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

Phase 2

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: ZK245186; Drug: Placebo (vehicle without active ingredient)

• Registration Number: NCT01228513
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-14
• Study First Submitted QC: 2010-10-25
• Study First Posted: 2010-10-26
• Study Start: 2010-11
• Primary Completion: 2011-07
• Study Completion: 2012-04
• Disposition First Submitted: 2015-06-04
• Disposition First Submitted QC: 2015-06-04
• Disposition First Posted: 2015-07-01
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-17
• Last Update Posted: 2016-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 263

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.01% ointment	ZK245186	Lowest concentration
0.03% ointment	ZK245186	Middle concentration
0.1% ointment	ZK245186	Highest concentration
Placebo (vehicle without active)	Placebo (vehicle without active ingredient)	No active ingredient

Primary Outcome Measures

Name	Time	Method
Eczema Area and Severity Index (EASI)	At baseline	Eczema area and severity index
EASI	Measured at the end of 4 weeks of treatment	Eczema area and severity index

Secondary Outcome Measures

Name	Time	Method
Subjects' assessment of pruritus	Measured at baseline	Subjective measurement on a point scale
Subject's assessment of pruritus	Measured after four weeks of treatment	Subjective measurement on a point scale