HPA Axis Study in Japanese Adults

This study has been completed.

Sponsor:

Information provided by:

Intendis GmbH

ClinicalTrials.gov Identifier:

NCT01407510

First received: August 1, 2011

Last updated: July 19, 2012

Last verified: February 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	August 1, 2011
Last Updated Date	July 19, 2012
Start Date ^ICMJE	May 2011
Primary Completion Date	September 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 1, 2011)	number of subjects with adrenal suppression [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01407510 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	HPA Axis Study in Japanese Adults
Official Title ^ICMJE	A Multicenter, Open-label Study to Evaluate the Adrenal Suppression Potential of Mapracorat 0.1% Ointment in Japanese Adults With Atopic Dermatitis
Brief Summary	A multicenter, open-label study to evaluate the adrenal suppression potential of Mapracorat 0.1% ointment in Japanese adults with atopic dermatitis.
Detailed Description	Assessment of the adrenal suppression potential, safety, efficacy and pharmacokinetics of Mapracorat 0.1% ointment in Japanese adults with atopic dermatitis.
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Atopic Dermatitis Eczema
Intervention ^ICMJE	Drug: Mapracorat Application of the investigational product on the affected skin areas
Study Arm (s)
Publications *
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	12
Completion Date	April 2012
Primary Completion Date	September 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Signed written informed consent Male or female subject aged >= 20 years Diagnosis of atopic dermatitis according to the 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 investigator's ability to evaluate the subject's response to the investigational product Clinically manifest immunosuppressive disorder or known history of malignant disease
Gender	Both
Ages	20 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Germany

Administrative Information
NCT Number ^ICMJE	NCT01407510
Other Study ID Numbers ^ICMJE	1403460
Has Data Monitoring Committee	No
Responsible Party	Dr. Ulrike Ebert, Study Director, Intendis GmbH
Study Sponsor ^ICMJE	Intendis GmbH
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Intendis GmbH
Verification Date	February 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top