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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Acne Scarring of the Face

Intervention / Treatment
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* Biological: Autologous Human Fibroblasts (azficel-T)
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, between 18 years and 65 years of age. Investigator assessment of the acne scarring on each cheek of moderate to severe. A history of acne scarring for more than 3 years. Subject assesses the appearance of both sides of their facial acne scars as dissatisfied or very dissatisfied with appearance. Exclusion Criteria: Significant active acne. Use of oral antibiotic or retinoid active acne therapy within one year of enrollment. Presence of hypertrophic scars on the cheeks. More than 20% of treatment area comprised of ice pick scars or sinus tracts Treatment area per cheek is less than 9 cm x cm Unilateral or unbalanced acne scar distribution. Physical attributes which prevent the assessment or treatment of the acne scars. 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. Previous treatment with Isolagen TherapyTM. Use of Isotretinoin within one year of enrollment into study. Use of permanent or semi-permanent dermal fillers in the treatment areas within defined time frames. Disorders or drugs that increase bleeding or clotting. Pregnant or lactating women or women trying to become pregnant during the study. Excessive exposure to sun. Smoking more than ½ pack of cigarettes per day.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Double blinded active<br>Subject will receive autologous fibroblast treatment on either their left or right side of their face | Biological: Autologous Human Fibroblasts (azficel-T)<br>* Collection of 3 mm post auricular skin punch biopsies. Administration of 3 study treatments administered 14 ± 7 days apart.<br>* Other names: LAVIV;|
| Placebo Comparator: Double blinded placebo<br>Subject will receive placebo treatment on the opposite side of the face from active treatment | Biological: Placebo<br>* Collection of 3 mm post auricular skin punch biopsies. Administration of 3 study treatments administered 14 ± 7 days apart.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluator Live Acne Scarring Assessment Responders | 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. | Baseline (prior to first treatment) and four months after last treatment | 
| Subject Live Acne Scarring Assessment Responders | 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. | Baseline (prior to first treatment) and four months after last treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluator Live Acne Scarring Assessment Responders | 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. | Baseline (prior to first treatment) compared to one, two, and three months after last treatment | 
| Subject Live Acne Scarring Assessment Responders | 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. | Baseline (prior to first treatment) compared to one, two, and three months after last treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acne