Study Completed

Atopic Dermatitis, Eczema

Bayer Identifier:

15446

ClinicalTrials.gov Identifier:

NCT01408511

EudraCT Number:

Not Available

EU CT Number:

Not Available

HPA Axis Study in Adults

Trial purpose

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

Key Participants Requirements

Sex

Both

Age

18 - N/A

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

Trial summary

Enrollment Goal

Trial Dates

July 2011 - December 2011

Phase

Phase 2

Could I Receive a placebo

Products

Mapracorat (BAY86-5319)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	PAREXEL Bloemfontein	Bloemfontein, South Africa
Completed	PAREXEL George	George, South Africa
Completed	PAREXEL Port Elizabeth	Port Elizabeth, South Africa

Primary Outcome

HPA axis response to Cosyntropin: Number of subjects with adrenal suppression
Time Frame:
measured after 4 weeks of therapy
Safety Issue:
Yes

Trial design

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

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

N/A

Blinding

Open Label

Assignment

Single Group Assignment

Trial Arms

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer Healthcare products.