Efficacy and Safety of Different Concentrations of Mapracorat Ointment Over 4 Weeks in Atopic Dermatitis (AD)
NCT ID: NCT01359787
Last Updated: 2015-01-21
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
PHASE2
197 participants
INTERVENTIONAL
2011-05-31
2011-09-30
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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Mapracorat 0.01% Ointment
Lowest concentration
Mapracorat
Daily topical application
Mapracorat 0.03% Ointment
Middle concentration
Mapracorat
Daily topical application
Mapracorat 0.1% Ointment
Highest concentration
Mapracorat
Daily topical application
Vehicle without active
Vehicle without active
Daily topical application
Interventions
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Mapracorat
Daily topical application
Vehicle without active
Daily topical application
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of atopic dermatitis according to Hanifin and Rajka Criteria
* Willingness of subject to follow all study procedures
* Willingness to avoid excessive exposure of diseased areas to natural or artificial sunlight
Exclusion Criteria
* Clinically relevant disease, which could interfere with the study conduct or the evaluation and interpretation of the study results
* Clinically manifested immunosuppressive disorder or known history of malignant disease
* History of relevant drug and/or food allergies
18 Years
65 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Berlin, , Germany
Countries
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Other Identifiers
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1403440
Identifier Type: OTHER
Identifier Source: secondary_id
2010-024279-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
15616
Identifier Type: -
Identifier Source: org_study_id
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