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HPA Axis Study in Japanese Adults

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ClinicalTrials.gov Identifier: NCT01407510
Recruitment Status : Completed
First Posted : August 2, 2011
Last Update Posted : February 18, 2015
Sponsor:
Information provided by (Responsible Party):
Bayer

August 1, 2011
August 2, 2011
February 18, 2015
May 2011
September 2011   (Final data collection date for primary outcome measure)
number of subjects with adrenal suppression
Same as current
Complete list of historical versions of study NCT01407510 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
HPA Axis Study in Japanese Adults
A Multicenter, Open-label Study to Evaluate the Adrenal Suppression Potential of Mapracorat 0.1% Ointment in Japanese Adults With Atopic Dermatitis
A multicenter, open-label study to evaluate the adrenal suppression potential of Mapracorat 0.1% ointment in Japanese adults with atopic dermatitis.
Assessment of the adrenal suppression potential, safety, efficacy and pharmacokinetics of Mapracorat 0.1% ointment in Japanese adults with atopic dermatitis.
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Atopic Dermatitis
  • Eczema
Drug: Mapracorat
Application of the investigational product on the affected skin areas
Experimental: Arm 1
Intervention: Drug: Mapracorat
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
10
April 2012
September 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Japan
Germany
 
NCT01407510
15519
1403460 ( Other Identifier: Company Internal )
No
Not Provided
Not Provided
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP