HPA Axis Study in Adults
A multicenter, open-label study to evaluate the adrenal suppression potential of Mapracorat 0.1% ointment in 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 Adults With Atopic Dermatitis|
- HPA axis response to Cosyntropin: Number of subjects with adrenal suppression [ Time Frame: measured after 4 weeks of therapy ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2011|
|Study Completion Date:||July 2012|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
|Experimental: Arm 1||
Application of the investigational product on the affected skin areas
Assessment of safety, efficacy, pharmacokinetics and adrenal suppression potential of Mapracorat 0.1% ointment in adults with atopic dermatitis.