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

Primary Purpose

Atopic Dermatitis, Eczema

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Mapracorat
Vehicle without active
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Mapracorat 0.01% Ointment

Mapracorat 0.03% Ointment

Mapracorat 0.1% Ointment

Vehicle without active

Arm Description

Lowest concentration

Middle concentration

Highest concentration

Outcomes

Primary Outcome Measures

Eczema Area and Severity Index (EASI)

Secondary Outcome Measures

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

Full Information

First Posted
May 23, 2011
Last Updated
January 19, 2015
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT01359787
Brief Title
Efficacy and Safety of Different Concentrations of Mapracorat Ointment Over 4 Weeks in Atopic Dermatitis (AD)
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis, Eczema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
197 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mapracorat 0.01% Ointment
Arm Type
Active Comparator
Arm Description
Lowest concentration
Arm Title
Mapracorat 0.03% Ointment
Arm Type
Active Comparator
Arm Description
Middle concentration
Arm Title
Mapracorat 0.1% Ointment
Arm Type
Active Comparator
Arm Description
Highest concentration
Arm Title
Vehicle without active
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Mapracorat
Intervention Description
Daily topical application
Intervention Type
Drug
Intervention Name(s)
Vehicle without active
Intervention Description
Daily topical application
Primary Outcome Measure Information:
Title
Eczema Area and Severity Index (EASI)
Time Frame
Over all study visits for up to 4 weeks
Secondary Outcome Measure Information:
Title
Subjects´ assessment of pruritus
Description
Subjects´ assessment of pruritus using a visual analog scale (VAS)
Time Frame
At baseline and after 4 weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Berlin
ZIP/Postal Code
10589
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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