HPA Axis Study in Japanese Adults

NCT ID: NCT01407510

Last Updated: 2023-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-09

Study Completion Date

2012-04-15

Brief Summary

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

Detailed Description

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

Conditions

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Atopic Dermatitis Eczema

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Mapracorat

Intervention Type DRUG

Application of the investigational product on the affected skin areas

Interventions

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Mapracorat

Application of the investigational product on the affected skin areas

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Kawaguchi Kogyo General Hospital

Saitama, , Japan

Site Status

Clinical Research Hospital Tokyo

Tokyo, , Japan

Site Status

Tokyo Women's Medical University

Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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1403460

Identifier Type: OTHER

Identifier Source: secondary_id

15519

Identifier Type: -

Identifier Source: org_study_id

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