|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
20 June 2023 |
|
Main ID: |
NCT00944632 |
|
Date of registration:
|
22/07/2009 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Dose Escalation of Different Concentrations of ZK 245186 in Atopic Dermatitis
|
|
Scientific 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 |
|
Date of first enrolment:
|
July 15, 2009 |
|
Target sample size:
|
64 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT00944632 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
Germany
|
South Africa
| | | | | | |
|
Contacts
|
|
Name:
|
Bayer Study Director |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Bayer |
| | |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Atopic Dermatitis
|
|
Intervention(s)
|
|
Drug: ZK 245186
|
|
Drug: Placebo (vehicle ointment)
|
|
Primary Outcome(s)
|
|
Assessment of the severity of atopic dermatitis at target lesion, based on clinical signs of inflammation
[Time Frame: up to 4 weeks]
|
|
Secondary Outcome(s)
|
|
Investigator's Global Assessment of target area
[Time Frame: up to 4 weeks]
|
|
Secondary ID(s)
|
|
14501
|
|
1402942
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|