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

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
|
- Eczema Area and Severity Index (EASI) [ Time Frame: At baseline ]Eczema area and severity index
- EASI [ Time Frame: Measured after one week of treatment ]Ezcema area and severity index
- EASI [ Time Frame: Measured at the end of 2 weeks of treatment ]Eczema area and severity index
- EASI [ Time Frame: Measured at the end of 3 weeks of treatment ]Eczema area and severity index
- EASI [ Time Frame: Measured at the end of 4 weeks of treatment ]Eczema area and severity index
- Subjects' assessment of pruritus [ Time Frame: Measured at baseline ]Subjective measurement on a point scale
- Subject's assessment of pruritus [ Time Frame: Measured after one week of treatment ]Subjective measurement on a point scale
- Subject's assessment of pruritus [ Time Frame: Measured after two weeks of treatment ]Subjective measurement on a point scale
- Subject's assessment of pruritus [ Time Frame: Measured after three weeks of treatment ]Subjective measurement on a point scale
- Subject's assessment of pruritus [ Time Frame: Measured after four weeks of treatment ]Subjective measurement on a point scale

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

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
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 |
Study Director: | Bayer Study Director | Bayer |
Additional Information:
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 |