006-006462-42
First Posted: May 7, 2008    Key Record Dates
Last Update Posted: August 25, 2014
Last Verified: August 2014
Keywords provided by Astellas Pharma Inc ( Astellas Pharma Europe B.V. ):
Atopic Dermatitis
Additional relevant MeSH terms:
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Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases