Treatment and Control of Atopic Dermatitis With 0.1% Tacrolimus Ointment

NCT ID: NCT00480610

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

226 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2005-11-30

Brief Summary

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Long-term 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 \& 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®

Eligibility Criteria

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Inclusion Criteria

* Male or female patient of any ethnic group
* Patient was at least 16 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

16 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

Klinik und Poliklinik für Dermatologie und Allergologie, Ludwig-Maximilians Universität

Locations

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Innsbruck, , Austria

Site Status

Brussels, , Belgium

Site Status

Edegem, , Belgium

Site Status

Prague, , Czechia

Site Status

Aarjus, , Denmark

Site Status

Helsinki, , Finland

Site Status

Paris, , France

Site Status

Saint-Etienne, , France

Site Status

Bonn, , Germany

Site Status

Dresden, , Germany

Site Status

Düsseldorf, , Germany

Site Status

München, , Germany

Site Status

Modena, , Italy

Site Status

Roma, , Italy

Site Status

Amsterdam, , Netherlands

Site Status

Utrecht, , Netherlands

Site Status

Almada, , Portugal

Site Status

Barcelona, , Spain

Site Status

Madrid, , Spain

Site Status

Geneva, , Switzerland

Site Status

Cardiff, , United Kingdom

Site Status

Southhampton, , United Kingdom

Site Status

Countries

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Austria Belgium Czechia Denmark Finland France Germany Italy Netherlands Portugal Spain Switzerland United Kingdom

References

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Wollenberg A, Reitamo S, Girolomoni G, Lahfa M, Ruzicka T, Healy E, Giannetti A, Bieber T, Vyas J, Deleuran M; European Tacrolimus Ointment Study Group. Proactive treatment of atopic dermatitis in adults with 0.1% tacrolimus ointment. Allergy. 2008 Jul;63(7):742-50.

Reference Type BACKGROUND
PMID: 18592619 (View on PubMed)

Wollenberg A, Sidhu MK, Odeyemi I, Dorsch B, Koehne-Volland R, Schaff M, Ehlken B, Berger K. Economic evaluation of maintenance treatment with tacrolimus 0.1% ointment in adults with moderate to severe atopic dermatitis. Br J Dermatol. 2008 Dec;159(6):1322-30. doi: 10.1111/j.1365-2133.2008.08807.x. Epub 2008 Sep 6.

Reference Type BACKGROUND
PMID: 18782316 (View on PubMed)

Other Identifiers

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FG-506-06-40

Identifier Type: -

Identifier Source: org_study_id

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