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Completed

NCT Number: NCT01359787

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

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).

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Eczema Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Berlin, 10589, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mapracorat

Drug

Daily topical application

Vehicle without active

Drug

Daily topical application

Primary outcomes

  1. Eczema Area and Severity Index (EASI)

    Time frame: Over all study visits for up to 4 weeks

Secondary outcomes

  1. Subjects´ assessment of pruritus

    Time frame: At baseline and after 4 weeks of treatment

    Subjects´ assessment of pruritus using a visual analog scale (VAS)

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Double-blind, Randomized, Vehicle-controlled, Multicenter, Multinational, Parallel-group Study of the Efficacy and Safety of Mapracorat Ointment in Three Concentrations Over Max. 4 Weeks in Subjects With Atopic Dermatitis (AD)

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
May 25, 2011
Registry last updated
Jan 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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