Dose Escalation of Different Concentrations of ZK 245186 in Atopic Dermatitis

Phase 2

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: ZK 245186; Drug: Placebo (vehicle ointment)

• Registration Number: NCT00944632
• Lead Sponsor: Bayer

Brief Summary

The purpose of this study is to determine the safety and efficacy of three concentrations of ZK 245186 ointment and vehicle on increasing body surface areas for the treatment of atopic dermatitis and to obtain dose-response information for the three concentrations.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-07-15
• Study First Submitted: 2009-07-22
• Study First Submitted QC: 2009-07-22
• Study First Posted: 2009-07-23
• Primary Completion: 2010-09-15
• Study Completion: 2010-09-15
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-05
• Last Update Posted: 2023-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• diagnosis of atopic dermatitis (Hanifin and Rajka criteria)
• mild to moderate atopic dermatitis at beginning of study
• wash-out periods for systemic and topical treatments for atopic dermatitis
• females must use effective contraception

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Exclusion Criteria

• pregnant or lactating women
• conditions that in the opinion of the investigator may pose a risk or interfere with the evaluation of the study
• wide-spread atopic dermatitis requiring systemic treatment
• diagnosed with immunocompromised status
• skin diseases - other than atopic dermatitis - in the treatment area
• mental handicap or legally incompetent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zk 245186 0.01% ointment	ZK 245186	Active treatment, lowest dose
ZK 245186 0.1% ointment	ZK 245186	Active comparator highest dose
ZK 245186 0.03% ointment	ZK 245186	Active comparator middle dose
Vehicle ointment	Placebo (vehicle ointment)	Placebo comparator

Primary Outcome Measures

Name	Time	Method
Assessment of the severity of atopic dermatitis at target lesion, based on clinical signs of inflammation	up to 4 weeks

Secondary Outcome Measures

Name	Time	Method
Investigator's Global Assessment of target area	up to 4 weeks

Trial Locations

Locations (3)

PAREXEL International (Bloemfontein); 🇿🇦 Bloemfontein, South Africa

PAREXEL International (George); 🇿🇦 George, South Africa

PAREXEL International (Port Elizabeth); 🇿🇦 Newton Park, South Africa