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NCT01407510 Clinical Trial

HPA Axis Study in Japanese Adults

Atopic Dermatitis Clinical Trial

Official title:
A Multicenter, Open-label Study to Evaluate the Adrenal Suppression Potential of Mapracorat 0.1% Ointment in Japanese Adults With Atopic Dermatitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01407510
Other study ID # 15519
Secondary ID 1403460
Status Completed
Phase Phase 2
First received
Last updated
Start date May 9, 2011
Est. completion date April 15, 2012

Study information
Verified date September 2023
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

Assessment of the adrenal suppression potential, safety, efficacy and pharmacokinetics of Mapracorat 0.1% ointment in Japanese adults with atopic dermatitis.

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date April 15, 2012
Est. primary completion date September 16, 2011
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Mapracorat
Application of the investigational product on the affected skin areas

Locations
Country Name City State
Japan Kawaguchi Kogyo General Hospital Saitama
Japan Clinical Research Hospital Tokyo Tokyo
Japan Tokyo Women's Medical University Tokyo

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary number of subjects with adrenal suppression
See also
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