NCT00642642

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

A Phase II/III Double-Blind, Randomized, Placebo-Controlled Trial of the Safety and Efficacy of Isolagen Therapy in the Treatment of Moderate to Sever Facial Acne Scarring

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Castle Creek Biosciences, LLC. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acne Scarring of the Face

Interventions

Type	Name	Description
BIOLOGICAL	Autologous Human Fibroblasts (azficel-T)	1. Collection of 3 mm post auricular skin punch biopsies. 2. Administration of 3 study treatments administered 14 ± 7 days apart.
BIOLOGICAL	Placebo	1. Collection of 3 mm post auricular skin punch biopsies. 2. Administration of 3 study treatments administered 14 ± 7 days apart.

Timeline

• Start date: 2007-11-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2008-03-25
• Last updated: 2013-08-21
• Results posted: 2013-08-21

Locations

7 sites across 1 country: United States