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

Phase 2

Completed

• Conditions: Acne Scarring of the Face
• Interventions: Biological: Autologous Human Fibroblasts (azficel-T); Biological: Placebo

• Registration Number: NCT00642642
• Lead Sponsor: Castle Creek Biosciences, LLC.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2008-03-19
• Study First Submitted QC: 2008-03-19
• Study First Posted: 2008-03-25
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Results First Submitted: 2012-02-09
• Status Verified: 2013-07
• Results First Submitted QC: 2013-07-19
• Last Update Submitted: 2013-07-19
• Results First Posted: 2013-08-21
• Last Update Posted: 2013-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Double blinded active	Autologous Human Fibroblasts (azficel-T)	Subject will receive autologous fibroblast treatment on either their left or right side of their face
Double blinded placebo	Placebo	Subject will receive placebo treatment on the opposite side of the face from active treatment

Primary Outcome Measures

Name	Time	Method
Evaluator Live Acne Scarring Assessment Responders	Baseline (prior to first treatment) and four months after last treatment	Subjects who improved by 1 point or more on the Evaluator Live Acne Scarring Assessment (ELASA), as assessed by the evaluating Investigator, are counted as responders. On the ELASA scale, a score of 0 (Clear) is best and a score of 4 (Severe) is worst.
Subject Live Acne Scarring Assessment Responders	Baseline (prior to first treatment) and four months after last treatment	Cheeks that improved by at least two points on the Subject Live Acne Scarring Assessment (SLASA) as scored by the subject were considered responders. On the SLASA scale, a score of -2 (Very Dissatisfied) was worst and a score of 2 (Very Satisfied) was best.

Secondary Outcome Measures

Name	Time	Method
Evaluator Live Acne Scarring Assessment Responders	Baseline (prior to first treatment) compared to one, two, and three months after last treatment	Subjects who improved by 1 point or more on the Evaluator Live Acne Scarring Assessment (ELASA), as assessed by the evaluating Investigator, are counted as responders. On the ELASA scale, a score of 0 (Clear) is best and a score of 4 (Severe) is worst.
Subject Live Acne Scarring Assessment Responders	Baseline (prior to first treatment) compared to one, two, and three months after last treatment	Cheeks that improved by at least two points on the Subject Live Acne Scarring Assessment (SLASA) as scored by the subject were considered responders. On the SLASA scale, a score of -2 (Very Dissatisfied) was worst and a score of 2 (Very Satisfied) was best.

Trial Locations

Locations (7)

The Laser Institute for Dermatology; 🇺🇸 Santa Monica, California, United States

Maryland Laser, Skin and Vein Institute; 🇺🇸 Hunt Valley, Maryland, United States

Therapeutics Clinical Research; 🇺🇸 San Diego, California, United States

Brighton Medical Corporation; 🇺🇸 Beverly Hills, California, United States

Dermatology Research Institute, LLC; 🇺🇸 Coral Gables, Florida, United States

Sadick Dermatology; 🇺🇸 New York, New York, United States

Dermatology, Laser and Vein Specialists of the Carolinas; 🇺🇸 Charlotte, North Carolina, United States