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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 |
| |
| Control | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Human Fibroblast (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 |
|---|---|---|---|---|---|---|
| Total Skin & Beauty Dermatology Center, PC | Birmingham | Alabama | United States | |||
| Silverburg Surgical & Medical Group |
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 October 23, 2006 and February 9, 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 |
| Newport Beach |
| California |
| 92660 |
| United States |
| Dermatology Research Institute, LLC | Coral Gables | Florida | United States |
| River North Dermatology and Dermatologic Surgery | Naperville | Illinois | United States |
| Aesthetic Solutions | Chapel Hill | North Carolina | United States |
| Dermatology, Laser & Vein Specialists of the Carolinas | Charlotte | North Carolina | United States |
| Center for Skin Research | Houston | Texas | 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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| 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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| 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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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). | 2 | 100 | 32 | 100 | ||
| EG001 | Placebo | Patients treated with placebo solution. | 4 | 103 | 34 | 103 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial Infarction | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Adenocarcimona | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
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| Athralgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
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| Knee Arthroplasty | Surgical and medical procedures | MedDRA (Unspecified) | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Chemical Abuser | Social circumstances | 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 |
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| Injection Site Erythema | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Injection Site Pain | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Injection Site Swelling | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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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.
| 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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