Efficacy and Safety of Different Concentrations of Mapracorat Ointment Over 4 Weeks in Atopic Dermatitis (AD)

Bayer

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis; Eczema

Treatments: Drug: Vehicle without active; Drug: Mapracorat

Study type: Interventional

Funder types: Industry

Identifiers

NCT01359787

2010-024279-14 (EudraCT Number)

15616

1403440 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of three concentrations of a development drug compared to ointment base (vehicle) in subjects with Atopic Dermatitis (AD).

Enrollment: 197 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed written informed consent
• Diagnosis of atopic dermatitis according to Hanifin and Rajka Criteria
• Willingness of subject to follow all study procedures
• Willingness to avoid excessive exposure of diseased areas to natural or artificial sunlight

Exclusion criteria

• Pregnancy and breast-feeding
• Clinically relevant disease, which could interfere with the study conduct or the evaluation and interpretation of the study results
• Clinically manifested immunosuppressive disorder or known history of malignant disease
• History of relevant drug and/or food allergies

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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197 participants in 4 patient groups, including a placebo group

Mapracorat 0.01% Ointment

Active Comparator group

Description:

Lowest concentration

Treatment:

Drug: Mapracorat

Mapracorat 0.03% Ointment

Active Comparator group

Description:

Middle concentration

Treatment:

Drug: Mapracorat

Mapracorat 0.1% Ointment

Active Comparator group

Description:

Highest concentration

Treatment:

Drug: Mapracorat

Vehicle without active

Placebo Comparator group

Treatment:

Drug: Vehicle without active