NCT00432211

Juvista (Avotermin) in the Prevention or Improvement of Scar Appearance Following Scar Revision Surgery.

A Double Blind, Placebo Controlled, Randomised Trial to Investigate the Efficacy of Juvista (Avotermin) in the Prevention or Improvement of Scar Appearance Following Scar Revision Surgery.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Renovo · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study is being undertaken to investigate the efficacy and safety of Juvista (given as an intradermal injection of 200ng/100µl per linear centimetre of wound margin) in the prevention or improvement of scar appearance when administered intradermally to approximated wound margins following surgical scar revision. In addition, this study will compare the scar revision techniques of complete excision (excision of the entire scar during one surgical procedure) and staged excision (excision of the outmost segments and central core separately).

Conditions

• Cicatrix

Interventions

Type	Name	Description
DRUG	Avotermin	Complete Excision:- On Day 0,Following wound closure the two outer segments of the wound will receive either Juvista or placebo.100µl of vehicle containing 200ng of Juvista will be injected per linear centimetre into both margins of one segment of the wound,and 100µl of vehicle alone (placebo) will be injected per linear centimetre into the other segment of the wound. There will be a central area (at least 3cm) of untreated wound between the two segments.The treatments will be re-administered to each wound segment (A and B) 24 hours after the first administration. Staged Excision On Day 0, the two end segments of the scar will be excised.Following wound closure each subject will receive 100µl of vehicle containing 200ng of Juvista per linear centimetre intradermally into one wound, and 100µl of vehicle alone (placebo) per linear centimetre into the other wound.The trial treatments will be re-administered to each wound 24 hours after the first administration.

Timeline

• Start date: 2006-05-01
• Primary completion: 2008-07-01
• Completion: 2012-09-01
• First posted: 2007-02-07
• Last updated: 2009-02-04

Locations

1 site across 1 country: United Kingdom