HPA Axis Study in Adults

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01408511
• Collaborator: (none)
• Enrollment: 23
• Locations: 3
• Arm: 1
• Duration (Months): 5
• Patients Per Site: 7.7
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

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

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

Detailed Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 23 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 Adults With Atopic Dermatitis
• Study Start Date: Jul 1, 2011
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Dec 1, 2011

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. HPA axis response to Cosyntropin: Number of subjects with adrenal suppression [measured after 4 weeks of therapy]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Bloemfontein		South Africa
2		George		South Africa
3		Port Elizabeth		South Africa

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: NCT01408511
• Other Study ID Numbers: 15446; 1403161
• First Posted: Aug 3, 2011
• Last Update Posted: Mar 20, 2015
• Last Verified: Mar 1, 2015

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

Study Results

No Results Posted as of Mar 20, 2015