HPA Axis Study in Adults

Bayer23 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Atopic Dermatitis Eczema

Interventions

MapracoratDRUG

Application of the investigational product on the affected skin areas

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

PAREXEL Bloemfontein

Bloemfontein, South Africa

PAREXEL George

George, South Africa

PAREXEL Port Elizabeth

Port Elizabeth, South Africa

Outcomes

Primary Outcomes

HPA axis response to Cosyntropin: Number of subjects with adrenal suppression

Time frame: measured after 4 weeks of therapy

Data from ClinicalTrials.gov

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