NCT00629811

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

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Renovo · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cicatrix

Interventions

Type	Name	Description
DRUG	Avotermin (Juvista)	Intradermal avotermin administered to four wound sites per subject, one wound site per anatomically matched pair, according to the subject's assigned dose group: * Group 1: avotermin concentrations of 5, 50, 200 and 500ng per 100μL per linear cm of wound site (pre-wounding, Day 0) and 100μL per linear cm of wound margin (post-wounding, Day 1) * Group 2: avotermin concentrations of 5, 50, 200 and 500ng per 100μL per linear cm of wound site (pre-wounding, Day 0) and 100μL per linear cm of wound margin (post-wounding, Day 0) Each subject received four doses of active drug at concentrations of 5, 50, 200 and 500ng per 100μL per linear cm of wound site, one dose to one wound site per anatomically matched pair of wounds.
DRUG	Placebo	Reference therapy was Placebo (vehicle). On Day 0, the four sites randomised to receive Placebo were administered with a 100μL intradermal injection of Placebo. Subjects in Group 2 were dosed again on Day 0 at 10 to 30 minutes after wound closure. Subjects in Group 1 were dosed again on Day 1 at 24 (+/-4) hours after initial administration of drug.

Timeline

• Start date: 2006-09-01
• Primary completion: 2007-08-01
• Completion: 2007-08-01
• First posted: 2008-03-06
• Last updated: 2008-03-06

Locations

1 site across 1 country: United Kingdom