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
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 April 14, 2014