Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the safety profile and the treatment effect of autologous human fibroblasts and placebo when administered to facial wrinkles and creases
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Human Fibroblasts (azficel-T) | Biological |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Subject Assessment of Wrinkles Compared to Baseline on Subject Wrinkle Assessment | Subject Wrinkle Assessment was a five point ordinal scale that assessed the subject's assessment of the appearance of their face. A score of -2 (very dissatisfied) was the worst and a score of +2 (very satisfied) was the best. | Baseline (prior to first treatment) compared to 6 months post last treatment |
| Independent Panel Global Improvement Assessment Compared to Baseline | An independent panel of physicians reviewed photographs of subjects at baseline and 6 months after final study treatment and provided a score for improvement in appearance on the Global Improvement Assessment. The Global Improvement Assessment was a four point ordinal scale with 0 (No improvement) as the worst score and 3 (Marked Improvement) the best. | Baseline (prior to treatment) compared to 6 months post last treatment |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rhonda Rand, M.D., Inc. | Beverly Hills | California | 90210 | United States | ||
| The Laser Institute for Dermatology |
Not provided
Patients were recruited between 22 March 2007 and 8 August 2007
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Autologous Fibroblasts | Patients received treatment with autologous fibroblasts to multiple facial regions |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Autologous Fibroblasts | Patients received treatment with autologous fibroblasts to multiple facial regions |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | Change in Subject Assessment of Wrinkles Compared to Baseline on Subject Wrinkle Assessment | Subject Wrinkle Assessment was a five point ordinal scale that assessed the subject's assessment of the appearance of their face. A score of -2 (very dissatisfied) was the worst and a score of +2 (very satisfied) was the best. | Number of subjects for whom data were available from the assessment visit, 6 months after the final treatment | Posted | Number | participants | Baseline (prior to first treatment) compared to 6 months post last treatment |
|
|
Adverse event data were collected for six months after final study treatment
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active | Patients treated with autologous human fibroblasts |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dehydration | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment | SAE occurred prior to study treatment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kevin Hennegan | CBR International Corp. | (720)746-1190 | khennegan@cbrintl.com |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Santa Monica |
| California |
| 90404 |
| United States |
| Winter Park and Orlando Plastic Surgery | Orlando | Florida | 32804 | United States |
| Dermatology Partners | Wellesley | Massachusetts | 02481 | United States |
| Dermatology, Laser and Vein Specialists of the Carolinas | Charlotte | North Carolina | 28207 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Counts |
|---|
| Participants |
|
|
| Primary | Independent Panel Global Improvement Assessment Compared to Baseline | An independent panel of physicians reviewed photographs of subjects at baseline and 6 months after final study treatment and provided a score for improvement in appearance on the Global Improvement Assessment. The Global Improvement Assessment was a four point ordinal scale with 0 (No improvement) as the worst score and 3 (Marked Improvement) the best. | Number of patients for whom data were available | Posted | Number | participants | Baseline (prior to treatment) compared to 6 months post last treatment |
|
|
|
| 2 |
| 50 |
| 17 |
| 50 |
|
| Alcoholism | Psychiatric disorders | MedDRA (9.0) | Non-systematic Assessment | SAE occurred prior to study treatment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment | SAE occurred after study treatment, and was considered unrelated by the Investigator. |
|
| Headache | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Injection site bruising | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Injection site nodule | General disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Nasophayngitis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
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 | Measurements |
|---|---|
|
| Marked improvement |
|