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

NCT ID: NCT01359787

Last Updated: 2015-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

197 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2011-09-30

Brief Summary

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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

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Conditions

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Atopic Dermatitis Eczema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Mapracorat 0.01% Ointment

Lowest concentration

Group Type ACTIVE_COMPARATOR

Mapracorat

Intervention Type DRUG

Daily topical application

Mapracorat 0.03% Ointment

Middle concentration

Group Type ACTIVE_COMPARATOR

Mapracorat

Intervention Type DRUG

Daily topical application

Mapracorat 0.1% Ointment

Highest concentration

Group Type ACTIVE_COMPARATOR

Mapracorat

Intervention Type DRUG

Daily topical application

Vehicle without active

Group Type PLACEBO_COMPARATOR

Vehicle without active

Intervention Type DRUG

Daily topical application

Interventions

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Mapracorat

Daily topical application

Intervention Type DRUG

Vehicle without active

Daily topical application

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Berlin, , Germany

Site Status

Countries

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Germany

Other Identifiers

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1403440

Identifier Type: OTHER

Identifier Source: secondary_id

2010-024279-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

15616

Identifier Type: -

Identifier Source: org_study_id

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