HPA Axis Study in Japanese Adults

Phase 2

Completed

• Conditions: Atopic Dermatitis; Eczema
• Interventions: Drug: Mapracorat

• Registration Number: NCT01407510
• Lead Sponsor: Bayer

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2011-05-09
• Study First Submitted: 2011-08-01
• Study First Submitted QC: 2011-08-01
• Study First Posted: 2011-08-02
• Primary Completion: 2011-09-16
• Study Completion: 2012-04-15
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-18
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Mapracorat	-

Primary Outcome Measures

Name	Time	Method
number of subjects with adrenal suppression

Trial Locations

Locations (3)

Kawaguchi Kogyo General Hospital; 🇯🇵 Saitama, Japan

Clinical Research Hospital Tokyo; 🇯🇵 Tokyo, Japan

Tokyo Women's Medical University; 🇯🇵 Tokyo, Japan