NCT01228513

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
263

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2010

Shorter than P25 for phase_2

Geographic Reach
2 countries

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2010

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 26, 2010

Completed
6 days until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

January 21, 2016

Status Verified

December 1, 2015

Enrollment Period

8 months

First QC Date

October 14, 2010

Last Update Submit

December 17, 2015

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (5)

  • Subjects' assessment of pruritus

    Measured at baseline

  • Subject's assessment of pruritus

    Measured after one week of treatment

  • Subject's assessment of pruritus

    Measured after two weeks of treatment

  • Subject's assessment of pruritus

    Measured after three weeks of treatment

  • Subject's assessment of pruritus

    Measured after four weeks of treatment

Study Arms (4)

0.01% ointment

ACTIVE COMPARATOR

Lowest concentration

Drug: ZK245186

0.03% ointment

ACTIVE COMPARATOR

Middle concentration

Drug: ZK245186

0.1% ointment

ACTIVE COMPARATOR

Highest concentration

Drug: ZK245186

Placebo (vehicle without active)

PLACEBO COMPARATOR

No active ingredient

Drug: Placebo (vehicle without active ingredient)

Interventions

ZK245186DRUG

Daily topical application

Also known as: Mapracorat (BAY86-5319)
0.01% ointment0.03% ointment0.1% ointment
Placebo (vehicle without active ingredient)DRUG

Daily topical application

Placebo (vehicle without active)

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Unknown Facility

Anaheim, California, 92801, United States

Location

Unknown Facility

Honolulu, Hawaii, 96813, United States

Location

Unknown Facility

Boise, Idaho, 83704, United States

Location

Unknown Facility

Chicago, Illinois, 60612, United States

Location

Unknown Facility

Boston, Massachusetts, 02114-2508, United States

Location

Unknown Facility

Warren, Michigan, 48088, United States

Location

Unknown Facility

Fridley, Minnesota, 55432, United States

Location

Unknown Facility

New York, New York, 10029, United States

Location

Unknown Facility

Portland, Oregon, 97223, United States

Location

Unknown Facility

Austin, Texas, 78759, United States

Location

Unknown Facility

College Station, Texas, 77845, United States

Location

Unknown Facility

San Antonio, Texas, 78229, United States

Location

Unknown Facility

Webster, Texas, 77598, United States

Location

Unknown Facility

Kawaguchi Saitama, 332-0031, Japan

Location

Unknown Facility

Tokyo, 150-0034, Japan

Location

Unknown Facility

Tokyo, 162-0053, Japan

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

R-1,1,1-trifluoro-4-(5-fluoro-2,3-dihydrobenzofuran-7-yl)-4-methyl-2-(((2-methyl-5-quinolyl)amino)methyl)pentan-2-ol

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2010

First Posted

October 26, 2010

Study Start

November 1, 2010

Primary Completion

July 1, 2011

Study Completion

April 1, 2012

Last Updated

January 21, 2016

Record last verified: 2015-12

Locations

US(13)JP(3)