NCT01359787

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of three concentrations of a development drug compared to ointment base (vehicle) in subjects with Atopic Dermatitis (AD).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
197

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

May 1, 2011

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

May 23, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 25, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

January 21, 2015

Status Verified

January 1, 2015

Enrollment Period

4 months

First QC Date

May 23, 2011

Last Update Submit

January 19, 2015

Conditions

Atopic DermatitisEczema

Outcome Measures

Primary Outcomes (1)

  • Eczema Area and Severity Index (EASI)

    Over all study visits for up to 4 weeks

Secondary Outcomes (1)

  • Subjects´ assessment of pruritus

    At baseline and after 4 weeks of treatment

Study Arms (4)

Mapracorat 0.01% Ointment

ACTIVE COMPARATOR

Lowest concentration

Drug: Mapracorat

Mapracorat 0.03% Ointment

ACTIVE COMPARATOR

Middle concentration

Drug: Mapracorat

Mapracorat 0.1% Ointment

ACTIVE COMPARATOR

Highest concentration

Drug: Mapracorat

Vehicle without active

PLACEBO COMPARATOR
Drug: Vehicle without active

Interventions

MapracoratDRUG

Daily topical application

Mapracorat 0.01% OintmentMapracorat 0.03% OintmentMapracorat 0.1% Ointment
Vehicle without activeDRUG

Daily topical application

Vehicle without active

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed written informed consent
  • Diagnosis of atopic dermatitis according to Hanifin and Rajka Criteria
  • Willingness of subject to follow all study procedures
  • Willingness to avoid excessive exposure of diseased areas to natural or artificial sunlight

You may not qualify if:

  • Pregnancy and breast-feeding
  • Clinically relevant disease, which could interfere with the study conduct or the evaluation and interpretation of the study results
  • Clinically manifested immunosuppressive disorder or known history of malignant disease
  • History of relevant drug and/or food allergies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Berlin, 10589, Germany

Location

MeSH Terms

Conditions

Dermatitis, AtopicEczema

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-olExercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

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

May 23, 2011

First Posted

May 25, 2011

Study Start

May 1, 2011

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

January 21, 2015

Record last verified: 2015-01

Locations

DE(1)