Trial Condition(s):

Atopic dermatitis

Dose Escalation of Different Concentrations of ZK 245186 in Atopic Dermatitis

Bayer Identifier:

14501

ClinicalTrials.gov Identifier:

NCT00944632

EudraCT Number:

Not Available

EU CT Number:

Not Available

Study Completed

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.

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
64
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
Yes
Products
Mapracorat (BAY86-5319)
Accepts Healthy Volunteers
No

Where to Participate

Loading...
Locations
Status
LocationsStatus
Locations

PAREXEL International (Bloemfontein)

Bloemfontein, South Africa, 9301

Status
Completed
Locations

PAREXEL International (George)

George, South Africa, 6529

Status
Completed
Locations

PAREXEL International (Port Elizabeth)

Newton Park, South Africa, 6045

Status
Completed
Locations

Investigative Site

Many locations, South Africa

Status
Not yet recruiting

Trial Design