Treatment and Control of Atopic Dermatitis With 0.03% Tacrolimus Ointment

NCT ID: NCT00480896

Last Updated: 2014-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2005-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Dermatitis, Atopic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

tacrolimus ointment

Intervention Type DRUG

Topical application

2

Group Type PLACEBO_COMPARATOR

Placebo ointment

Intervention Type DRUG

Topical application

Interventions

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tacrolimus ointment

Topical application

Intervention Type DRUG

Placebo ointment

Topical application

Intervention Type DRUG

Other Intervention Names

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Protopic® FK506 ointment

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* 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
Minimum Eligible Age

2 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Use Central Contact

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Frankfurt Zentrum für Dermatologie

Locations

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Brussels, , Belgium

Site Status

Brno, , Czechia

Site Status

3 Sites

Prague, , Czechia

Site Status

Helsinki, , Finland

Site Status

Nantes, , France

Site Status

Paris, , France

Site Status

Düsseldorf, , Germany

Site Status

Frankfurt, , Germany

Site Status

Kiel, , Germany

Site Status

Mahlow, , Germany

Site Status

Budapest, , Hungary

Site Status

Bergamo, , Italy

Site Status

Parma, , Italy

Site Status

Roma, , Italy

Site Status

Amsterdam, , Netherlands

Site Status

Groningen, , Netherlands

Site Status

Nijmegen, , Netherlands

Site Status

Utrecht, , Netherlands

Site Status

Porto, , Portugal

Site Status

Barcelona, , Spain

Site Status

Birmingham, , United Kingdom

Site Status

London, , United Kingdom

Site Status

Countries

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Belgium Czechia Finland France Germany Hungary Italy Netherlands Portugal Spain United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 18782319 (View on PubMed)

Other Identifiers

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FG-506-06-41

Identifier Type: -

Identifier Source: org_study_id

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