Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00014729
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2001-04-10
Brief Title:
Phase I Study of Isotretinoin in Patients With Recessive Dystrophic Epidermolysis Bullosa
Sponsor:
University of North Carolina
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2001-05
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:
OBJECTIVES
I Determine the safety of isotretinoin in patients with recessive dystrophic epidermolysis bullosa
I Determine the safety of isotretinoin in patients with recessive dystrophic epidermolysis bullosa
Detailed Description:
PROTOCOL OUTLINE
Patients receive oral isotretinoin daily for 8 months in the absence of disease progression or unacceptable toxicity
Completion date provided represents the completion date of the grant per OOPD records
Patients receive oral isotretinoin daily for 8 months in the absence of disease progression or unacceptable toxicity
Completion date provided represents the completion date of the grant per OOPD records
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UNCCH-FDR001796 | None | None | None |