drugset / Trial / NCT00710333

Safety of Juvista When Administered Following Excision of Ear Lobe Keloids

NCT00710333

Phase 1/2 Completed 10 enrolled Renovo
RandomizedParallel-groupTriple-blindTreatment

Summary

This trial will assess the safety and efficacy of 500ng 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.

Timeline

Start
2008-07
Primary completion
2009-10
Completion
2009-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Avotermin Protein / enzyme biologic 500 ng Intrathecal

Indications