check_circleStudy Completed

Atopic Dermatitis, Eczema

Bayer Identifier:

15519

ClinicalTrials.gov Identifier:

NCT01407510

EudraCT Number:

Not Available

EU CT Number:

Not Available
HPA axis study in Japanese adults

Trial purpose

A multicenter, open-label study to evaluate the adrenal suppression potential of Mapracorat 0.1% ointment in Japanese adults with atopic dermatitis.

Key Participants Requirements

Sex

Both

Age

20 - N/A
  • - 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
  • - 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
12
Trial Dates
May 2011 - April 2012
Phase
Phase 2
Could I Receive a placebo
No
Products
Mapracorat (BAY86-5319)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Kawaguchi Kogyo General HospitalSaitama, Japan
Completed
Clinical Research Hospital TokyoTokyo, Japan
Terminated
Tokyo Women's Medical UniversityTokyo, Japan

Primary Outcome

  • number of subjects with adrenal suppression
    enhanced_encryption
    Safety Issue:
    Yes

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

Additional Information

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