Treatment and Control of Atopic Dermatitis With 0.03% Tacrolimus Ointment
NCT ID: NCT00480896
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
250 participants
INTERVENTIONAL
2004-06-30
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 2-15 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
2 Years
15 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
Universitätsklinikum Frankfurt Zentrum für Dermatologie
Locations
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Brussels, , Belgium
Brno, , Czechia
3 Sites
Prague, , Czechia
Helsinki, , Finland
Nantes, , France
Paris, , France
Düsseldorf, , Germany
Frankfurt, , Germany
Kiel, , Germany
Mahlow, , Germany
Budapest, , Hungary
Bergamo, , Italy
Parma, , Italy
Roma, , Italy
Amsterdam, , Netherlands
Groningen, , Netherlands
Nijmegen, , Netherlands
Utrecht, , Netherlands
Porto, , Portugal
Barcelona, , Spain
Birmingham, , United Kingdom
London, , United Kingdom
Countries
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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.
Other Identifiers
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FG-506-06-41
Identifier Type: -
Identifier Source: org_study_id
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