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

NCT ID: NCT00673725

Last Updated: 2014-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2008-09-30

Brief Summary

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

Detailed Description

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Conditions

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Dermatitis, Atopic

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Locobase® REPAIR

Intervention Type DRUG

emollient

Interventions

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Locobase® REPAIR

emollient

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Months

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Europe B.V.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Use Central Contact

Role: STUDY_CHAIR

Astellas Pharma Europe B.V.

Locations

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Liverpool, , United Kingdom

Site Status

Manchester, , United Kingdom

Site Status

Reading, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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EudraCT #: 2006-006462-42

Identifier Type: -

Identifier Source: secondary_id

REP-EC-001

Identifier Type: -

Identifier Source: org_study_id

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