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

Castle Creek Biosciences

Status and phase: Completed; Phase 3; Phase 2

Conditions: Acne Scarring of the Face

Treatments: Biological: Placebo; Biological: Autologous Human Fibroblasts (azficel-T)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00642642

IT-A-008

Details and patient eligibility

About

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.

Enrollment: 122 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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122 participants in 2 patient groups, including a placebo group

Double blinded active

Experimental group

Description:

Subject will receive autologous fibroblast treatment on either their left or right side of their face

Treatment:

Biological: Autologous Human Fibroblasts (azficel-T)

Double blinded placebo

Placebo Comparator group

Description:

Subject will receive placebo treatment on the opposite side of the face from active treatment

Treatment:

Biological: Placebo