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Efficacy and Safety of Different Concentrations of ZK245186 in Atopic Dermatitis (AD)

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ClinicalTrials.gov Identifier: NCT01228513
Recruitment Status : Completed
First Posted : October 26, 2010
Last Update Posted : January 21, 2016
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of three concentrations of a development drug compared to placebo in the treatment of atopic dermatitis.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: ZK245186 Drug: Placebo (vehicle without active ingredient) Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 263 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-blind, Randomized, Vehicle-controlled, Multicenter, Multinational, Parallel-group Study of the Efficacy and Safety of ZK245186 Ointment in Concentrations of 0.01, 0.03, and 0.1% Over 4 Weeks in Patients With Atopic Dermatitis (AD)
Study Start Date : November 2010
Actual Primary Completion Date : July 2011
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 0.01% ointment
Lowest concentration
 Drug: ZK245186
Daily topical application
Other Name: Mapracorat (BAY86-5319)
Active Comparator: 0.03% ointment
Middle concentration
 Drug: ZK245186
Daily topical application
Other Name: Mapracorat (BAY86-5319)
Active Comparator: 0.1% ointment
Highest concentration
 Drug: ZK245186
Daily topical application
Other Name: Mapracorat (BAY86-5319)
Placebo Comparator: Placebo (vehicle without active)
No active ingredient
 Drug: Placebo (vehicle without active ingredient)
Daily topical application


Outcome Measures
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Primary Outcome Measures :
  1. Eczema Area and Severity Index (EASI) [ Time Frame: At baseline ]
    Eczema area and severity index

  2. EASI [ Time Frame: Measured after one week of treatment ]
    Ezcema area and severity index

  3. EASI [ Time Frame: Measured at the end of 2 weeks of treatment ]
    Eczema area and severity index

  4. EASI [ Time Frame: Measured at the end of 3 weeks of treatment ]
    Eczema area and severity index

  5. EASI [ Time Frame: Measured at the end of 4 weeks of treatment ]
    Eczema area and severity index


Secondary Outcome Measures :
  1. Subjects' assessment of pruritus [ Time Frame: Measured at baseline ]
    Subjective measurement on a point scale

  2. Subject's assessment of pruritus [ Time Frame: Measured after one week of treatment ]
    Subjective measurement on a point scale

  3. Subject's assessment of pruritus [ Time Frame: Measured after two weeks of treatment ]
    Subjective measurement on a point scale

  4. Subject's assessment of pruritus [ Time Frame: Measured after three weeks of treatment ]
    Subjective measurement on a point scale

  5. Subject's assessment of pruritus [ Time Frame: Measured after four weeks of treatment ]
    Subjective measurement on a point scale


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of atopic dermatitis according to Hanifin and Rajka criteria
  • Body surface area affected by atopic dermatitis at or less than 15% at start of treatment

Exclusion Criteria:

  • Pregnancy and breast-feeding
  • Conditions that may pose a threat to the patient or effect the outcome of the study
  • Wide-spread atopic dermatitis (AD) requiring systemic treatment
  • Immuno-compromized conditions
  • At least 2 weeks after local AD treatment and treatment with systemic antibiotics
  • At least 1 month after systemic AD treatment
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01228513


Locations
United States, California
Anaheim, California, United States, 92801
United States, Hawaii
Honolulu, Hawaii, United States, 96813
United States, Idaho
Boise, Idaho, United States, 83704
United States, Illinois
Chicago, Illinois, United States, 60612
United States, Massachusetts
Boston, Massachusetts, United States, 02114-2508
United States, Michigan
Warren, Michigan, United States, 48088
United States, Minnesota
Fridley, Minnesota, United States, 55432
United States, New York
New York, New York, United States, 10029
United States, Oregon
Portland, Oregon, United States, 97223
United States, Texas
Austin, Texas, United States, 78759
College Station, Texas, United States, 77845
San Antonio, Texas, United States, 78229
Webster, Texas, United States, 77598
Japan
Kawaguchi Saitama, Japan, 332-0031
Tokyo, Japan, 150-0034
Tokyo, Japan, 162-0053
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site
Click here to find results for studies related to Bayer Healthcare products.  This link exits the ClinicalTrials.gov site

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01228513     History of Changes
Other Study ID Numbers: 15267
1403380 ( Other Identifier: Company Internal )
First Posted: October 26, 2010    Key Record Dates
Last Update Posted: January 21, 2016
Last Verified: December 2015

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