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Efficacy and Safety of Different Concentrations of Mapracorat Ointment Over 4 Weeks in Atopic Dermatitis (AD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01359787
Recruitment Status : Completed
First Posted : May 25, 2011
Last Update Posted : January 21, 2015
Information provided by (Responsible Party):

Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of three concentrations of a development drug compared to ointment base (vehicle) in subjects with Atopic Dermatitis (AD).

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Eczema Drug: Mapracorat Drug: Vehicle without active Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 197 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-blind, Randomized, Vehicle-controlled, Multicenter, Multinational, Parallel-group Study of the Efficacy and Safety of Mapracorat Ointment in Three Concentrations Over Max. 4 Weeks in Subjects With Atopic Dermatitis (AD)
Study Start Date : May 2011
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Active Comparator: Mapracorat 0.01% Ointment
Lowest concentration
Drug: Mapracorat
Daily topical application

Active Comparator: Mapracorat 0.03% Ointment
Middle concentration
Drug: Mapracorat
Daily topical application

Active Comparator: Mapracorat 0.1% Ointment
Highest concentration
Drug: Mapracorat
Daily topical application

Placebo Comparator: Vehicle without active Drug: Vehicle without active
Daily topical application

Primary Outcome Measures :
  1. Eczema Area and Severity Index (EASI) [ Time Frame: Over all study visits for up to 4 weeks ]

Secondary Outcome Measures :
  1. Subjects´ assessment of pruritus [ Time Frame: At baseline and after 4 weeks of treatment ]
    Subjects´ assessment of pruritus using a visual analog scale (VAS)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Signed written informed consent
  • 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:

  • Pregnancy and breast-feeding
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01359787

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Berlin, Germany, 10589
Sponsors and Collaborators
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Study Director: Bayer Study Director Bayer
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Responsible Party: Bayer Identifier: NCT01359787    
Other Study ID Numbers: 15616
1403440 ( Other Identifier: Company internal )
2010-024279-14 ( EudraCT Number )
First Posted: May 25, 2011    Key Record Dates
Last Update Posted: January 21, 2015
Last Verified: January 2015
Additional relevant MeSH terms:
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Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases