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

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

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

Inclusion Criteria:

• 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 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 investigator's ability to evaluate the subject's response to the investigational product
• Clinically manifest immunosuppressive disorder or known history of malignant disease