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Completed

NCT Number: NCT01228513

Efficacy and Safety of Different Concentrations of ZK245186 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 placebo in the treatment of atopic dermatitis.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic 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–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kawaguchi Saitama, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of atopic dermatitis according to Hanifin and Rajka criteria
  • Body surface area affected by atopic dermatitis at or less than 15% at start of treatment

Exclusion criteria

  • Pregnancy and breast-feeding
  • Conditions that may pose a threat to the patient or effect the outcome of the study
  • Wide-spread atopic dermatitis (AD) requiring systemic treatment
  • Immuno-compromized conditions
  • At least 2 weeks after local AD treatment and treatment with systemic antibiotics
  • At least 1 month after systemic AD treatment

Treatment and study plan

ZK245186

Drug

Daily topical application

Other names: Mapracorat (BAY86-5319)

Placebo (vehicle without active ingredient)

Drug

Daily topical application

Primary outcomes

  1. Eczema Area and Severity Index (EASI)

    Time frame: At baseline

    Eczema area and severity index

  2. EASI

    Time frame: Measured after one week of treatment

    Ezcema area and severity index

  3. EASI

    Time frame: Measured at the end of 2 weeks of treatment

    Eczema area and severity index

  4. EASI

    Time frame: Measured at the end of 3 weeks of treatment

    Eczema area and severity index

  5. EASI

    Time frame: Measured at the end of 4 weeks of treatment

    Eczema area and severity index

Secondary outcomes

  1. Subjects' assessment of pruritus

    Time frame: Measured at baseline

    Subjective measurement on a point scale

  2. Subject's assessment of pruritus

    Time frame: Measured after one week of treatment

    Subjective measurement on a point scale

  3. Subject's assessment of pruritus

    Time frame: Measured after two weeks of treatment

    Subjective measurement on a point scale

  4. Subject's assessment of pruritus

    Time frame: Measured after three weeks of treatment

    Subjective measurement on a point scale

  5. Subject's assessment of pruritus

    Time frame: Measured after four weeks of treatment

    Subjective measurement on a point scale

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 ZK245186 Ointment in Concentrations of 0.01, 0.03, and 0.1% Over 4 Weeks in Patients With Atopic Dermatitis (AD)

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Oct 26, 2010
Registry last updated
Jan 21, 2016

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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