Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00432328
Status:
TERMINATED
Last Update Posted:
2009-01-13
First Post:
2007-02-06
Brief Title:
Juvista Avotermin in Breast Reduction Surgery Scars
Sponsor:
Renovo
Organization:
Renovo
Study Overview
Official Title:
A Double Blind Placebo Controlled Randomised Trial to Investigate the Efficacy of Juvista Avotermin in the Improvement of Scar Appearance in Patients Undergoing Bilateral Reduction Mammaplasty
Status:
TERMINATED
Status Verified Date:
2009-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Futility analysis undertaken determined that study was underpowered
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Severe scarring is a common problem following breast reduction surgery studies have shown that over 64 of patients develop a hypertrophic scar at three months after the operation Scar severity can be influenced by a large number of factors including age sex skin thickness and tension ethnicity and the position of the scar on the body Therefore the most sensitive and reliable method to assess the efficacy of an anti-scarring treatment is to compare bilateral wounds on the same individual Bilateral breast reduction surgery provides an ideal model for a within patient evaluation of anti-scarring activity in wounds which develop into bad scars
This study is being undertaken to investigate the efficacy and safety of Juvista given as an intradermal injection of 200ng per 1cm wound margin in the reduction of scar appearance applied to approximated wound margins following bilateral reduction mammaplasty
This study is being undertaken to investigate the efficacy and safety of Juvista given as an intradermal injection of 200ng per 1cm wound margin in the reduction of scar appearance applied to approximated wound margins following bilateral reduction mammaplasty
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