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

NCT ID: NCT01228513

Last Updated: 2016-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

263 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2012-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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0.01% ointment

Lowest concentration

Group Type ACTIVE_COMPARATOR

ZK245186

Intervention Type DRUG

Daily topical application

0.03% ointment

Middle concentration

Group Type ACTIVE_COMPARATOR

ZK245186

Intervention Type DRUG

Daily topical application

0.1% ointment

Highest concentration

Group Type ACTIVE_COMPARATOR

ZK245186

Intervention Type DRUG

Daily topical application

Placebo (vehicle without active)

No active ingredient

Group Type PLACEBO_COMPARATOR

Placebo (vehicle without active ingredient)

Intervention Type DRUG

Daily topical application

Interventions

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ZK245186

Daily topical application

Intervention Type DRUG

Placebo (vehicle without active ingredient)

Daily topical application

Intervention Type DRUG

Other Intervention Names

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Mapracorat (BAY86-5319)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Anaheim, California, United States

Site Status

Honolulu, Hawaii, United States

Site Status

Boise, Idaho, United States

Site Status

Chicago, Illinois, United States

Site Status

Boston, Massachusetts, United States

Site Status

Warren, Michigan, United States

Site Status

Fridley, Minnesota, United States

Site Status

New York, New York, United States

Site Status

Portland, Oregon, United States

Site Status

Austin, Texas, United States

Site Status

College Station, Texas, United States

Site Status

San Antonio, Texas, United States

Site Status

Webster, Texas, United States

Site Status

Kawaguchi Saitama, , Japan

Site Status

Tokyo, , Japan

Site Status

Tokyo, , Japan

Site Status

Countries

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United States Japan

Other Identifiers

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1403380

Identifier Type: OTHER

Identifier Source: secondary_id

15267

Identifier Type: -

Identifier Source: org_study_id

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