Comparison of Pimecrolimus Cream 1% Twice-Daily to Once-Daily Dosing in the Management of Atopic Dermatitis in Pediatric Subjects
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|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.
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): NCT00139581
|This study is not being conducted in the United States|
|Novartis Pharma AG, Basel, Switzerland|
|Study Chair:||Novartis Pharma AG||Novartis Pharmaceuticals|