Trial Condition(s):
Atopic dermatitis, Eczema
HPA axis study in Japanese adults
Bayer Identifier:
15519
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 Japanese adults with atopic dermatitis.
Inclusion Criteria
- Signed written informed consent - Male or female subject aged >= 20 years - Diagnosis of atopic dermatitis according to the 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 investigator's ability to evaluate the subject's response to the investigational product - 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 Kawaguchi Kogyo General Hospital Saitama, Japan | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Research Hospital Tokyo Tokyo, Japan | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tokyo Women's Medical University Tokyo, Japan | 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 Japanese 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
- number of subjects with adrenal suppressionTimeframe:
Additional Information
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