HPA Axis Study in Adults
- Registration Number
- NCT01408511
- Lead Sponsor
- Bayer
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 1 Mapracorat -
- Primary Outcome Measures
Name Time Method HPA axis response to Cosyntropin: Number of subjects with adrenal suppression measured after 4 weeks of therapy
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
PAREXEL Port Elizabeth
🇿🇦Port Elizabeth, South Africa
PAREXEL Bloemfontein
🇿🇦Bloemfontein, South Africa
PAREXEL George
🇿🇦George, South Africa