Efficacy and Safety of Different Concentrations of ZK245186 in Atopic Dermatitis (AD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01228513
First received: October 14, 2010
Last updated: February 19, 2014
Last verified: February 2014

October 14, 2010
February 19, 2014
November 2010
July 2011   (final data collection date for primary outcome measure)
  • Eczema Area and Severity Index (EASI) [ Time Frame: At baseline ] [ Designated as safety issue: No ]
    Eczema area and severity index
  • EASI [ Time Frame: Measured after one week of treatment ] [ Designated as safety issue: No ]
    Ezcema area and severity index
  • EASI [ Time Frame: Measured at the end of 2 weeks of treatment ] [ Designated as safety issue: No ]
    Eczema area and severity index
  • EASI [ Time Frame: Measured at the end of 3 weeks of treatment ] [ Designated as safety issue: No ]
    Eczema area and severity index
  • EASI [ Time Frame: Measured at the end of 4 weeks of treatment ] [ Designated as safety issue: No ]
    Eczema area and severity index
Same as current
Complete list of historical versions of study NCT01228513 on ClinicalTrials.gov Archive Site
  • Subjects' assessment of pruritus [ Time Frame: Measured at baseline ] [ Designated as safety issue: No ]
    Subjective measurement on a point scale
  • Subject's assessment of pruritus [ Time Frame: Measured after one week of treatment ] [ Designated as safety issue: No ]
    Subjective measurement on a point scale
  • Subject's assessment of pruritus [ Time Frame: Measured after two weeks of treatment ] [ Designated as safety issue: No ]
    Subjective measurement on a point scale
  • Subject's assessment of pruritus [ Time Frame: Measured after three weeks of treatment ] [ Designated as safety issue: No ]
    Subjective measurement on a point scale
  • Subject's assessment of pruritus [ Time Frame: Measured after four weeks of treatment ] [ Designated as safety issue: No ]
    Subjective measurement on a point scale
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Different Concentrations of ZK245186 in Atopic Dermatitis (AD)
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)

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Atopic Dermatitis
  • Drug: ZK245186
    Daily topical application
  • Drug: Placebo (vehicle without active ingredient)
    Daily topical application
  • Active Comparator: 0.01% ointment
    Lowest concentration
    Intervention: Drug: ZK245186
  • Active Comparator: 0.03% ointment
    Middle concentration
    Intervention: Drug: ZK245186
  • Active Comparator: 0.1% ointment
    Highest concentration
    Intervention: Drug: ZK245186
  • Placebo Comparator: Placebo (vehicle without active)
    No active ingredient
    Intervention: Drug: Placebo (vehicle without active ingredient)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
263
April 2012
July 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Japan
 
NCT01228513
15267, 1403380
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP