Study Completed

Atopic Dermatitis

Bayer Identifier:

14501

ClinicalTrials.gov Identifier:

NCT00944632

EudraCT Number:

Not Available

EU CT Number:

Not Available

Dose Escalation of Different Concentrations of ZK 245186 in Atopic Dermatitis

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - 55 Years

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

Trial summary

Enrollment Goal

Trial Dates

July 2009 - September 2010

Phase

Phase 2

Could I Receive a placebo

Yes

Products

Mapracorat (BAY86-5319)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	PAREXEL International (Bloemfontein)	Bloemfontein, 9301, South Africa
Completed	PAREXEL International (George)	George, 6529, South Africa
Completed	PAREXEL International (Port Elizabeth)	Newton Park, 6045, South Africa

Primary Outcome

Assessment of the severity of atopic dermatitis at target lesion, based on clinical signs of inflammation
Time Frame:
up to 4 weeks
Safety Issue:
No

Secondary Outcome

Investigator's Global Assessment of target area
Time Frame:
up to 4 weeks
Safety Issue:
No

Trial design

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

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Randomized

Blinding

Double Blind

Assignment

Parallel Assignment

Trial Arms

Additional Information

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