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

Primary Purpose

Dermatitis, Atopic

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Locobase® REPAIR
Sponsored by
Astellas Pharma Europe B.V.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dermatitis, Atopic focused on measuring Atopic Dermatitis

Eligibility Criteria

18 Months - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Change in mEASI from baseline to week 3

Secondary Outcome Measures

Physicians Global Evaluation of Clinical Response

Full Information

First Posted
May 6, 2008
Last Updated
August 22, 2014
Sponsor
Astellas Pharma Europe B.V.
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1. Study Identification

Unique Protocol Identification Number
NCT00673725
Brief Title
Locobase® REPAIR Used as an Adjunctive to Standard Therapy in Children With Moderate to Severe Atopic Dermatitis
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 Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Europe B.V.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Atopic
Keywords
Atopic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Locobase® REPAIR
Intervention Description
emollient
Primary Outcome Measure Information:
Title
Change in mEASI from baseline to week 3
Time Frame
3 Weeks
Secondary Outcome Measure Information:
Title
Physicians Global Evaluation of Clinical Response
Time Frame
6 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Organizational Affiliation
Astellas Pharma Europe B.V.
Official's Role
Study Chair
Facility Information:
City
Liverpool
Country
United Kingdom
City
Manchester
Country
United Kingdom
City
Reading
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://www.clinicaltrials.jp/user/ctrSearch_e.jsp
Description
Link to Results on JAPIC - enter 140546 in the JapicCTI-RNo. field

Learn more about this trial

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

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