HPA Axis Study in Japanese Adults

Bayer

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis; Eczema

Treatments: Drug: Mapracorat

Study type: Interventional

Funder types: Industry

Identifiers

NCT01407510

15519

1403460 (Other Identifier)

Details and patient eligibility

About

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

Full description

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

Enrollment: 12 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Arm 1

Experimental group

Treatment:

Drug: Mapracorat