Trial Condition(s):

Atopic dermatitis, Eczema

HPA axis study in Japanese adults

Bayer Identifier:

15519

ClinicalTrials.gov Identifier:

NCT01407510

EudraCT Number:

Not Available

Study Completed

Trial Purpose

A multicenter, open-label study to evaluate the adrenal suppression potential 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

Trial Summary

Enrollment Goal
12
Trial Dates
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Phase
2
Could I receive a placebo?
No
Products
Mapracorat (BAY86-5319)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Kawaguchi Kogyo General Hospital

Saitama, Japan

Status
Completed
 
Locations

Clinical Research Hospital Tokyo

Tokyo, Japan

Status
Completed
 
Locations

Tokyo Women's Medical University

Tokyo, Japan

Status
Terminated
 

Trial Design