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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:
Intendis GmbH
ClinicalTrials.gov Identifier:
NCT01359787
First received: May 23, 2011
Last updated: July 23, 2012
Last verified: December 2010
History of Changes

May 23, 2011
July 23, 2012
May 2011
September 2011   (final data collection date for primary outcome measure)
Eczema Area and Severity Index (EASI) [ Time Frame: Over all study visits for up to 4 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01359787 on ClinicalTrials.gov Archive Site
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)
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Different Concentrations of Mapracorat Ointment Over 4 Weeks in Atopic Dermatitis (AD)
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).
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Atopic Dermatitis
  • Eczema
  • Drug: Mapracorat
    Daily topical application
  • Drug: Vehicle without active
    Daily topical application
  • Active Comparator: Mapracorat 0.01% Ointment
    Lowest concentration
    Intervention: Drug: Mapracorat
  • Active Comparator: Mapracorat 0.03% Ointment
    Middle concentration
    Intervention: Drug: Mapracorat
  • Active Comparator: Mapracorat 0.1% Ointment
    Highest concentration
    Intervention: Drug: Mapracorat
  • Placebo Comparator: Vehicle without active
    Intervention: Drug: Vehicle without active
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
197
June 2012
September 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01359787
1403440
No
Dr. Kathrin Vick, Study Director, Intendis GmbH
Intendis GmbH
Not Provided
Study Director: Kathrin Vick, MD Intendis GmbH, Berlin, Germany
Intendis GmbH
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP