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

Bayer197 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

197

Conditions

Atopic Dermatitis Eczema

Interventions

MapracoratDRUG

Daily topical application

Vehicle without activeDRUG

Daily topical application

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Berlin, Germany

Outcomes

Primary Outcomes

Eczema Area and Severity Index (EASI)

Time frame: Over all study visits for up to 4 weeks

Secondary Outcomes

Subjects´ assessment of pruritus

Subjects´ assessment of pruritus using a visual analog scale (VAS)

Time frame: At baseline and after 4 weeks of treatment

Data from ClinicalTrials.gov

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