A PHASE IV, OPEN LABEL, PILOT STUDY OF THE TREATMENT OF CHILDREN WITH MODERATE TO SEVERE ATOPIC DERMATITIS (AD) USING LOCOBASE REPAIR® AS AN ADJUNCTIVE TO STANDARD TREATMENT

Phase 1

• Conditions: Atopic dermatitis; MedDRA version: 9.1 Level: LLT Classification code 10003639 Term: Atopic dermatitis

• Registration Number: EUCTR2006-006462-42-GB
• Lead Sponsor: Astellas Pharma Europe B.V

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-06-03
• Study Completion: 2008-09-16
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 49

Inclusion Criteria

1.Has given written informed consent (parents or guardian, child if applicable)
2.At least 18 months and less than 16 years old at study entry
3.Moderate to severe AD
4.Continuous use of topical corticosteroid or topical calcineurin inhibitor (TCI) as active treatment of AD for more than 4 weeks prior to day 1
5.In the opinion of the investigator, subjects are unlikely to require a significant change to their current treatment regimen during the study period

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Has infected lesions
2.The last assessment of any clinical study within 3 months prior to the expected date of entering into the study
3.Subject is currently using systemic corticosteroids
4.Current use of Locobase REPAIR®
5.Known allergy to Locobase REPAIR® or any of its components
6.Any clinical condition which, in the opinion of the investigator, would not allow safe completion of the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): Change in mEASI from baseline to week 3;Main Objective: To assess the efficacy of Locobase REPAIR® when used in children with moderate to severe AD;<br> Secondary Objective: •To measure subject assessment of Locobase REPAIR® efficacy<br> •To assess health economics and patient reported outcomes<br>