HPA Axis Study in Japanese Adults

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01407510
• Collaborator: (none)
• Enrollment: 12
• Locations: 2
• Arm: 1
• Duration (Months): 11
• Patients Per Site: 6
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Atopic Dermatitis; Eczema	Drug: Mapracorat	Phase 2

Detailed Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Open-label Study to Evaluate the Adrenal Suppression Potential of Mapracorat 0.1% Ointment in Japanese Adults With Atopic Dermatitis
• Study Start Date: May 1, 2011
• Actual Primary Completion Date: Sep 1, 2011
• Actual Study Completion Date: Apr 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. number of subjects with adrenal suppression []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Saitama		Japan
2		Tokyo		Japan

Sponsors and Collaborators

• Bayer

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT01407510
• Other Study ID Numbers: 15519; 1403460
• First Posted: Aug 2, 2011
• Last Update Posted: Feb 18, 2015
• Last Verified: Feb 1, 2015

• Additional relevant MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema

Study Results

No Results Posted as of Feb 18, 2015