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)

Bayer0 sites197 target enrollmentMay 2011

ConditionsAtopic Dermatitis Eczema

InterventionsMapracorat Vehicle without active

DrugsMapracorat Vehicle without active

Overview

Phase: Phase 2
Intervention: Mapracorat
Conditions: Atopic Dermatitis
Sponsor: Bayer
Enrollment: 197
Primary Endpoint: Eczema Area and Severity Index (EASI)
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

May 2011

End Date

September 2011

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bayer

Responsible Party

Sponsor

Eligibility Criteria

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