Efficacy and Safety of Different Concentrations of ZK2451... | NCT01228513

ID	Type	Description	Link
1403380	Other Identifier	Company Internal

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)

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
0.01% ointment	Active Comparator	Lowest concentration	Drug: ZK245186
0.03% ointment	Active Comparator	Middle concentration	Drug: ZK245186
0.1% ointment	Active Comparator	Highest concentration	Drug: ZK245186
Placebo (vehicle without active)	Placebo Comparator	No active ingredient	Drug: Placebo (vehicle without active ingredient)

Name	Type	Description	Arm Group Labels	Other Names
ZK245186	Drug	Daily topical application	0.01% ointment 0.03% ointment 0.1% ointment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Eczema Area and Severity Index (EASI)	Eczema area and severity index	At baseline
EASI	Ezcema area and severity index	Measured after one week of treatment
EASI	Eczema area and severity index	Measured at the end of 2 weeks of treatment
EASI	Eczema area and severity index	Measured at the end of 3 weeks of treatment
EASI	Eczema area and severity index	Measured at the end of 4 weeks of treatment

Secondary Outcomes

Measure	Description	Time Frame
Subjects' assessment of pruritus	Subjective measurement on a point scale	Measured at baseline
Subject's assessment of pruritus	Subjective measurement on a point scale

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Anaheim	California	92801	United States

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

ID	Term
D003876	Dermatitis, Atopic

Ancestor Terms

ID	Term
D012873	Skin Diseases, Genetic
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D003872	Dermatitis
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D017443	Skin Diseases, Eczematous
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases