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Dose Escalation of Different Concentrations of ZK 245186 in Atopic Dermatitis

Primary Purpose

Atopic Dermatitis

Status

Completed

Phase

Phase 2

Locations

South Africa

Study Type

Interventional

Intervention

ZK 245186

Placebo (vehicle ointment)

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

PAREXEL International (Bloemfontein)
PAREXEL International (George)
PAREXEL International (Port Elizabeth)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Zk 245186 0.01% ointment

ZK 245186 0.03% ointment

ZK 245186 0.1% ointment

Vehicle ointment

Arm Description

Active treatment, lowest dose

Active comparator middle dose

Active comparator highest dose

Placebo comparator

Outcomes

Primary Outcome Measures

Assessment of the severity of atopic dermatitis at target lesion, based on clinical signs of inflammation

Secondary Outcome Measures

Investigator's Global Assessment of target area

Full Information

NCT ID

NCT00944632

First Posted

July 22, 2009

Last Updated

June 5, 2023

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT00944632

Brief Title

Dose Escalation of Different Concentrations of ZK 245186 in Atopic Dermatitis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

July 15, 2009 (Actual)

Primary Completion Date

September 15, 2010 (Actual)

Study Completion Date

September 15, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atopic Dermatitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Zk 245186 0.01% ointment

Arm Type

Active Comparator

Arm Description

Active treatment, lowest dose

Arm Title

ZK 245186 0.03% ointment

Arm Type

Active Comparator

Arm Description

Active comparator middle dose

Arm Title

ZK 245186 0.1% ointment

Arm Type

Active Comparator

Arm Description

Active comparator highest dose

Arm Title

Vehicle ointment

Arm Type

Placebo Comparator

Arm Description

Placebo comparator

Intervention Type

Drug

Intervention Name(s)

ZK 245186

Intervention Description

Once daily topical non-occlusive application for up to 4 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo (vehicle ointment)

Intervention Description

Once daily topical non-occlusive application for up to 4 weeks

Primary Outcome Measure Information:

Title

Assessment of the severity of atopic dermatitis at target lesion, based on clinical signs of inflammation

Time Frame

up to 4 weeks

Secondary Outcome Measure Information:

Title

Investigator's Global Assessment of target area

Time Frame

up to 4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

Facility Name

PAREXEL International (Bloemfontein)

City

Bloemfontein

ZIP/Postal Code

9301

Country

South Africa

Facility Name

PAREXEL International (George)

City

George

ZIP/Postal Code

6529

Country

South Africa

Facility Name

PAREXEL International (Port Elizabeth)

City

Newton Park

ZIP/Postal Code

6045

Country

South Africa

12. IPD Sharing Statement

Learn more about this trial

Dose Escalation of Different Concentrations of ZK 245186 in Atopic Dermatitis

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