NCT00469235

Trial of Juvista (Avotermin) Following Removal of Ear Lobe Keloid Scars

A Single-centre, Double Blind, Randomised, Rising Dose Tolerance Study to Investigate the Safety of Juvista When Administered Following Excision of Ear Lobe Keloids.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Renovo · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This trial will assess the safety and efficacy of 50 and 200ng Juvista per linear cm of wound margin administered by intradermal injection following the excision of keloid scars on the ear lobe. Ear lobe keloids commonly occur after ear piercing and can be particularly distressing for patients as they are very difficult to conceal and are usually bilateral. As the recurrence rate and growth rate of keloids can vary significantly between individuals, trial subjects will have bilateral ear lobe keloids and will act as their own control. One ear lobe will be treated with Juvista following keloid excision and one with placebo.

Conditions

• Keloid

Interventions

Type	Name	Description
DRUG	Avotermin	10 patients:- 50ng/100μL Juvista administered by intradermal injection to each linear centimetre of one ear lobe wound margin immediately after and then 24h after wound closure versus 100 μL of placebo administered by intradermal injection to each linear centimetre of the other ear lobe wound margin immediately after and then 24h after wound closure. 10 Patients:- 200ng/100μL Juvista administered by intradermal injection to each linear centimetre of one ear lobe wound margin immediately after and then 24h after wound closure versus 100 μL of placebo administered by intradermal injection to each linear centimetre of the other ear lobe wound margin immediately after and then 24h after wound closure.

Timeline

• Start date: 2007-06-01
• Primary completion: 2009-03-01
• Completion: 2009-05-01
• First posted: 2007-05-04
• Last updated: 2009-09-16

Locations

1 site across 1 country: United States