HPA Axis Study in Japanese Adults

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer

Criteria

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