HPA Axis Study in Adults

October 30, 2023 updated by: Bayer

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

23

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

  • South Africa
      • Bloemfontein, South Africa
        • PAREXEL Bloemfontein
      • George, South Africa
        • PAREXEL George
      • Port Elizabeth, South Africa
        • PAREXEL Port Elizabeth

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Signed written informed consent
  • Male or female subject aged >= 18 years
  • Diagnosis of atopic dermatitis according to 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 study conduct or the evaluation and interpretation of the study results
  • 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
Time Frame
HPA axis response to Cosyntropin: Number of subjects with adrenal suppression
Time Frame: measured after 4 weeks of therapy
measured after 4 weeks of therapy

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)

July 19, 2011

Primary Completion (Actual)

December 15, 2011

Study Completion (Actual)

December 21, 2011

Study Registration Dates

First Submitted

August 1, 2011

First Submitted That Met QC Criteria

August 2, 2011

First Posted (Estimated)

August 3, 2011

Study Record Updates

Last Update Posted (Actual)

October 31, 2023

Last Update Submitted That Met QC Criteria

October 30, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15446
  • 1403161 (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.

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