drugset / Trial / NCT00469235

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

NCT00469235

Phase 1/2 Completed 20 enrolled Renovo
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2007-06
Primary completion
2009-03
Completion
2009-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Avotermin Protein / enzyme biologic 50 ng Other
Comparator Avotermin Protein / enzyme biologic 200 ng Other

Indications