Atopic Dermatitis, Eczema
Conditions
Brief summary
A multicenter, open-label study to evaluate the adrenal suppression potential of Mapracorat 0.1% ointment in adults with atopic dermatitis.
Detailed description
Assessment of safety, efficacy, pharmacokinetics and adrenal suppression potential of Mapracorat 0.1% ointment in adults with atopic dermatitis.
Interventions
DRUGMapracorat
Application of the investigational product on the affected skin areas
Sponsors
Bayer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HPA axis response to Cosyntropin: Number of subjects with adrenal suppression | measured after 4 weeks of therapy |
Countries
South Africa
Outcome results
None listed