Dose Escalation of Different Concentrations of ZK 245186 in Atopic Dermatitis

Double-blind, Randomized, Dose Escalation Study of the Efficacy and Safety of ZK 245186 Ointment in Concentrations of 0.01%, 0.03%, and 0.1% Over 4 Weeks in Patients With Atopic Dermatitis

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.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: ZK 245186; Drug: Placebo (vehicle ointment)

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 2

Contacts and Locations

Study Locations

• South Africa
  • Bloemfontein, South Africa, 9301
    • PAREXEL International (Bloemfontein)
  • George, South Africa, 6529
    • PAREXEL International (George)
  • Newton Park, South Africa, 6045
    • PAREXEL International (Port Elizabeth)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Zk 245186 0.01% ointment; Active treatment, lowest dose	Drug: ZK 245186; Once daily topical non-occlusive application for up to 4 weeks
Active Comparator: ZK 245186 0.03% ointment; Active comparator middle dose	Drug: ZK 245186; Once daily topical non-occlusive application for up to 4 weeks
Active Comparator: ZK 245186 0.1% ointment; Active comparator highest dose	Drug: ZK 245186; Once daily topical non-occlusive application for up to 4 weeks
Placebo Comparator: Vehicle ointment; Placebo comparator	Drug: Placebo (vehicle ointment); Once daily topical non-occlusive application for up to 4 weeks

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Investigator's Global Assessment of target area	up to 4 weeks

Collaborators and Investigators

• Sponsor: Bayer
• Investigators: Study Director: Bayer Study Director, Bayer

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2009
• Primary Completion (Actual): September 15, 2010
• Study Completion (Actual): September 15, 2010

Study Registration Dates

• First Submitted: July 22, 2009
• First Submitted That Met QC Criteria: July 22, 2009
• First Posted (Estimated): July 23, 2009

Study Record Updates

• Last Update Posted (Actual): June 7, 2023
• Last Update Submitted That Met QC Criteria: June 5, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: 14501; 1402942 (Other Identifier: Company internal)