Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2026-01-02 @ 10:55 AM
Study NCT ID:
NCT00469235
Status:
COMPLETED
Last Update Posted:
2009-09-16
First Post:
2007-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of Juvista (Avotermin) Following Removal of Ear Lobe Keloid Scars
Sponsor:
Renovo
Organization:
Study Overview
Official Title:
A Single-centre, Double Blind, Randomised, Rising Dose Tolerance Study to Investigate the Safety of Juvista When Administered Following Excision of Ear Lobe Keloids.
Status:
COMPLETED
Status Verified Date:
2009-09
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 trial will assess the safety and efficacy of 50 and 200ng Juvista per linear cm of wound margin administered by intradermal injection following the excision of keloid scars on the ear lobe. Ear lobe keloids commonly occur after ear piercing and can be particularly distressing for patients as they are very difficult to conceal and are usually bilateral. As the recurrence rate and growth rate of keloids can vary significantly between individuals, trial subjects will have bilateral ear lobe keloids and will act as their own control. One ear lobe will be treated with Juvista following keloid excision and one with placebo.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: