A Quality of Life and Safety Study With Pimecrolimus Cream, 1% in Children (Age 2-12 Years) With Atopic Dermatitis
|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: NCT00484003|
Recruitment Status : Completed
First Posted : June 8, 2007
Last Update Posted : February 15, 2008
|Condition or disease||Intervention/treatment||Phase|
|Atopic Eczema||Drug: Pimecrolimus cream 1%||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A 3-Month Open Label, National, Quality of Life , and Safety Study With Pimecrolimus Cream, 1% in Children (Age 2-12 Years ) With Atopic Dermatitis|
|Study Start Date :||October 2004|
|Study Completion Date :||December 2004|
Drug: Pimecrolimus cream 1%
- Quality of Life assessment on scheduled visits at Day 1 (Baseline), Day 14 and Day 90 or day of early discontinuation visit.
- Safety data will be collected by monitoring and recording all adverse events (AEs)and Serious Adverse Events(SAEs) throughout the duration of the trial.
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): NCT00484003
|Various Cities, South Africa|
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|