HPA Axis Study in Japanese Adults
A multicenter, open-label study to evaluate the adrenal suppression potential of Mapracorat 0.1% ointment in Japanese adults with atopic dermatitis.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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|
- number of subjects with adrenal suppression [ Designated as safety issue: Yes ]
|Study Start Date:||May 2011|
|Study Completion Date:||April 2012|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
|Experimental: Arm 1||
Application of the investigational product on the affected skin areas
Assessment of the adrenal suppression potential, safety, efficacy and pharmacokinetics of Mapracorat 0.1% ointment in Japanese adults with atopic dermatitis.