Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00368719
Status:
WITHDRAWN
Last Update Posted:
2015-04-07
First Post:
2006-08-24
Brief Title:
Evaluation to Assess the Long Term Safety of Tacrolimus Ointment for Atopic Dermatitis
Sponsor:
University of California Davis
Organization:
University of California Davis
Study Overview
Official Title:
APPLES A Prospective Pediatric Longitudinal Evaluation To Assess The Long Term Safety Of Tacrolimus Ointment For The Treatment Of Atopic Dermatitis
Status:
WITHDRAWN
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
withdrawn due to contractual issues
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To assess the long-term safety of tacrolimus ointment
Detailed Description:
To assess the long-term safety of tacrolimus ointment 003 or 01 in the treatment of subjects with atopic dermatitis under actual use conditions including the risk of developing cutaneous or systemic malignancies The FDA and EMEA approved Tacrolimus ointment 003 in children and 01 and 003 in adults for the treatment of atopic dermatitis As part of the approval process the FDA and EMEA requested a post-marketing commitment regarding the safety of long-term use of Tacrolimus ointment in pediatric atopic dermatitis subjects
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