Efficacy and Safety of Different Concentrations of Mapracorat Ointment Over 4 Weeks in Atopic Dermatitis (AD)
Phase 2
Completed
- Conditions
- Atopic DermatitisEczema
- Interventions
- Drug: Vehicle without active
- Registration Number
- NCT01359787
- Lead Sponsor
- Bayer
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 197
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vehicle without active Vehicle without active - Mapracorat 0.1% Ointment Mapracorat Highest concentration Mapracorat 0.03% Ointment Mapracorat Middle concentration Mapracorat 0.01% Ointment Mapracorat Lowest concentration
- Primary Outcome Measures
Name Time Method Eczema Area and Severity Index (EASI) Over all study visits for up to 4 weeks
- Secondary Outcome Measures
Name Time Method Subjects´ assessment of pruritus At baseline and after 4 weeks of treatment Subjects´ assessment of pruritus using a visual analog scale (VAS)