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

PHASE2CompletedINTERVENTIONAL
Enrollment

78

Participants

Timeline

Start Date

September 30, 2006

Primary Completion Date

August 31, 2007

Study Completion Date

August 31, 2007

Conditions
Cicatrix
Interventions
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."

Trial Locations (1)

M139XX

Clinical Trials Unit, Renovo, Manchester

All Listed Sponsors
lead

Renovo

INDUSTRY

NCT00629811 - Improvement in Scar Appearance Following Injection of Avotermin (Juvista) Into Skin Incisions Made in Healthy Men and Women | Biotech Hunter | Biotech Hunter