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

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00673725
First received: May 6, 2008
Last updated: October 20, 2008
Last verified: October 2008
  Purpose

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


Condition Intervention Phase
Dermatitis, Atopic
Drug: Locobase® REPAIR
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Change in mEASI from baseline to week 3 [ Time Frame: 3 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Physicians Global Evaluation of Clinical Response [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]

Enrollment: 49
Study Start Date: March 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Locobase® REPAIR
emollient

  Eligibility

Ages Eligible for Study:   18 Months to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00673725

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

No publications provided

Responsible Party: Disclosure Office Europe, Astellas Pharma Europe BV
ClinicalTrials.gov Identifier: NCT00673725     History of Changes
Other Study ID Numbers: REP-EC-001, EudraCT #: 2006-006462-42
Study First Received: May 6, 2008
Last Updated: October 20, 2008
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Astellas Pharma Inc:
Atopic Dermatitis

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 20, 2014