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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: ZK245186
* Drug: Placebo (vehicle without active ingredient)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 0.01% ointment<br>Lowest concentration | Drug: ZK245186<br>* Daily topical application<br>* Other names: Mapracorat (BAY86-5319);|
| Active Comparator: 0.03% ointment<br>Middle concentration | Drug: ZK245186<br>* Daily topical application<br>* Other names: Mapracorat (BAY86-5319);|
| Active Comparator: 0.1% ointment<br>Highest concentration | Drug: ZK245186<br>* Daily topical application<br>* Other names: Mapracorat (BAY86-5319);|
| Placebo Comparator: Placebo (vehicle without active)<br>No active ingredient | Drug: Placebo (vehicle without active ingredient)<br>* Daily topical application<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eczema Area and Severity Index (EASI) | Eczema area and severity index | At baseline | 
| EASI | Ezcema area and severity index | Measured after one week of treatment | 
| EASI | Eczema area and severity index | Measured at the end of 2 weeks of treatment | 
| EASI | Eczema area and severity index | Measured at the end of 3 weeks of treatment | 
| EASI | Eczema area and severity index | Measured at the end of 4 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects' assessment of pruritus | Subjective measurement on a point scale | Measured at baseline | 
| Subject's assessment of pruritus | Subjective measurement on a point scale | Measured after one week of treatment | 
| Subject's assessment of pruritus | Subjective measurement on a point scale | Measured after two weeks of treatment | 
| Subject's assessment of pruritus | Subjective measurement on a point scale | Measured after three weeks of treatment | 
| Subject's assessment of pruritus | Subjective measurement on a point scale | Measured after four weeks of treatment |