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

A multicenter, open-label study to evaluate the adrenal suppression potential of Mapracorat 0.1% ointment in adults with atopic dermatitis.

Assessment of safety, efficacy, pharmacokinetics and adrenal suppression potential of Mapracorat 0.1% ointment in adults with atopic dermatitis.

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