Trial Condition(s):
Atopic dermatitis
Efficacy and Safety of Different Concentrations of ZK245186 in Atopic Dermatitis (AD)
Bayer Identifier:
15267
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Mt. Sinai School of Medical New York, United States, 10029 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Advanced Clinical Research Institute, Anaheim, United States, 92801 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations DermResearch, Inc. Austin, United States, 78759 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations J & S Studies, Inc. College Station, United States, 77845 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Minnesota Clinical Study Center Fridley, United States, 55432 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Massachusetts General Women’s Boston, United States, 02114-2508 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Oregon Medical Research Center, PC Portland, United States, 97223 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Northwest Clinical Trial Boise, United States, 83704 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hawaii Clinical Research Center Honolulu, United States, 96813 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Grekin Skin Institute Warren, United States, 48088 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dermatology Clinical Research Center San Antonio, United States, 78229 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Rush University Medical Center Chicago, United States, 60612 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Center for Clinical Studies Webster, United States, 77598 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Skin Clinic Daikanyama Tokyo, Japan, 150-0034 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kawaguchi Kogyo General Hospital Kawaguchi Saitama, Japan, 332-0031 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Research Hospital Tokyo Tokyo, Japan, 162-0053 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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)
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
4
Primary Outcome
- Eczema Area and Severity Index (EASI)Eczema area and severity indexTimeframe: At baseline
- EASIEzcema area and severity indexTimeframe: Measured after one week of treatment
- EASIEczema area and severity indexTimeframe: Measured at the end of 2 weeks of treatment
- EASIEczema area and severity indexTimeframe: Measured at the end of 3 weeks of treatment
- EASIEczema area and severity indexTimeframe: Measured at the end of 4 weeks of treatment
Secondary Outcome
- Subjects' assessment of pruritusSubjective measurement on a point scaleTimeframe: Measured at baseline
- Subject's assessment of pruritusSubjective measurement on a point scaleTimeframe: Measured after one week of treatment
- Subject's assessment of pruritusSubjective measurement on a point scaleTimeframe: Measured after two weeks of treatment
- Subject's assessment of pruritusSubjective measurement on a point scaleTimeframe: Measured after three weeks of treatment
- Subject's assessment of pruritusSubjective measurement on a point scaleTimeframe: Measured after four weeks of treatment
Additional Information
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