Trial Condition(s):

Atopic dermatitis

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

Bayer Identifier:

15267

ClinicalTrials.gov Identifier:

NCT01228513

EudraCT Number:

Not Available

EU CT Number:

Not Available

Study Completed

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
263
Trial Dates
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Phase
2
Could I receive a placebo?
Yes
Products
Mapracorat (BAY86-5319)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Mt. Sinai School of Medical

New York, United States, 10029

Status
Completed
Locations

Advanced Clinical Research Institute,

Anaheim, United States, 92801

Status
Completed
Locations

DermResearch, Inc.

Austin, United States, 78759

Status
Completed
Locations

J & S Studies, Inc.

College Station, United States, 77845

Status
Completed
Locations

Minnesota Clinical Study Center

Fridley, United States, 55432

Status
Completed
Locations

Massachusetts General Women’s

Boston, United States, 02114-2508

Status
Completed
Locations

Oregon Medical Research Center, PC

Portland, United States, 97223

Status
Completed
Locations

Northwest Clinical Trial

Boise, United States, 83704

Status
Completed
Locations

Hawaii Clinical Research Center

Honolulu, United States, 96813

Status
Completed
Locations

Grekin Skin Institute

Warren, United States, 48088

Status
Completed
Locations

Dermatology Clinical Research Center

San Antonio, United States, 78229

Status
Completed
Locations

Rush University Medical Center

Chicago, United States, 60612

Status
Completed
Locations

Center for Clinical Studies

Webster, United States, 77598

Status
Completed
Locations

Skin Clinic Daikanyama

Tokyo, Japan, 150-0034

Status
Completed
Locations

Kawaguchi Kogyo General Hospital

Kawaguchi Saitama, Japan, 332-0031

Status
Completed
Locations

Clinical Research Hospital Tokyo

Tokyo, Japan, 162-0053

Status
Completed

Trial Design