Quality of Life Study in Adults With Facial Eczema
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00120302|
Recruitment Status : Completed
First Posted : July 15, 2005
Last Update Posted : January 17, 2008
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 Patients who experience an unsatisfactory therapeutic effect, will attend an unscheduled visit and be withdrawn from the study.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.
|Condition or disease||Intervention/treatment||Phase|
|Atopic Dermatitis||Drug: Pimecrolimus Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||76 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Quality of Life Study in Adults With Facial Eczema|
|Study Start Date :||March 2005|
|Study Completion Date :||January 2006|
Pimecrolimus cream 1 %
Other Name: Elidel
Placebo Comparator: 2
Matching vehicle cream
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00120302
|This study is not being conducted in the United States|
|Novartis Pharmaceuticals UK, Frimley, United Kingdom|