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HPA Axis Study in Japanese Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01407510
Recruitment Status : Completed
First Posted : August 2, 2011
Last Update Posted : February 18, 2015
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Eczema Drug: Mapracorat Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label Study to Evaluate the Adrenal Suppression Potential of Mapracorat 0.1% Ointment in Japanese Adults With Atopic Dermatitis
Study Start Date : May 2011
Actual Primary Completion Date : September 2011
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: Arm 1 Drug: Mapracorat
Application of the investigational product on the affected skin areas

Primary Outcome Measures :
  1. number of subjects with adrenal suppression

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01407510

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Saitama, Japan
Tokyo, Japan
Sponsors and Collaborators
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Study Director: Bayer Study Director Bayer
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Responsible Party: Bayer Identifier: NCT01407510    
Other Study ID Numbers: 15519
1403460 ( Other Identifier: Company Internal )
First Posted: August 2, 2011    Key Record Dates
Last Update Posted: February 18, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases