Wound Healing Clinical Trial
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
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
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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