Trial Condition(s):
Atopic dermatitis, Eczema
HPA Axis Study in Adults
Bayer Identifier:
15446
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations PAREXEL Bloemfontein Bloemfontein, South Africa | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations PAREXEL George George, South Africa | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations PAREXEL Port Elizabeth Port Elizabeth, South Africa | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A Multicenter, Open Label Study to Evaluate the Adrenal Suppression Potential of Mapracorat 0.1% Ointment in Adults With Atopic Dermatitis
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
N/A
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- HPA axis response to Cosyntropin: Number of subjects with adrenal suppressionTimeframe: measured after 4 weeks of therapy
Additional Information
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