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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

Brief 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).


Detailed Summary:
Sponsor: Renovo

Current Primary Outcome:

  • Investigator scar assessment [ Time Frame: up to 7 month visit ]
  • Patient scar assessment [ Time Frame: up to 7 month visit ]
  • Independent scar assessment [ Time Frame: up to month 7 ]


Original Primary Outcome:

  • Investigator scar assessment
  • Patient scar assessment
  • Independent scar assessment


Current Secondary Outcome:

  • Local tolerability [ Time Frame: up to month 7 ]
  • Adverse events [ Time Frame: up to month 7 ]


Original Secondary Outcome:

  • Local tolerability
  • Adverse events


Information By: Renovo

Dates:
Date Received: February 6, 2007
Date Started: May 2006
Date Completion: September 2012
Last Updated: February 3, 2009
Last Verified: February 2009