Efficacy and Safety of Different Concentrations of ZK245186 in Atopic Dermatitis (AD) - Full Text View

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: Double Blind (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:

Genetics Home Reference related topics: atopic dermatitis

MedlinePlus related topics: Eczema

U.S. FDA Resources

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


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

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


Responsible Party:	Bayer
ClinicalTrials.gov Identifier:	NCT01228513 History of Changes
Other Study ID Numbers:	15267 1403380 ( Other Identifier: Company Internal )
Study First Received:	October 14, 2010
Last Updated:	December 17, 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

ClinicalTrials.gov processed this record on June 27, 2017