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NCT00944632 Clinical Trial

Dose Escalation of Different Concentrations of ZK 245186 in Atopic Dermatitis

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00944632
Other study ID # 14501
Secondary ID 1402942
Status Completed
Phase Phase 2
First received
Last updated
Start date July 15, 2009
Est. completion date September 15, 2010

Study information
Verified date June 2023
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 64
Est. completion date September 15, 2010
Est. primary completion date September 15, 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• ZK 245186
Once daily topical non-occlusive application for up to 4 weeks
• Placebo (vehicle ointment)
Once daily topical non-occlusive application for up to 4 weeks

Locations
Country Name City State
South Africa PAREXEL International (Bloemfontein) Bloemfontein
South Africa PAREXEL International (George) George
South Africa PAREXEL International (Port Elizabeth) Newton Park

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

South Africa, 

Outcome
Type Measure Description Time frame Safety issue
Primary Assessment of the severity of atopic dermatitis at target lesion, based on clinical signs of inflammation up to 4 weeks
Secondary Investigator's Global Assessment of target area up to 4 weeks
See also
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