Status:
COMPLETED
HPA Axis Study in Japanese Adults
Lead Sponsor:
Bayer
Conditions:
Atopic Dermatitis
Eczema
Eligibility:
All Genders
20+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 9 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2012
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01407510
Start Date
May 9 2011
End Date
April 15 2012
Last Update
September 21 2023
Active Locations (3)
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1
Kawaguchi Kogyo General Hospital
Saitama, Japan
2
Clinical Research Hospital Tokyo
Tokyo, Japan
3
Tokyo Women's Medical University
Tokyo, Japan