NCT00673725

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2008

Shorter than P25 for phase_4

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 7, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

August 25, 2014

Status Verified

August 1, 2014

Enrollment Period

6 months

First QC Date

May 6, 2008

Last Update Submit

August 22, 2014

Conditions

Dermatitis, Atopic

Keywords

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

  • Change in mEASI from baseline to week 3

    3 Weeks

Secondary Outcomes (1)

  • Physicians Global Evaluation of Clinical Response

    6 Weeks

Study Arms (1)

1

EXPERIMENTAL
Drug: Locobase® REPAIR

Interventions

Locobase® REPAIRDRUG

emollient

1

Eligibility Criteria

Age18 Months - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Liverpool, United Kingdom

Location

Unknown Facility

Manchester, United Kingdom

Location

Unknown Facility

Reading, United Kingdom

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Use Central Contact

    Astellas Pharma Europe B.V.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2008

First Posted

May 7, 2008

Study Start

March 1, 2008

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

August 25, 2014

Record last verified: 2014-08

Locations

GB(3)