NCT00535691

Brief Summary

The purpose of this study is to estimate the systemic exposure to tacrolimus in infants with atopic dermatitis after repeated application of tacrolimus ointment. Efficacy of tacrolimus ointment, evaluated by examination of treated areas, will also be measured.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2003

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

April 1, 2003

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 26, 2007

Completed
Last Updated

September 1, 2014

Status Verified

August 1, 2014

First QC Date

September 21, 2007

Last Update Submit

August 28, 2014

Conditions

Dermatitis, Atopic

Outcome Measures

Primary Outcomes (1)

  • Estimate the systemic exposure to tacrolimus after first and repeated application of 0.03% tacrolimus ointment in paediatric patients with atopic dermatitis stratified by application area and randomised to once a day (UID) or twice a day (BID) treatment.

    Day 1 and 14

Secondary Outcomes (1)

  • Efficacy of tacrolimus ointment, evaluated by examination of treated areas.

    Day 4, 14 and 18

Study Arms (2)

1

ACTIVE COMPARATOR

Tacrolimus ointment 0.03% once daily, placebo once daily

Drug: Tacrolimus Ointment 0.03%

2

ACTIVE COMPARATOR

Tacrolimus ointment 0.03% twice daily

Drug: Tacrolimus Ointment 0.03%

Interventions

Tacrolimus Ointment 0.03%DRUG

Twice daily, 14 days treatment.

Also known as: Protopic 0.03%
2

Eligibility Criteria

Age3 Months - 24 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patient is between 3 and 24 months old on Day 1.
  • The patient has atopic dermatitis requiring treatment with mid potent topical steroids.
  • Patient's disease involves a percentage area to be treated greater than or equal to 5% of the total body surface area

You may not qualify if:

  • Patient has clinically infected atopic dermatitis.
  • Patient has a history of more than two courses of systemic corticosteroid treatment

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 GmbH

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2007

First Posted

September 26, 2007

Study Start

April 1, 2003

Study Completion

December 1, 2004

Last Updated

September 1, 2014

Record last verified: 2014-08

Locations

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