check_circleStudy 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
  • - 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
  • - 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
23
Trial Dates
July 2011 - December 2011
Phase
Phase 2
Could I Receive a placebo
No
Products
Mapracorat (BAY86-5319)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
PAREXEL BloemfonteinBloemfontein, South Africa
Completed
PAREXEL GeorgeGeorge, South Africa
Completed
PAREXEL Port ElizabethPort Elizabeth, South Africa

Primary Outcome

  • HPA axis response to Cosyntropin: Number of subjects with adrenal suppression
    date_rangeTime Frame:
    measured after 4 weeks of therapy
    enhanced_encryption
    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
1

Additional Information

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