check_circleStudy 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
  • - 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
  • - 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
July 2009 - September 2010
Phase
Phase 2
Could I Receive a placebo
Yes
Products
Mapracorat (BAY86-5319)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
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
    date_rangeTime Frame:
    up to 4 weeks
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Investigator's Global Assessment of target area
    date_rangeTime Frame:
    up to 4 weeks
    enhanced_encryption
    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
4

Additional Information

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