Cicatrix Clinical Trial
Official title:
A Double-Blind, Placebo-Controlled, Randomised Dose Ranging Trial to Investigate the Efficacy of Two Different Dosing Regimens of Avotermin (Juvista) in the Improvement of Scar Appearance When Applied to Approximated Wound Margins in Healthy Volunteers.
This is a single-centre, double-blind, Placebo-controlled, randomised trial. Trial subjects
received four 1cm incisional wounds on the inner aspect of each upper arm (eight in total),
giving four pairs of anatomically matched wound sites per subject. Each subject acted as
their own control. One site from each anatomical wound pair was randomly treated with
intradermally administered avotermin (Juvista:100μL per linear cm of wound site
pre-operatively and 100μL per linear cm of wound margin post-wounding on Day 0 or Day 1,
400μL per wound site) while the second site was a paired control, treated with Placebo
(100μL per linear cm of wound site pre-operatively and 100μL per linear cm of wound margin
post-wounding on Day 0 or Day 1, 400μL per wound site). Wound margins for injection were
defined as extending 0.5cm from either end of the incision. Four doses of avotermin
(Juvista) were administered to each subject: 5ng, 50ng, 200ng and 500ng/100μL per linear cm;
one dose to one wound site per anatomically matched pair of wounds. The second wound site
from each anatomically matched pair of wounds was dosed with placebo. Allocation of
treatment to wound-site pairs was randomised and double blinded.
Primary objective To determine the optimal concentration and dose regimen of Juvista for the
improvement of the resultant scar when applied to the approximated wound margins of male and
female subjects following surgical incisions.
Secondary objective To assess the safety and tolerance of Juvista when applied to the
approximated wound margins of male and female subjects following surgical incisions.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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