HPA Axis Study in Japanese Adults (NCT01407510) | Clinical Trial Compass
CompletedPhase 2
HPA Axis Study in Japanese Adults
Japan12 participantsStarted 2011-05-09
Plain-language summary
A multicenter, open-label study to evaluate the adrenal suppression potential of Mapracorat 0.1% ointment in Japanese adults with atopic dermatitis.
Who can participate
Age range20 Years
SexALL
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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