search
Back to results

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

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ZK245186
Placebo (vehicle without active ingredient)
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

0.01% ointment

0.03% ointment

0.1% ointment

Placebo (vehicle without active)

Arm Description

Lowest concentration

Middle concentration

Highest concentration

No active ingredient

Outcomes

Primary Outcome Measures

Eczema Area and Severity Index (EASI)
Eczema area and severity index
EASI
Ezcema area and severity index
EASI
Eczema area and severity index
EASI
Eczema area and severity index
EASI
Eczema area and severity index

Secondary Outcome Measures

Subjects' assessment of pruritus
Subjective measurement on a point scale
Subject's assessment of pruritus
Subjective measurement on a point scale
Subject's assessment of pruritus
Subjective measurement on a point scale
Subject's assessment of pruritus
Subjective measurement on a point scale
Subject's assessment of pruritus
Subjective measurement on a point scale

Full Information

First Posted
October 14, 2010
Last Updated
December 17, 2015
Sponsor
Bayer
search

1. Study Identification

Unique Protocol Identification Number
NCT01228513
Brief Title
Efficacy and Safety of Different Concentrations of ZK245186 in Atopic Dermatitis (AD)
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
263 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0.01% ointment
Arm Type
Active Comparator
Arm Description
Lowest concentration
Arm Title
0.03% ointment
Arm Type
Active Comparator
Arm Description
Middle concentration
Arm Title
0.1% ointment
Arm Type
Active Comparator
Arm Description
Highest concentration
Arm Title
Placebo (vehicle without active)
Arm Type
Placebo Comparator
Arm Description
No active ingredient
Intervention Type
Drug
Intervention Name(s)
ZK245186
Other Intervention Name(s)
Mapracorat (BAY86-5319)
Intervention Description
Daily topical application
Intervention Type
Drug
Intervention Name(s)
Placebo (vehicle without active ingredient)
Intervention Description
Daily topical application
Primary Outcome Measure Information:
Title
Eczema Area and Severity Index (EASI)
Description
Eczema area and severity index
Time Frame
At baseline
Title
EASI
Description
Ezcema area and severity index
Time Frame
Measured after one week of treatment
Title
EASI
Description
Eczema area and severity index
Time Frame
Measured at the end of 2 weeks of treatment
Title
EASI
Description
Eczema area and severity index
Time Frame
Measured at the end of 3 weeks of treatment
Title
EASI
Description
Eczema area and severity index
Time Frame
Measured at the end of 4 weeks of treatment
Secondary Outcome Measure Information:
Title
Subjects' assessment of pruritus
Description
Subjective measurement on a point scale
Time Frame
Measured at baseline
Title
Subject's assessment of pruritus
Description
Subjective measurement on a point scale
Time Frame
Measured after one week of treatment
Title
Subject's assessment of pruritus
Description
Subjective measurement on a point scale
Time Frame
Measured after two weeks of treatment
Title
Subject's assessment of pruritus
Description
Subjective measurement on a point scale
Time Frame
Measured after three weeks of treatment
Title
Subject's assessment of pruritus
Description
Subjective measurement on a point scale
Time Frame
Measured after four weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114-2508
Country
United States
City
Warren
State/Province
Michigan
ZIP/Postal Code
48088
Country
United States
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
City
Kawaguchi Saitama
ZIP/Postal Code
332-0031
Country
Japan
City
Tokyo
ZIP/Postal Code
150-0034
Country
Japan
City
Tokyo
ZIP/Postal Code
162-0053
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs