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

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.

Inclusion Criteria:

1. Male or female, between 18 years and 65 years of age.
2. Investigator assessment of the acne scarring on each cheek of moderate to severe.
3. A history of acne scarring for more than 3 years.
4. Subject assesses the appearance of both sides of their facial acne scars as dissatisfied or very dissatisfied with appearance.

Exclusion Criteria:

1. Significant active acne.
2. Use of oral antibiotic or retinoid active acne therapy within one year of enrollment.
3. Presence of hypertrophic scars on the cheeks.
4. More than 20% of treatment area comprised of ice pick scars or sinus tracts
5. Treatment area per cheek is less than 9 cm x cm
6. Unilateral or unbalanced acne scar distribution.
7. Physical attributes which prevent the assessment or treatment of the acne scars.
8. Treatment with an investigational product or procedure within 30 days prior to study enrollment or plans to participate in another clinical trial during the course of this study.
9. Previous treatment with Isolagen TherapyTM.
10. Use of Isotretinoin within one year of enrollment into study.
11. Use of permanent or semi-permanent dermal fillers in the treatment areas within defined time frames.
12. Disorders or drugs that increase bleeding or clotting.
13. Pregnant or lactating women or women trying to become pregnant during the study.
14. Excessive exposure to sun.
15. Smoking more than ½ pack of cigarettes per day.