Trial Condition(s):
Atopic dermatitis
Efficacy and Safety of Different Concentrations of ZK245186 in Atopic Dermatitis (AD)
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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