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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

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
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
U.S. FDA Resources

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


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

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 ClinicalTrials.gov identifier (NCT number): NCT01407510


Locations
Japan
Saitama, Japan
Tokyo, Japan
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01407510     History of Changes
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:
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases