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

Atopic Dermatitis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01228513
• Other study ID #: 15267
• Secondary ID: 1403380
• Status: Completed
• Phase: Phase 2
• First received: October 14, 2010
• Last updated: December 17, 2015
• Start date: November 2010
• Est. completion date: April 2012

Study information

• Verified date: December 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 263
• Est. completion date: April 2012
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• ZK245186
Daily topical application
• Placebo (vehicle without active ingredient)
Daily topical application

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eczema Area and Severity Index (EASI)	Eczema area and severity index	At baseline	No
Primary	EASI	Ezcema area and severity index	Measured after one week of treatment	No
Primary	EASI	Eczema area and severity index	Measured at the end of 2 weeks of treatment	No
Primary	EASI	Eczema area and severity index	Measured at the end of 3 weeks of treatment	No
Primary	EASI	Eczema area and severity index	Measured at the end of 4 weeks of treatment	No
Secondary	Subjects' assessment of pruritus	Subjective measurement on a point scale	Measured at baseline	No
Secondary	Subject's assessment of pruritus	Subjective measurement on a point scale	Measured after one week of treatment	No
Secondary	Subject's assessment of pruritus	Subjective measurement on a point scale	Measured after two weeks of treatment	No
Secondary	Subject's assessment of pruritus	Subjective measurement on a point scale	Measured after three weeks of treatment	No
Secondary	Subject's assessment of pruritus	Subjective measurement on a point scale	Measured after four weeks of treatment	No

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