NCT01228513
Completed
Phase 2
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)
ConditionsAtopic Dermatitis
Overview
- Phase
- Phase 2
- Intervention
- ZK245186
- Conditions
- Atopic Dermatitis
- Sponsor
- Bayer
- Enrollment
- 263
- Primary Endpoint
- Eczema Area and Severity Index (EASI)
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility 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
Arms & Interventions
0.01% ointment
Lowest concentration
Intervention: ZK245186
0.03% ointment
Middle concentration
Intervention: ZK245186
0.1% ointment
Highest concentration
Intervention: ZK245186
Placebo (vehicle without active)
No active ingredient
Intervention: Placebo (vehicle without active ingredient)
Outcomes
Primary Outcomes
Eczema Area and Severity Index (EASI)
Time Frame: At baseline
Eczema area and severity index
EASI
Time Frame: Measured at the end of 4 weeks of treatment
Eczema area and severity index
Secondary Outcomes
- Subjects' assessment of pruritus(Measured at baseline)
- Subject's assessment of pruritus(Measured after four weeks of treatment)
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