drugset / Trial / NCT00649428

Safety and Efficacy Study of Isolagen TherapyTM in the Treatment of Nasolabial Fold Wrinkles

NCT00649428 ↗

Phase 3 Completed 203 enrolled Castle Creek Biosciences, LLC.
RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to evaluate the safety profile and the treatment effect of Isolagen TherapyTM compared with placebo when administered to bilateral nasolabial fold wrinkles.

Timeline

Start
2006-10
Primary completion
2008-07
Completion
2009-05

Outcome

Met primary endpoint

registry Autologous Fibroblast vs Placebo; p = .00001; Cochran-Mantel-Haenszel NCT00649428 ↗

registry Autologous Fibroblasts vs Placebo; p <.00001; Cochran-Mantel-Haenszel NCT00649428 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject azficel-T Cell therapy — Other

Indications

No indication recorded.