Clinical trial NCT01228513: Efficacy and Safety of Different Concentrations of ZK245186 in Atopic Dermatitis (AD)
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2010-10-26
Enrollment: 263
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Eczema Area and Severity Index (EASI)
timeFrame: At baseline
measure: EASI
timeFrame: Measured after one week of treatment
measure: EASI
timeFrame: Measured at the end of 2 weeks of treatment
measure: EASI
timeFrame: Measured at the end of 3 weeks of treatment
measure: EASI
timeFrame: Measured at the end of 4 weeks of treatment
Secondary outcomes:
measure: Subjects' assessment of pruritus
timeFrame: Measured at baseline
measure: Subject's assessment of pruritus
timeFrame: Measured after one week of treatment
measure: Subject's assessment of pruritus
timeFrame: Measured after two weeks of treatment
measure: Subject's assessment of pruritus
timeFrame: Measured after three weeks of treatment
measure: Subject's assessment of pruritus
timeFrame: Measured after four weeks of treatment
Other outcomes:
Locations:
city: Anaheim
country: United States
state: California
city: Honolulu
country: United States
state: Hawaii
city: Boise
country: United States
state: Idaho
city: Chicago
country: United States
state: Illinois
city: Boston
country: United States
state: Massachusetts
city: Warren
country: United States
state: Michigan
city: Fridley
country: United States
state: Minnesota
city: New York
country: United States
state: New York
city: Portland
country: United States
state: Oregon
city: Austin
country: United States
state: Texas
city: College Station
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Webster
country: United States
state: Texas
city: Kawaguchi Saitama
country: Japan
city: Tokyo
country: Japan
city: Tokyo
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: