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

Dermatitis, Atopic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00673725
• Other study ID #: REP-EC-001
• Secondary ID: EudraCT #: 2006-
• Status: Completed
• Phase: Phase 4
• First received: May 6, 2008
• Last updated: August 22, 2014
• Start date: March 2008
• Est. completion date: September 2008

Study information

• Verified date: August 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Months to 16 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Locobase® REPAIR
emollient

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Europe B.V.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mEASI from baseline to week 3		3 Weeks	No
Secondary	Physicians Global Evaluation of Clinical Response		6 Weeks	No

External Links

•   Link to Results on JAPIC - enter 140546 in the JapicCTI-RNo. field