Back to resultsHPA Axis Study in Adults
Primary Purpose
Atopic Dermatitis, Eczema
Status
Completed
Phase
Phase 2
Locations
South Africa
Study Type
Interventional
Intervention
Mapracorat
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis
Eligibility Criteria
Inclusion Criteria:
- Signed written informed consent
- Male or female subject aged >= 18 years
- Diagnosis of atopic dermatitis according to 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 study conduct or the evaluation and interpretation of the study results
- Clinically manifest immunosuppressive disorder or known history of malignant disease
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm 1
Arm Description
Outcomes
Primary Outcome Measures
HPA axis response to Cosyntropin: Number of subjects with adrenal suppression
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01408511
Brief Title
HPA Axis Study in Adults
Official Title
A Multicenter, Open Label Study to Evaluate the Adrenal Suppression Potential of Mapracorat 0.1% Ointment in Adults With Atopic Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A multicenter, open-label study to evaluate the adrenal suppression potential of Mapracorat 0.1% ointment in adults with atopic dermatitis.
Detailed Description
Assessment of safety, efficacy, pharmacokinetics and adrenal suppression potential of Mapracorat 0.1% ointment in adults with atopic dermatitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis, Eczema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Mapracorat
Intervention Description
Application of the investigational product on the affected skin areas
Primary Outcome Measure Information:
Title
HPA axis response to Cosyntropin: Number of subjects with adrenal suppression
Time Frame
measured after 4 weeks of therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed written informed consent
Male or female subject aged >= 18 years
Diagnosis of atopic dermatitis according to 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 study conduct or the evaluation and interpretation of the study results
Clinically manifest immunosuppressive disorder or known history of malignant disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Bloemfontein
Country
South Africa
City
George
Country
South Africa
City
Port Elizabeth
Country
South Africa
12. IPD Sharing Statement
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HPA Axis Study in Adults
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