NCT00560326

Brief Summary

The objective of this study is to assess the safety and efficacy of 0.03% tacrolimus ointment as long-term treatment in paediatric patients with atopic dermatitis.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2003

Typical duration for phase_2

Geographic Reach
5 countries

8 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

June 1, 2003

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 19, 2007

Completed
Last Updated

September 1, 2014

Status Verified

August 1, 2014

First QC Date

November 16, 2007

Last Update Submit

August 28, 2014

Conditions

Dermatitis, Atopic

Keywords

Paediatric patientsTacrolimusDermatitis, Atopic

Outcome Measures

Primary Outcomes (1)

  • Assess safety from observations of adverse events, laboratory examinations, pulse, height, weight and tacrolimus blood concentrations

    24 months

Secondary Outcomes (1)

  • Assess efficacy from parameters as follows: - Physician's global evaluation of clinical response - Physician's assessment of individual signs - Affected area - Parent/guardian's assessment of global response - EASI

    24 months

Study Arms (1)

1

EXPERIMENTAL
Drug: Tacrolimus Ointment 0.03%

Interventions

Tacrolimus Ointment 0.03%DRUG

Once or twice daily topical application

Also known as: Protopic 0.03%
1

Eligibility Criteria

Age6 Months - 30 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patient has participated in the study FG-506-06-32, has applied at least one dose of study medication and has benefited from treatment in the opinion of the investigator.
  • Patient is likely to benefit from further treatment with tacrolimus ointment in the opinion of the investigator.

You may not qualify if:

  • Patient has a skin disorder on the affected (and to be treated) area, other than atopic dermatitis, requiring treatment.
  • Patient has clinically infected atopic dermatitis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Unknown Facility

Halifax, Canada

Location

Unknown Facility

Vancouver, Canada

Location

Unknown Facility

Waterloo, Canada

Location

Unknown Facility

Helsinki, Finland

Location

Unknown Facility

Drogheda, Ireland

Location

Unknown Facility

Dublin, Ireland

Location

Unknown Facility

Riga, Latvia

Location

Unknown Facility

London, 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

  • Central Contact

    Astellas Pharma Europe B.V.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2007

First Posted

November 19, 2007

Study Start

June 1, 2003

Study Completion

December 1, 2006

Last Updated

September 1, 2014

Record last verified: 2014-08

Locations

GB(1)IE(2)FI(1)CA(3)LA(1)