Trial Condition(s):
Atopic dermatitis, Eczema
Efficacy and Safety of Different Concentrations of Mapracorat Ointment Over 4 Weeks in Atopic Dermatitis (AD)
Bayer Identifier:
15616
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
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).
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Intendis GmbH Berlin, Germany, 10589 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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)
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
4
Primary Outcome
- Eczema Area and Severity Index (EASI)Timeframe: Over all study visits for up to 4 weeks
Secondary Outcome
- Subjects´ assessment of pruritusSubjects´ assessment of pruritus using a visual analog scale (VAS)Timeframe: At baseline and after 4 weeks of treatment
Additional Information
Copyright © Bayer
Powered by
