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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01359787
First received: May 23, 2011
Last updated: February 20, 2014
Last verified: February 2014
  Purpose

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).


Condition Intervention Phase
Atopic Dermatitis
Eczema
Drug: Mapracorat
Drug: Vehicle without active
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Eczema Area and Severity Index (EASI) [ Time Frame: Over all study visits for up to 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subjects´ assessment of pruritus [ Time Frame: At baseline and after 4 weeks of treatment ] [ Designated as safety issue: No ]
    Subjects´ assessment of pruritus using a visual analog scale (VAS)


Enrollment: 197
Study Start Date: May 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01359787

Locations
Germany
Intendis GmbH
Berlin, Germany, 10589
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01359787     History of Changes
Other Study ID Numbers: 15616, 1403440
Study First Received: May 23, 2011
Last Updated: February 20, 2014
Health Authority: Czech Republic: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Latvia: State Agency of Medicines
Poland: Ministry of Health

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 24, 2014