Comparison of Pimecrolimus Cream 1% Twice-Daily to Once-Daily Dosing in the Management of Atopic Dermatitis in Pediatric Subjects
|ClinicalTrials.gov Identifier: NCT00139581|
Recruitment Status : Completed
First Posted : August 31, 2005
Last Update Posted : April 23, 2008
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".
|Condition or disease||Intervention/treatment||Phase|
|Atopic Dermatitis||Drug: Pimecrolimus||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Comparison of Pimecrolimus Cream 1% Twice-Daily to Once-Daily Dosing in the Management of Atopic Dermatitis in Pediatric Subjects|
|Study Start Date :||September 2004|
|Actual 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00139581
|This study is not being conducted in the United States|
|Novartis Pharma AG, Basel, Switzerland|
|Study Chair:||Novartis Pharma AG||Novartis Pharmaceuticals|