Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00436449
Status:
COMPLETED
Last Update Posted:
2008-08-14
First Post:
2007-02-16
Brief Title:
RN1001Avotermin in Scar Improvement Following Breast Augmentation
Sponsor:
Renovo
Organization:
Renovo
Study Overview
Official Title:
A Double Blind Within Subject Placebo Controlled Randomised Trial to Investigate the Scar Improvement Efficacy of a Single Intradermal Application of RN1001 Avotermin in Female Subjects Undergoing Bilateral Breast Augmentation
Status:
COMPLETED
Status Verified Date:
2008-08
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 will be a multi-centre double-blind within-subject placebo controlled randomised trial in female subjects All subjects will undergo bilateral breast augmentation surgery Immediately following surgery each subject will receive 100µl containing 50ng or 200ng of RN1001 per linear centimetre intradermally into both margins of one breast wound and 100µl of placebo solution per linear centimetre intradermally into both margins of their other breast wound The allocation of treatment to wound left or right will be randomised and double blind
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