Comparison of Pimecrolimus Cream 1% Twice-Daily to Once-Daily Dosing in the Management of Atopic Dermatitis in Pediatric Subjects
This study is not being conducted in the United States.
To investigate the relative efficacy of pimecrolimus cream 1% applied twice daily (b.i.d.) versus once daily (o.d.) in preventing the progression to disease "relapse".
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Comparison of Pimecrolimus Cream 1% Twice-Daily to Once-Daily Dosing in the Management of Atopic Dermatitis in Pediatric Subjects|
- Time to relapse of atopic dermatitis (defined as the exacerbation of atopic dermatitis to the level where a topical corticosteroid or alternative therapy is required).
- Investigators Global Assessment (IGA) and pruritus (itch) assessment of atopic dermatitis at time of suspected relapse
- Time to first recurrence of atopic dermatitis
- Eczema Area and Severity Index (EASI) and IGA assessments at several time points.
|Study Start Date:||September 2004|
|Study Completion Date:||September 2005|
Pimecrolimus cream 1 % applied twice daily (b.i.d.)
Other Name: Elidel b.i.d.
Pimecrolimus o.d. and placebo o.d.
Pimecrolimus cream 1 % applied once daily (o.d.) and placebo applied once daily (o.d.)
Other Name: Elidel o.d.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00139581
|This study is not being conducted in the United States|
|Novartis Pharma AG, Basel, Switzerland|
|Study Chair:||Novartis Pharma AG||Novartis Pharmaceuticals|