Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2026-01-03 @ 12:14 AM
Study NCT ID:
NCT01029158
Status:
COMPLETED
Last Update Posted:
2010-12-09
First Post:
2009-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial to Compare the Efficacy of Two Formulations of Avotermin Against Placebo
Sponsor:
Renovo
Organization:
Study Overview
Official Title:
A Double-blind, Placebo Controlled, Randomised Trial to Compare the Efficacy of 250ng and 500ng RN1006 (a New Formulation of Avotermin) and 250ng and 500ng Juvista (Standard Avotermin Formulation), in the Improvement of Scar Appearance in Healthy Volunteer Subjects
Status:
COMPLETED
Status Verified Date:
2010-12
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:
RN1006
Brief Summary:
RN1006 has been developed as a stabilized formulation of avotermin which, when dosed once in pre-clinical studies in animals, has shown comparable scar improvement efficacy to the standard twice-dosed Juvista formulation. The aim of this trial is to investigate the efficacy of RN1006 compared to Juvista in a human volunteer model
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?: