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The purpose of this study is to evaluate the safety profile and the treatment effect of Isolagen TherapyTM compared with placebo when administered to bilateral nasolabial fold wrinkles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental |
| |
| Placebo | Placebo Comparator |
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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 |
|---|---|---|
| Subject Wrinkle Assessment Responders | A two point improvement on the Subject's live assessment of the wrinkles of the lower part of the face as compared to baseline on the Subject Wrinkle Assessment was considered a responder. The Subject Wrinkle Assessment scale was a five point scale with a score of -2 (Very Dissatisfied) being the worst and a score of +2 (Very Satisfied) being the best. | Baseline (prior to first treatment) and 6 months post final treatment |
| Evaluator Wrinkle Severity Assessment Responders | A responder was defined as a two point improvement on the blinded Evaluator's live assessment of each of the bilateral nasolabial fold wrinkles at rest using the 6-point ordinal Lemperle Wrinkle Severity Scale. On the Lemperle scale, a score of 5 (Very Deep Wrinkle) is worst and a score of 0 (No Visible Wrinkle) is best. | Baseline (prior to first treatment) and 6 months after last treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Subject Wrinkle Assessment Responders | A two point improvement on the Subject's live assessment of the wrinkles of the lower part of the face as compared to baseline on the Subject Wrinkle Assessment was considered a responder. The Subject Wrinkle Assessment scale was a five point scale with a score of -2 (Very Dissatisfied) being the worst and a score of +2 (Very Satisfied) being the best. | Baseline (prior to first treatment) compared to 3rd treatment visit, 2 and 4 months post final 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 | 91210 | United States | ||
| Therapeutics Clinical Research |
Patients were enrolled and biopsied for manufacture of study product. All randomized patients were included in the Intent to Treat (ITT) population.
Patients were recruited between 1 November 2006 to 27 January 2007
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| ID | Title | Description |
|---|---|---|
| FG000 | Autologous Fibroblasts | Patients treated with autologous dermal fibroblasts |
| FG001 | Placebo | Patients treated with placebo solution |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo | Biological |
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| Evaluator Wrinkle Severity Assessment Responders | A responder was defined as a two point improvement on the blinded Evaluator's live assessment of each of the bilateral nasolabial fold wrinkles at rest using the 6-point ordinal Lemperle Wrinkle Severity Scale. On the Lemperle scale, a score of 5 (Very Deep Wrinkle) is worst and a score of 0 (No Visible Wrinkle) is best. | Baseline (prior to first treatment) compared to 3rd treatment visit, 2 and 4 months post final treatment |
| San Diego |
| California |
| 92123 |
| United States |
| Gwinnett Clinical Research Center | Snellville | Georgia | 30078 | United States |
| Dermatology San Antonio | San Antonio | Texas | 78229 | United States |
| Charlottesville Medical Research | Charlottesville | Virginia | 22911 | United States |
| Institute of Anti Aging Research | Virginia Beach | Virginia | 23454 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Autologous Fibroblasts | Patients treated with autologous dermal fibroblasts |
| BG001 | Placebo | Patients treated with placebo solution |
| BG002 | Total | Total of all reporting groups |
| 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 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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| Region of Enrollment | Number | 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 | Subject Wrinkle Assessment Responders | A two point improvement on the Subject's live assessment of the wrinkles of the lower part of the face as compared to baseline on the Subject Wrinkle Assessment was considered a responder. The Subject Wrinkle Assessment scale was a five point scale with a score of -2 (Very Dissatisfied) being the worst and a score of +2 (Very Satisfied) being the best. | Analysis population was the ITT population, defined as all randomized subjects. | Posted | Number | participants | Baseline (prior to first treatment) and 6 months post final treatment |
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| Primary | Evaluator Wrinkle Severity Assessment Responders | A responder was defined as a two point improvement on the blinded Evaluator's live assessment of each of the bilateral nasolabial fold wrinkles at rest using the 6-point ordinal Lemperle Wrinkle Severity Scale. On the Lemperle scale, a score of 5 (Very Deep Wrinkle) is worst and a score of 0 (No Visible Wrinkle) is best. | Analysis population was the ITT population, defined as all randomized subjects. | Posted | Number | participants | Baseline (prior to first treatment) and 6 months after last treatment |
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| Secondary | Subject Wrinkle Assessment Responders | A two point improvement on the Subject's live assessment of the wrinkles of the lower part of the face as compared to baseline on the Subject Wrinkle Assessment was considered a responder. The Subject Wrinkle Assessment scale was a five point scale with a score of -2 (Very Dissatisfied) being the worst and a score of +2 (Very Satisfied) being the best. | Analysis population was the ITT population, defined as all randomized subjects. | Posted | Number | participants | Baseline (prior to first treatment) compared to 3rd treatment visit, 2 and 4 months post final treatment |
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| Secondary | Evaluator Wrinkle Severity Assessment Responders | A responder was defined as a two point improvement on the blinded Evaluator's live assessment of each of the bilateral nasolabial fold wrinkles at rest using the 6-point ordinal Lemperle Wrinkle Severity Scale. On the Lemperle scale, a score of 5 (Very Deep Wrinkle) is worst and a score of 0 (No Visible Wrinkle) is best. | Analysis population was the ITT population, defined as all randomized subjects. | Posted | Number | participants | Baseline (prior to first treatment) compared to 3rd treatment visit, 2 and 4 months post final treatment |
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Adverse events were collected from the baseline visit through the final study visit, 6 months after final 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 Fibroblasts | Patients treated with autologous fibroblasts (azficel-T). | 8 | 98 | 32 | 98 | ||
| EG001 | Placebo | Patients treated with placebo solution. | 7 | 99 | 33 | 99 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Spinal Column Stenosis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Retinal Detachment | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Staphylococcal Infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Endometriosis | Reproductive system and breast disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Cervical Vertebral Fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
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| Nephrectomy | Surgical and medical procedures | MedDRA (Unspecified) | Non-systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
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| Angina Pectoris | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Coronary Artery Disease | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Rib Fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
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| Impaired Gastric Emptying | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Uterine Leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
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| Subarachnoid Hemorrhage | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Spondylolisthesis | Congenital, familial and genetic disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Cardiac Arrest | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site bruising | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Injection site haemorrhage | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
Publications or presentations by the Investigator or his associates, were required to be submitted to the sponsor for review and approval.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kevin Hennegan | CBR International Corp. | 720-746-1190 | khennegan@cbrintl.com |
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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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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