We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01228513
First Posted: October 26, 2010
Last Update Posted: January 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
  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.

Condition Intervention Phase
Atopic Dermatitis Drug: ZK245186 Drug: Placebo (vehicle without active ingredient) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Eczema Area and Severity Index (EASI) [ Time Frame: At baseline ]
    Eczema area and severity index

  • EASI [ Time Frame: Measured after one week of treatment ]
    Ezcema area and severity index

  • EASI [ Time Frame: Measured at the end of 2 weeks of treatment ]
    Eczema area and severity index

  • EASI [ Time Frame: Measured at the end of 3 weeks of treatment ]
    Eczema area and severity index

  • EASI [ Time Frame: Measured at the end of 4 weeks of treatment ]
    Eczema area and severity index


Secondary Outcome Measures:
  • Subjects' assessment of pruritus [ Time Frame: Measured at baseline ]
    Subjective measurement on a point scale

  • Subject's assessment of pruritus [ Time Frame: Measured after one week of treatment ]
    Subjective measurement on a point scale

  • Subject's assessment of pruritus [ Time Frame: Measured after two weeks of treatment ]
    Subjective measurement on a point scale

  • Subject's assessment of pruritus [ Time Frame: Measured after three weeks of treatment ]
    Subjective measurement on a point scale

  • Subject's assessment of pruritus [ Time Frame: Measured after four weeks of treatment ]
    Subjective measurement on a point scale


Enrollment: 263
Study Start Date: November 2010
Study Completion Date: April 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 0.01% ointment
Lowest concentration
Drug: ZK245186
Daily topical application
Other Name: Mapracorat (BAY86-5319)
Active Comparator: 0.03% ointment
Middle concentration
Drug: ZK245186
Daily topical application
Other Name: Mapracorat (BAY86-5319)
Active Comparator: 0.1% ointment
Highest concentration
Drug: ZK245186
Daily topical application
Other Name: Mapracorat (BAY86-5319)
Placebo Comparator: Placebo (vehicle without active)
No active ingredient
Drug: Placebo (vehicle without active ingredient)
Daily topical application

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01228513


Locations
United States, California
Anaheim, California, United States, 92801
United States, Hawaii
Honolulu, Hawaii, United States, 96813
United States, Idaho
Boise, Idaho, United States, 83704
United States, Illinois
Chicago, Illinois, United States, 60612
United States, Massachusetts
Boston, Massachusetts, United States, 02114-2508
United States, Michigan
Warren, Michigan, United States, 48088
United States, Minnesota
Fridley, Minnesota, United States, 55432
United States, New York
New York, New York, United States, 10029
United States, Oregon
Portland, Oregon, United States, 97223
United States, Texas
Austin, Texas, United States, 78759
College Station, Texas, United States, 77845
San Antonio, Texas, United States, 78229
Webster, Texas, United States, 77598
Japan
Kawaguchi Saitama, Japan, 332-0031
Tokyo, Japan, 150-0034
Tokyo, Japan, 162-0053
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01228513     History of Changes
Other Study ID Numbers: 15267
1403380 ( Other Identifier: Company Internal )
First Submitted: October 14, 2010
First Posted: October 26, 2010
Last Update Posted: January 21, 2016
Last Verified: December 2015

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases