Treatment and Control of Atopic Dermatitis With 0.1% Tacrolimus Ointment
NCT ID: NCT00480610
Last Updated: 2014-09-18
Study Results
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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COMPLETED
PHASE3
226 participants
INTERVENTIONAL
2004-04-30
2005-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
tacrolimus ointment
Topical application
2
Placebo ointment
Topical application
Interventions
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tacrolimus ointment
Topical application
Placebo ointment
Topical application
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 clinically significant skin infection on the affected (and to be treated) area
16 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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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
Brussels, , Belgium
Edegem, , Belgium
Prague, , Czechia
Aarjus, , Denmark
Helsinki, , Finland
Paris, , France
Saint-Etienne, , France
Bonn, , Germany
Dresden, , Germany
Düsseldorf, , Germany
München, , Germany
Modena, , Italy
Roma, , Italy
Amsterdam, , Netherlands
Utrecht, , Netherlands
Almada, , Portugal
Barcelona, , Spain
Madrid, , Spain
Geneva, , Switzerland
Cardiff, , United Kingdom
Southhampton, , United Kingdom
Countries
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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.
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.
Other Identifiers
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FG-506-06-40
Identifier Type: -
Identifier Source: org_study_id
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