Safety and Efficacy Study of Autologous Fibroblasts in the Treatment of Severe Facial Acne Scarring

Summary

The purpose of this study is to evaluate the safety profile and the treatment effect of Isolagen TherapyTM and placebo when administered to facial acne scars.

Timeline

Start

2007-11

Primary completion

2009-03

Completion

2009-03

Outcome

Met primary endpoint

registry Autologous Fibroblasts Cheeks vs Placebo Cheeks; p = 0.0109; McNemar; note: a priori threshold for statistical significance was 0.05 NCT00642642 ↗

registry Autologous Fibroblast Cheeks vs Placebo Cheeks; p <0.0001; McNemar; note: a priori threshold for statistical significance = 0.05 NCT00642642 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	azficel-T	Cell therapy	—	—

Indications