NCT00594581

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

A Single-Site, Double-Blind, Phase II Trial to Investigate the Safety, Toleration, Systemic Exposure and Anti-Scarring Potential of Different Applications of Intradermal Juvista (Avotermin) in Male Subjects Aged 18-45 Years

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Renovo · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cicatrix

Interventions

Type	Name	Description
DRUG	Juvista (avotermin) plus placebo, standard-care (within-subject controls)	Intradermal Juvista (avotermin) at 50ng or 200ng per 100μl per linear cm of wound margin

Timeline

• Start date: 2003-10-01
• Completion: 2005-03-01
• First posted: 2008-01-15
• Last updated: 2008-01-15

Locations

1 site across 1 country: United Kingdom