78
Participants
Start Date
September 30, 2006
Primary Completion Date
August 31, 2007
Study Completion Date
August 31, 2007
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."
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."
Clinical Trials Unit, Renovo, Manchester
Renovo
INDUSTRY