A Quality of Life and Safety Study With Pimecrolimus Cream, 1% in Children (Age 2-12 Years) With Atopic Dermatitis
This study has been completed.
Information provided by:
First received: June 7, 2007
Last updated: February 13, 2008
Last verified: February 2008
The study will evaluate the safety and effect of pimecrolimus cream 1% on quality of life of caregivers of South African children with mild to moderate atopic dermatitis (AD).
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Quality of Life assessment on scheduled visits at Day 1 (Baseline), Day 14 and Day 90 or day of early discontinuation visit.
Secondary Outcome Measures:
- Safety data will be collected by monitoring and recording all adverse events (AEs)and Serious Adverse Events(SAEs) throughout the duration of the trial.
|Study Start Date:||October 2004|
|Study Completion Date:||December 2004|
Drug: Pimecrolimus cream 1%
Other Name: Elidel
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