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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01228513
First received: October 14, 2010
Last updated: December 11, 2014
Last verified: December 2014
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Eczema Area and Severity Index (EASI) [ Time Frame: At baseline ] [ Designated as safety issue: No ]
    Eczema area and severity index

  • EASI [ Time Frame: Measured after one week of treatment ] [ Designated as safety issue: No ]
    Ezcema area and severity index

  • EASI [ Time Frame: Measured at the end of 2 weeks of treatment ] [ Designated as safety issue: No ]
    Eczema area and severity index

  • EASI [ Time Frame: Measured at the end of 3 weeks of treatment ] [ Designated as safety issue: No ]
    Eczema area and severity index

  • EASI [ Time Frame: Measured at the end of 4 weeks of treatment ] [ Designated as safety issue: No ]
    Eczema area and severity index


Secondary Outcome Measures:
  • Subjects' assessment of pruritus [ Time Frame: Measured at baseline ] [ Designated as safety issue: No ]
    Subjective measurement on a point scale

  • Subject's assessment of pruritus [ Time Frame: Measured after one week of treatment ] [ Designated as safety issue: No ]
    Subjective measurement on a point scale

  • Subject's assessment of pruritus [ Time Frame: Measured after two weeks of treatment ] [ Designated as safety issue: No ]
    Subjective measurement on a point scale

  • Subject's assessment of pruritus [ Time Frame: Measured after three weeks of treatment ] [ Designated as safety issue: No ]
    Subjective measurement on a point scale

  • Subject's assessment of pruritus [ Time Frame: Measured after four weeks of treatment ] [ Designated as safety issue: No ]
    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
Active Comparator: 0.03% ointment
Middle concentration
 Drug: ZK245186
Daily topical application
Active Comparator: 0.1% ointment
Highest concentration
 Drug: ZK245186
Daily topical application
Placebo Comparator: Placebo (vehicle without active)
No active ingredient
 Drug: Placebo (vehicle without active ingredient)
Daily topical application

  Eligibility
Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site
Click here to find results for studies related to Bayer Healthcare products.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01228513     History of Changes
Other Study ID Numbers: 15267, 1403380
Study First Received: October 14, 2010
Last Updated: December 11, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on March 03, 2015