check_circleStudy Completed

Atopic Dermatitis

Bayer Identifier:
15267
ClinicalTrials.gov Identifier:
NCT01228513
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.

Key Participants Requirements

Sex

Both

Age

18 - 55 Years
  • - 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
  • - 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
263
Trial Dates
November 2010 - April 2012
Phase
Phase 2
Could I Receive a placebo
Yes
Products
Mapracorat (BAY86-5319)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Mt. Sinai School of MedicalNew York, 10029, United States
Completed
Advanced Clinical Research Institute,Anaheim, 92801, United States
Completed
DermResearch, Inc.Austin, 78759, United States
Completed
J & S Studies, Inc.College Station, 77845, United States
Completed
Minnesota Clinical Study CenterFridley, 55432, United States
Completed
Massachusetts General Women’sBoston, 02114-2508, United States
Completed
Oregon Medical Research Center, PCPortland, 97223, United States
Completed
Northwest Clinical TrialBoise, 83704, United States
Completed
Hawaii Clinical Research CenterHonolulu, 96813, United States
Completed
Grekin Skin InstituteWarren, 48088, United States
Completed
Dermatology Clinical Research CenterSan Antonio, 78229, United States
Completed
Rush University Medical CenterChicago, 60612, United States
Completed
Center for Clinical StudiesWebster, 77598, United States
Completed
Skin Clinic DaikanyamaTokyo, 150-0034, Japan
Completed
Kawaguchi Kogyo General HospitalKawaguchi Saitama, 332-0031, Japan
Completed
Clinical Research Hospital TokyoTokyo, 162-0053, Japan

Primary Outcome

  • Eczema Area and Severity Index (EASI)
    Eczema area and severity index
    date_rangeTime Frame:
    At baseline
    enhanced_encryption
    Safety Issue:
    No
  • EASI
    Ezcema area and severity index
    date_rangeTime Frame:
    Measured after one week of treatment
    enhanced_encryption
    Safety Issue:
    No
  • EASI
    Eczema area and severity index
    date_rangeTime Frame:
    Measured at the end of 2 weeks of treatment
    enhanced_encryption
    Safety Issue:
    No
  • EASI
    Eczema area and severity index
    date_rangeTime Frame:
    Measured at the end of 3 weeks of treatment
    enhanced_encryption
    Safety Issue:
    No
  • EASI
    Eczema area and severity index
    date_rangeTime Frame:
    Measured at the end of 4 weeks of treatment
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Subjects' assessment of pruritus
    Subjective measurement on a point scale
    date_rangeTime Frame:
    Measured at baseline
    enhanced_encryption
    Safety Issue:
    No
  • Subject's assessment of pruritus
    Subjective measurement on a point scale
    date_rangeTime Frame:
    Measured after one week of treatment
    enhanced_encryption
    Safety Issue:
    No
  • Subject's assessment of pruritus
    Subjective measurement on a point scale
    date_rangeTime Frame:
    Measured after two weeks of treatment
    enhanced_encryption
    Safety Issue:
    No
  • Subject's assessment of pruritus
    Subjective measurement on a point scale
    date_rangeTime Frame:
    Measured after three weeks of treatment
    enhanced_encryption
    Safety Issue:
    No
  • Subject's assessment of pruritus
    Subjective measurement on a point scale
    date_rangeTime Frame:
    Measured after four weeks of treatment
    enhanced_encryption
    Safety Issue:
    No

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

Additional Information

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