Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00124709
Status:
TERMINATED
Last Update Posted:
2011-03-23
First Post:
2005-07-26
Brief Title:
Safety and Efficacy of Pimecrolimus Cream 1 in Atopic Disease Modification
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
An Investigation of the Safety and Efficacy of Elidel 1 Cream in Atopic Disease Modification Assessed in a 3-year Randomized Double-blind Vehicle Controlled Phase to Evaluate Effects on Atopic Dermatitis in Infants and a 2-3 Year Open-label Phase to Evaluate the Effect of Early Intervention Versus Delayed Intervention With Elidel on the Incidence of Asthma in Children
Status:
TERMINATED
Status Verified Date:
2011-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study consists of a 3-year double-blind phase during which patients will receive atopic dermatitis AD treatment either with pimecrolimus cream 1 long-term management LTM or with a conventional corticosteroid-based treatment 11 ratio followed by a 2 to 3-year open-label OL phase all patients receiving pimecrolimus cream 1 LTM At the end of the double-blind phase the two treatment groups will be compared with respect to their efficacy in controlling AD at the end of the OL phase the incidence of asthma at the age of 6 years will be compared
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None