Acne Scarring of the Face
Conditions
Keywords
Acne
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.
Interventions
BIOLOGICALAutologous 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.
BIOLOGICALPlacebo
1. Collection of 3 mm post auricular skin punch biopsies. 2. Administration of 3 study treatments administered 14 ± 7 days apart.
Sponsors
Castle Creek Biosciences, LLC.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
Patients were recruited between 7 Nov 2007 and 6 March 2008
Pre-assignment details
Patients were enrolled and biopsied for manufacture of study product. Patients for whom study product could not be manufactured were excluded from the Intent to Treat (ITT) population.
Participants by arm
| Arm | Count |
|---|---|
| Autologous Fibroblasts and Placebo Patients were treated with autologous fibroblasts on one cheek, and placebo on the opposite cheek | 109 |
| Total | 109 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Treatment & Follow Up | Adverse Event | 2 |
| Treatment & Follow Up | Lost to Follow-up | 10 |
| Treatment & Follow Up | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | Autologous Fibroblasts and Placebo |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 109 Participants |
| Age Continuous | 41.7 years STANDARD_DEVIATION 10.57 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 27 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 82 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 17 Participants |
| Race (NIH/OMB) White | 78 Participants |
| Sex: Female, Male Female | 62 Participants |
| Sex: Female, Male Male | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 11 / 122 | 10 / 122 | 1 / 122 |
| serious Total, serious adverse events | 0 / 122 | 0 / 122 | 1 / 122 |
Outcome results
Primary
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.
Time frame: Baseline (prior to first treatment) and four months after last treatment
Population: Analysis population was the ITT population, defined as subjects for whom product could be produced and who were randomized to study treatment, whether or not all study treatments are actually received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Autologous Fibroblasts Cheeks | Evaluator Live Acne Scarring Assessment Responders | 64 Participants |
| Placebo Cheeks | Evaluator Live Acne Scarring Assessment Responders | 46 Participants |
Comparison: Null hypothesis: no difference in the response rates between the two treatment arms.~Statistical test: McNemar's paired test of proportions Significance level: two sided alpha of 0.05 for each of the two co-primary endpoints.~Assumptions for power calculations:~Response rate for azficel-T treated cheek = 40% Response rate for placebo treated cheek = 20% 10% dropout rate; dropouts counted as failures. Low correlation between cheeks \& 50% correlation between endpointsp-value: 0.0109McNemar
Primary
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.
Time frame: Baseline (prior to first treatment) and four months after last treatment
Population: Analysis was performed on the ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Autologous Fibroblasts Cheeks | Subject Live Acne Scarring Assessment Responders | 47 Cheeks |
| Placebo Cheeks | Subject Live Acne Scarring Assessment Responders | 20 Cheeks |
Comparison: Null hypothesis: no difference in the response rates between the two treatment arms.~Statistical test: McNemar's paired test of proportions Significance level: two sided alpha of 0.05 for each of the two co-primary endpoints.~Assumptions for power calculations:~Response rate for azficel-T treated cheek = 40% Response rate for placebo treated cheek = 20% 10% dropout rate; dropouts counted as failures. Low correlation between cheeks \& 50% correlation between endpointsp-value: <0.0001McNemar
Secondary
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.
Time frame: Baseline (prior to first treatment) compared to one, two, and three months after last treatment
Population: Number of cheeks for analysis was the ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Autologous Fibroblasts Cheeks | Evaluator Live Acne Scarring Assessment Responders | 1 Month Post Treatment | 54 Participants |
| Autologous Fibroblasts Cheeks | Evaluator Live Acne Scarring Assessment Responders | 2 Months Post Treatment | 56 Participants |
| Autologous Fibroblasts Cheeks | Evaluator Live Acne Scarring Assessment Responders | 3 Months Post Treatment | 57 Participants |
| Placebo Cheeks | Evaluator Live Acne Scarring Assessment Responders | 1 Month Post Treatment | 32 Participants |
| Placebo Cheeks | Evaluator Live Acne Scarring Assessment Responders | 2 Months Post Treatment | 41 Participants |
| Placebo Cheeks | Evaluator Live Acne Scarring Assessment Responders | 3 Months Post Treatment | 47 Participants |
Secondary
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.
Time frame: Baseline (prior to first treatment) compared to one, two, and three months after last treatment
Population: Analysis was performed on the ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Autologous Fibroblasts Cheeks | Subject Live Acne Scarring Assessment Responders | 1 Month Post Treatment | 34 Cheeks |
| Autologous Fibroblasts Cheeks | Subject Live Acne Scarring Assessment Responders | 2 Months Post Treatment | 41 Cheeks |
| Autologous Fibroblasts Cheeks | Subject Live Acne Scarring Assessment Responders | 3 Months Post Treatment | 43 Cheeks |
| Placebo Cheeks | Subject Live Acne Scarring Assessment Responders | 3 Months Post Treatment | 20 Cheeks |
| Placebo Cheeks | Subject Live Acne Scarring Assessment Responders | 1 Month Post Treatment | 10 Cheeks |
| Placebo Cheeks | Subject Live Acne Scarring Assessment Responders | 2 Months Post Treatment | 15 Cheeks |