NCT00480896

Brief Summary

A long-term 0.03% tacrolimus ointment based regimen comprising of up to 6 weeks of initial twice daily treatment and subsequent twice weekly prophylactic application can effectively treat active lesions of atopic dermatitis, and prevent, delay, and reduce flares.

Trial Health

98
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jun 2004

Geographic Reach
11 countries

22 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, 2004

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 31, 2007

Completed
Last Updated

September 18, 2014

Status Verified

September 1, 2014

Enrollment Period

1.4 years

First QC Date

May 30, 2007

Last Update Submit

September 17, 2014

Conditions

Dermatitis, Atopic

Keywords

Dermatitis, atopicTacrolimusChildtreatment outcomes

Outcome Measures

Primary Outcomes (1)

  • Number of exacerbations of atopic dermatitis requiring intervention.

    12 months

Secondary Outcomes (1)

  • Time to first exacerbation requiring intervention; exacerbation treatment days, periods and time to first exacerbation; physician and patient assessment of affected area, treatment response; quality of life; global response.

    12 months

Study Arms (2)

1

EXPERIMENTAL
Drug: tacrolimus ointment

2

PLACEBO COMPARATOR
Drug: Placebo ointment

Interventions

tacrolimus ointmentDRUG

Topical application

Also known as: Protopic®, FK506 ointment
1
Placebo ointmentDRUG

Topical application

2

Eligibility Criteria

Age2 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Male or female patient of any ethnic group
  • Patient was at least 2-15 years old and suffered from mild to severe atopic dermatitis (Rajka/Langeland score of at least 3)

You may not qualify if:

  • Patient had a genetic epidermal barrier defect such as Netherton's syndrome or generalised erythroderma
  • Patient had a clinically significant skin infection on the affected (and to be treated) area

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Unknown Facility

Brussels, Belgium

Location

Unknown Facility

Brno, Czechia

Location

3 Sites

Prague, Czechia

Location

Unknown Facility

Helsinki, Finland

Location

Unknown Facility

Nantes, France

Location

Unknown Facility

Paris, France

Location

Unknown Facility

Düsseldorf, Germany

Location

Unknown Facility

Frankfurt, Germany

Location

Unknown Facility

Kiel, Germany

Location

Unknown Facility

Mahlow, Germany

Location

Unknown Facility

Budapest, Hungary

Location

Unknown Facility

Bergamo, Italy

Location

Unknown Facility

Parma, Italy

Location

Unknown Facility

Roma, Italy

Location

Unknown Facility

Amsterdam, Netherlands

Location

Unknown Facility

Groningen, Netherlands

Location

Unknown Facility

Nijmegen, Netherlands

Location

Unknown Facility

Utrecht, Netherlands

Location

Unknown Facility

Porto, Portugal

Location

Unknown Facility

Barcelona, Spain

Location

Unknown Facility

Birmingham, United Kingdom

Location

Unknown Facility

London, United Kingdom

Location

Related Publications (1)

  • Thaci D, Reitamo S, Gonzalez Ensenat MA, Moss C, Boccaletti V, Cainelli T, van der Valk P, Buckova H, Sebastian M, Schuttelaar ML, Ruzicka T; European Tacrolimus Ointment Study Group. Proactive disease management with 0.03% tacrolimus ointment for children with atopic dermatitis: results of a randomized, multicentre, comparative study. Br J Dermatol. 2008 Dec;159(6):1348-56. doi: 10.1111/j.1365-2133.2008.08813.x. Epub 2008 Sep 6.

    PMID: 18782319BACKGROUND

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Use Central Contact

    Universitätsklinikum Frankfurt Zentrum für Dermatologie

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2007

First Posted

May 31, 2007

Study Start

June 1, 2004

Primary Completion

November 1, 2005

Study Completion

November 1, 2005

Last Updated

September 18, 2014

Record last verified: 2014-09

Locations

NL(4)IT(3)GB(2)ES(1)BE(1)CZ(2)PT(1)FR(2)HU(1)FI(1)DE(4)