Efficacy and Safety of Different Concentrations of Maprac... | NCT01359787

Studies
Efficacy and Safety of Different Concentrations of Mapracorat Ointment Over 4 Weeks in Atopic Dermatitis (AD)

NCT01359787

Sponsor

Bayer

Status

Completed

Last Update Posted

Jan 21, 2015Estimated

Enrollment

197Actual

Phase

Phase 2

Conditions

Atopic Dermatitis
Eczema

Interventions

Mapracorat
Vehicle without active

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1403440	Other Identifier	Company internal
2010-024279-14	EudraCT Number

Status Module

Record Verification Date

Jan 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2011

Primary Completion Date

Sep 2011Actual

Completion Date

Sep 2011Actual

First Submitted Date

May 23, 2011

First Submission Date that Met QC Criteria

May 24, 2011

First Posted Date

May 25, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 19, 2015

Last Update Posted Date

Jan 21, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

197Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Mapracorat	Drug	Daily topical application	Mapracorat 0.01% Ointment Mapracorat 0.03% Ointment Mapracorat 0.1% Ointment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Eczema Area and Severity Index (EASI)		Over all study visits for up to 4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Subjects´ assessment of pruritus	Subjects´ assessment of pruritus using a visual analog scale (VAS)	At baseline and after 4 weeks of treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D003876	Dermatitis, Atopic
D004485	Eczema

Ancestor Terms

ID	Term
D012873	Skin Diseases, Genetic
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D003872	Dermatitis

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C546413	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
D015444	Exercise

Ancestor Terms

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided