Trial Condition(s):

Atopic dermatitis, Eczema

HPA Axis Study in Adults

Bayer Identifier:

15446

ClinicalTrials.gov Identifier:

NCT01408511

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 adults with atopic dermatitis.

Inclusion Criteria
- Signed written informed consent
- Male or female subject aged >= 18 years
- Diagnosis of atopic dermatitis according to 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 study conduct or the evaluation and interpretation of the study results
- Clinically manifest immunosuppressive disorder or known history of malignant disease

Trial Summary

Enrollment Goal
23
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

PAREXEL Bloemfontein

Bloemfontein, South Africa

Status
Completed
 
Locations

PAREXEL George

George, South Africa

Status
Completed
 
Locations

PAREXEL Port Elizabeth

Port Elizabeth, South Africa

Status
Completed
 

Trial Design