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

January 19, 2015 updated by: Bayer

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)

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

197

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Mapracorat 0.01% Ointment
Lowest concentration
Drug: Mapracorat
Daily topical application
Active Comparator: Mapracorat 0.03% Ointment
Middle concentration
Drug: Mapracorat
Daily topical application
Active Comparator: Mapracorat 0.1% Ointment
Highest concentration
Drug: Mapracorat
Daily topical application
Placebo Comparator: Vehicle without active
Drug: Vehicle without active
Daily topical application

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Eczema Area and Severity Index (EASI)
Time Frame: Over all study visits for up to 4 weeks
Over all study visits for up to 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjects´ assessment of pruritus
Time Frame: At baseline and after 4 weeks of treatment
Subjects´ assessment of pruritus using a visual analog scale (VAS)
At baseline and after 4 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

May 23, 2011

First Submitted That Met QC Criteria

May 24, 2011

First Posted (Estimate)

May 25, 2011

Study Record Updates

Last Update Posted (Estimate)

January 21, 2015

Last Update Submitted That Met QC Criteria

January 19, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15616
  • 1403440 (Other Identifier: Company internal)
  • 2010-024279-14 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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