Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00475605
Status:
TERMINATED
Last Update Posted:
2019-12-18
First Post:
2007-05-17
Brief Title:
A Pediatric Longitudinal Evaluation to Assess the Long-Term Safety of Protopic for the Treatment of Atopic Dermatitis
Sponsor:
LEO Pharma
Organization:
LEO Pharma
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:
TERMINATED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated early endorsed by the FDA based on futility of continuation
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
APPLES
Brief Summary:
This is an observational study to assess the long-term safety of Protopic Ointment for the treatment of atopic dermatitis Patients whose ages arewere 16 years at the time of first tacrolimus ointment exposure are eligible to participate No drug is distributed during this observational trial
Detailed Description:
Data will be collected at enrollment and every 6 months thereafter either by interview Internet or physician office visit Each subject will be followed for 10 years in this study
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| LP0156-1294 | OTHER | Sponsor LEO Pharma AS | None |
| FG506-06-37 | OTHER | None | None |
| 03-0-161 | OTHER | None | None |
| EUPAS | REGISTRY | None | None |