Study Completed

Atopic Dermatitis, Eczema

Bayer Identifier:

15519

ClinicalTrials.gov Identifier:

NCT01407510

EudraCT Number:

Not Available

EU CT Number:

Not Available

HPA axis study in Japanese adults

Trial purpose

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

Key Participants Requirements

Sex

Both

Age

20 - N/A

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

Trial Dates

May 2011 - April 2012

Phase

Phase 2

Could I Receive a placebo

Products

Mapracorat (BAY86-5319)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Kawaguchi Kogyo General Hospital	Saitama, Japan
Completed	Clinical Research Hospital Tokyo	Tokyo, Japan
Terminated	Tokyo Women's Medical University	Tokyo, Japan

Primary Outcome

number of subjects with adrenal suppression
Safety Issue:
Yes

Trial design

A Multicenter, Open-label Study to Evaluate the Adrenal Suppression Potential of Mapracorat 0.1% Ointment in Japanese Adults With Atopic Dermatitis

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

N/A

Blinding

Open Label

Assignment

Single Group Assignment

Trial Arms

Additional Information

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