Status:
COMPLETED
HPA Axis Study in Adults
Lead Sponsor:
Bayer
Conditions:
Atopic Dermatitis
Eczema
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 19 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2011
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT01408511
Start Date
July 19 2011
End Date
December 21 2011
Last Update
October 31 2023
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
PAREXEL Bloemfontein
Bloemfontein, South Africa
2
PAREXEL George
George, South Africa
3
PAREXEL Port Elizabeth
Port Elizabeth, South Africa