Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2026-02-24 @ 1:16 AM
Study NCT ID:
NCT00977951
Status:
COMPLETED
Last Update Posted:
2009-09-16
First Post:
2009-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Genomic Changes Associated With the Use of Intradermal Avotermin (Juvista) in Small Wounds in Healthy Male Subjects
Sponsor:
Renovo
Organization:
Study Overview
Official Title:
A Single Centre, Double-blind, Methodology Trial to Investigate the Genomic Changes Associated With Accelerated Healing and Reduced Scarring of Small Wounds Using RN1001 in Healthy Male Subjects
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:
The purpose of this study is to further determine the safety and toleration of intradermal avotermin (Juvista), confirm accelerated healing and investigate genomic expression profiles
Detailed Description:
Subjects were allocated to two groups. Group 1 had scheduled visits on Day 0, 1, 3 and 4 while group 2 were scheduled for Day 0, 1, 5 and 6. Follow-up post-trial safety assessments were made on Day 10-20.
On Day 0 each subject received a total of four 1cm incision wounds; two each to the upper, inner aspect of each arm. Two areas for incision were marked out on the inner aspect of each upper arm and anaesthetised before intradermal injection of Juvista or placebo. One incision site on each arm received a dose of 50ng/100μl Juvista and the other incision site received Placebo. Following injection a full thickness 1cm incision was made along the marked site.
On Day 1 all subjects were re-injected with the same dose of Juvista or placebo, 100μl to each wound margin (200μl per wound site).
On Day 3 subjects in Group 1 were re-dosed with 200μl Juvista or Placebo per site (100μl per linear cm approximated wound margin) in Arm 1. These sites were then excised with an elliptical excision. On Day 4 the same subjects received another dose of Juvista or placebo as before.
Subjects in group 2 received the same treatment to their Arm 1 as those in group 1, except on Day 5 and 6.
All wounds were monitored and photographed at two monthly intervals over the course of 6 months. At month 6, all incision sites on Arm 2 for both groups were excised.
All excised wounds were snap frozen for genomic analysis.
On Day 0 each subject received a total of four 1cm incision wounds; two each to the upper, inner aspect of each arm. Two areas for incision were marked out on the inner aspect of each upper arm and anaesthetised before intradermal injection of Juvista or placebo. One incision site on each arm received a dose of 50ng/100μl Juvista and the other incision site received Placebo. Following injection a full thickness 1cm incision was made along the marked site.
On Day 1 all subjects were re-injected with the same dose of Juvista or placebo, 100μl to each wound margin (200μl per wound site).
On Day 3 subjects in Group 1 were re-dosed with 200μl Juvista or Placebo per site (100μl per linear cm approximated wound margin) in Arm 1. These sites were then excised with an elliptical excision. On Day 4 the same subjects received another dose of Juvista or placebo as before.
Subjects in group 2 received the same treatment to their Arm 1 as those in group 1, except on Day 5 and 6.
All wounds were monitored and photographed at two monthly intervals over the course of 6 months. At month 6, all incision sites on Arm 2 for both groups were excised.
All excised wounds were snap frozen for genomic analysis.
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?: