HPA Axis Study in Japanese Adults

Bayer12 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Atopic Dermatitis Eczema

Interventions

MapracoratDRUG

Application of the investigational product on the affected skin areas

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (3)

Kawaguchi Kogyo General Hospital

Saitama, Japan

Clinical Research Hospital Tokyo

Tokyo, Japan

Tokyo Women's Medical University

Tokyo, Japan

Outcomes

Primary Outcomes

number of subjects with adrenal suppression

Data from ClinicalTrials.gov

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