check_circleStudy Completed

Atopic Dermatitis, Eczema

Bayer Identifier:

15616

ClinicalTrials.gov Identifier:

NCT01359787

EudraCT Number:

2010-024279-14

EU CT Number:

Not Available
Efficacy and Safety of Different Concentrations of Mapracorat Ointment Over 4 Weeks in Atopic Dermatitis (AD)

Trial 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).

Key Participants Requirements

Sex

Both

Age

18 - 65 Years
  • - 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
  • - 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

Trial summary

Enrollment Goal
197
Trial Dates
May 2011 - September 2011
Phase
Phase 2
Could I Receive a placebo
No
Products
Mapracorat (BAY86-5319)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Intendis GmbHBerlin, 10589, Germany

Primary Outcome

  • Eczema Area and Severity Index (EASI)
    date_rangeTime Frame:
    Over all study visits for up to 4 weeks
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    Safety Issue:
    No

Secondary Outcome

  • Subjects´ assessment of pruritus
    Subjects´ assessment of pruritus using a visual analog scale (VAS)
    date_rangeTime Frame:
    At baseline and after 4 weeks of treatment
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    Safety Issue:
    No

Trial design

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)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
4

Additional Information

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