Clinical Trial: Anti-Scarring Efficacy and Safety of Intradermal Juvista (Avotermin) in Healthy Males

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Single-Site, Double-Blind, Phase II Trial to Investigate the Safety, Toleration, Systemic Exposure and Anti-Scarring Potential of Different Applications of Intradermal J

Brief Summary: This study was undertaken to investigate safety and scar-improvement activity of different applications of Juvista (avotermin), administered to surgical incisions made to the skin of a healthy population of male volunteers aged 18-45 years. The study addressed two issues: whether Juvista (avotermin) administered at 200ng/100μl/linear cm wound margin is more effective than 50ng/100μl/linear cm for scar improvement and, secondly, whether dosing once only (before wounding) or twice (before and after wounding) is optimal for scar improvement.

Detailed Summary:
Sponsor: Renovo

Current Primary Outcome: Scar appearance [ Time Frame: 12 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Safety: adverse events, local tolerability, systemic exposure [ Time Frame: 12 months ]

Original Secondary Outcome: Same as current

Information By: Renovo

Dates:
Date Received: December 11, 2007
Date Started: October 2003
Date Completion:
Last Updated: January 2, 2008
Last Verified: January 2008