HPA Axis Study in Adults | NCT01408511

Studies
HPA Axis Study in Adults

NCT01408511

Sponsor

Bayer

Status

Completed

Last Update Posted

Oct 31, 2023Actual

Enrollment

23Actual

Phase

Phase 2

Conditions

Atopic Dermatitis
Eczema

Interventions

Mapracorat

Countries

South Africa

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
1403161	Other Identifier	Company Internal

Status Module

Record Verification Date

Oct 2023

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

Jul 19, 2011Actual

Primary Completion Date

Dec 15, 2011Actual

Completion Date

Dec 21, 2011Actual

First Submitted Date

Aug 1, 2011

First Submission Date that Met QC Criteria

Aug 2, 2011

First Posted Date

Aug 3, 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

Oct 30, 2023

Last Update Posted Date

Oct 31, 2023Actual

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

A multicenter, open-label study to evaluate the adrenal suppression potential of Mapracorat 0.1% ointment in adults with atopic dermatitis.

Detailed Description

Assessment of safety, efficacy, pharmacokinetics and adrenal suppression potential of Mapracorat 0.1% ointment in adults with atopic dermatitis.

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

23Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Experimental		Drug: Mapracorat

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mapracorat	Drug	Application of the investigational product on the affected skin areas	Arm 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HPA axis response to Cosyntropin: Number of subjects with adrenal suppression		measured after 4 weeks of therapy

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed written informed consent
Male or female subject aged >= 18 years
Diagnosis of atopic dermatitis according to Hanifin and Rajka Criteria
Investigator's Global Assessment (IGA) score of 3 (moderate) to 4 (severe) at baseline
Normal ACTH response before start of treatment

Exclusion Criteria:

Pregnancy or lactation
Clinically relevant disease, which could interfere with the study conduct or the evaluation and interpretation of the study results
Concomitant medical or dermatological disorder(s), which could interfere with the study conduct or the evaluation and interpretation of the study results
Clinically manifest immunosuppressive disorder or known history of malignant disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
PAREXEL Bloemfontein		Bloemfontein			South Africa
PAREXEL George

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

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided