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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.
 
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

Tracking Information
First Submitted Date  ICMJE August 1, 2011
First Posted Date  ICMJE August 2, 2011
Last Update Posted Date February 18, 2015
Study Start Date  ICMJE May 2011
Actual 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
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 Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (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 Arms  ICMJE Experimental: Arm 1
Intervention: Drug: Mapracorat
Publications * Not Provided

*   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
Actual Enrollment  ICMJE
 (submitted: July 19, 2012)
12
Original Estimated Enrollment  ICMJE
 (submitted: August 1, 2011)
10
Actual Study Completion Date  ICMJE April 2012
Actual 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries Germany
 
Administrative Information
NCT Number  ICMJE NCT01407510
Other Study ID Numbers  ICMJE 15519
1403460 ( Other Identifier: Company Internal )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date February 2015

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