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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Double blinded active | Experimental | Subject will receive autologous fibroblast treatment on either their left or right side of their face |
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| Double blinded placebo | Placebo Comparator | Subject will receive placebo treatment on the opposite side of the face from active treatment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Human Fibroblasts (azficel-T) | Biological |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brighton Medical Corporation | Beverly Hills | California | 90210 | United States | ||
| Therapeutics Clinical Research |
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.
Patients were recruited between 7 Nov 2007 and 6 March 2008
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| ID | Title | Description |
|---|---|---|
| FG000 | Autologous Fibroblasts and Placebo | Patients were treated with autologous fibroblasts on one cheek, and placebo on the opposite cheek |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Biopsy & Product Manufacture |
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| Placebo | Biological |
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| 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 |
| San Diego |
| California |
| 92123 |
| United States |
| The Laser Institute for Dermatology | Santa Monica | California | 90404 | United States |
| Dermatology Research Institute, LLC | Coral Gables | Florida | 33146 | United States |
| Maryland Laser, Skin and Vein Institute | Hunt Valley | Maryland | 21030 | United States |
| Sadick Dermatology | New York | New York | 10021 | United States |
| Dermatology, Laser and Vein Specialists of the Carolinas | Charlotte | North Carolina | 28207 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| Treatment & Follow Up |
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| ID | Title | Description |
|---|---|---|
| BG000 | Autologous Fibroblasts and Placebo | Patients were treated with autologous fibroblasts on one cheek, and placebo on the opposite cheek |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | Participants | Baseline (prior to first treatment) and four months after last treatment |
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| 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. | Analysis was performed on the ITT population | Posted | Number | Cheeks | Baseline (prior to first treatment) and four months after last treatment |
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| 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. | Number of cheeks for analysis was the ITT population | Posted | Number | Participants | Baseline (prior to first treatment) compared to one, two, and three months after last treatment |
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| 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. | Analysis was performed on the ITT population | Posted | Number | Cheeks | Baseline (prior to first treatment) compared to one, two, and three months after last treatment |
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Adverse events were collected from the time of patient biopsy through the final study visit, four months after final study treatment (five months after first study treatment).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Autologous Fibroblast Cheeks | Cheeks randomized to receive autologous fibroblast treatment | 0 | 122 | 11 | 122 | ||
| EG001 | Placebo Cheeks | Cheeks randomized to receive placebo treatment | 0 | 122 | 10 | 122 | ||
| EG002 | Non-treatment Area Adverse Events | Systemic adverse events and adverse events that occured outside of the study treatment area will be reported in this group | 1 | 122 | 1 | 122 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment | Patient treated for overdose of recreational drugs after being biopsied and enrolled in the study, but prior to receiving any study treatment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment | Administration site condition |
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| Swelling | General disorders | MedDRA (10.0) | Non-systematic Assessment | Administration site conditions |
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Publications or presentations by the Investigator or his associates, were required to be submitted to the sponsor for review and approval prior to publication or presentation in any form.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr/ Joseph Fratantoni | Biologics Consulting Group | (301) 340-8432 | jfratantoni@bcg-usa.com |
| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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