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

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)

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.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: ZK245186; Drug: Placebo (vehicle without active ingredient)

• Study Type: Interventional
• Enrollment (Actual): 263
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 0.01% ointment; Lowest concentration	Drug: ZK245186; Daily topical application; Other Names: Mapracorat (BAY86-5319)
Active Comparator: 0.03% ointment; Middle concentration	Drug: ZK245186; Daily topical application; Other Names: Mapracorat (BAY86-5319)
Active Comparator: 0.1% ointment; Highest concentration	Drug: ZK245186; Daily topical application; Other Names: Mapracorat (BAY86-5319)
Placebo Comparator: Placebo (vehicle without active); No active ingredient	Drug: Placebo (vehicle without active ingredient); Daily topical application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eczema Area and Severity Index (EASI)	Eczema area and severity index	At baseline
EASI	Ezcema area and severity index	Measured after one week of treatment
EASI	Eczema area and severity index	Measured at the end of 2 weeks of treatment
EASI	Eczema area and severity index	Measured at the end of 3 weeks of treatment
EASI	Eczema area and severity index	Measured at the end of 4 weeks of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjects' assessment of pruritus	Subjective measurement on a point scale	Measured at baseline
Subject's assessment of pruritus	Subjective measurement on a point scale	Measured after one week of treatment
Subject's assessment of pruritus	Subjective measurement on a point scale	Measured after two weeks of treatment
Subject's assessment of pruritus	Subjective measurement on a point scale	Measured after three weeks of treatment
Subject's assessment of pruritus	Subjective measurement on a point scale	Measured after four weeks of treatment

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: October 14, 2010
• First Submitted That Met QC Criteria: October 25, 2010
• First Posted (Estimate): October 26, 2010

Study Record Updates

• Last Update Posted (Estimate): January 21, 2016
• Last Update Submitted That Met QC Criteria: December 17, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: 15267; 1403380 (Other Identifier: Company Internal)