HPA Axis Study in Adults (NCT01408511) | Clinical Trial Compass
CompletedPhase 2
HPA Axis Study in Adults
South Africa23 participantsStarted 2011-07-19
Plain-language summary
A multicenter, open-label study to evaluate the adrenal suppression potential of Mapracorat 0.1% ointment in adults with atopic dermatitis.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
HPA axis response to Cosyntropin: Number of subjects with adrenal suppression