Trial Condition(s):

Atopic dermatitis, Eczema

HPA Axis Study in Adults

Bayer Identifier:

15446

ClinicalTrials.gov Identifier:

NCT01408511

EudraCT Number:

Not Available

EU CT 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
black-arrow
Phase
2
Could I receive a placebo?
No
Products
Mapracorat (BAY86-5319)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Locations
Locations

PAREXEL Bloemfontein

Bloemfontein, South Africa

Locations

PAREXEL George

George, South Africa

Locations

PAREXEL Port Elizabeth

Port Elizabeth, South Africa

Trial Design