Clinical Trial: Improvement in Scar Appearance Following Injection of Avotermin (Juvista) Into Skin Incisions Made in Healthy Men and Women

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary:

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.

Detailed Summary:
Sponsor: Renovo

Current Primary Outcome: To determine the optimal concentration and dose regimen of avotermim (Juvista) for the improvement of the resultant scar when applied to the approximated wound margins of male and female subjects following surgical incisions. [ Time Frame: Post surgery: week 6 to Month 7 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: To assess the safety and tolerance of avotermin (Juvista) when applied to the approximated wound margins of male and female subjects following surgical incisions. [ Time Frame: Day 0 (surgery) to Month 7 post surgery ]

Original Secondary Outcome: Same as current

Information By: Renovo

Dates:
Date Received: February 26, 2008
Date Started: September 2006
Date Completion:
Last Updated: February 26, 2008
Last Verified: February 2008