HPA Axis Study in Japanese Adults

September 18, 2023 updated by: Bayer

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Saitama, Japan
        • Kawaguchi Kogyo General Hospital
      • Tokyo, Japan
        • Tokyo Women's Medical University
      • Tokyo, Japan
        • Clinical Research Hospital Tokyo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Drug: Mapracorat
Application of the investigational product on the affected skin areas

What is the study measuring?

Primary Outcome Measures

Outcome Measure
number of subjects with adrenal suppression

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Investigators

  • Study Director: Bayer Study Director, Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 9, 2011

Primary Completion (Actual)

September 16, 2011

Study Completion (Actual)

April 15, 2012

Study Registration Dates

First Submitted

August 1, 2011

First Submitted That Met QC Criteria

August 1, 2011

First Posted (Estimated)

August 2, 2011

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 18, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15519
  • 1403460 (Other Identifier: Company Internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Eczema

Clinical Trials on Mapracorat

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Serbia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe