Quality of Life Study in Adults With Facial Eczema
This study is not being conducted in the US.
The study consists of a 4 week double blind treatment period. All patients meeting the inclusion/exclusion criteria will enter the study at day 0 and be randomized into either pimecrolimus cream 1% or vehicle treatment groups in a 1:1 ratio. Patients will return to clinic on days 7,14 and 28 for assessments of disease severity. Patients who experience an unsatisfactory therapeutic effect, will attend an unscheduled visit and be withdrawn from the study.
Assessments of eligibility include an Investigator's Global Assessment and Pruritus score. Treatment history will be collected at baseline and Quality of Life Questionnaires will be carried out at every visit.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Quality of Life Study in Adults With Facial Eczema|
- Change in quality of life score between baseline (study start) and week 4.
- Changes in patient's quality of life from baseline (study start) to 1 and 2 weeks after the beginning of treatment.
- Between-treatment comparison of Investigator's Global Assessment (IGA) (face only); Patient's Global Assessment (face only); Pruritus (itch) Severity Assessment (face only).
- Time from baseline (study start) to clearance of eczema.
|Study Start Date:||March 2005|
|Study Completion Date:||January 2006|
Pimecrolimus cream 1 %
Other Name: Elidel
Placebo Comparator: 2
Matching vehicle cream
Please refer to this study by its ClinicalTrials.gov identifier: NCT00120302
|This study is not being conducted in the United States|
|Novartis Pharmaceuticals UK, Frimley, United Kingdom|