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Platelets are a component of blood, which contain factors which can enhance wound healing. This study proposes to evaluate the clinical response of laugh lines treated with a concentrated preparation of the subject's own platelets injected into or under the skin by taking serial photographs of the subject's face over a 12 week period. Also, the same preparation will be injected into or under the skin of the arm near the elbows, and serial biopsies will be taken over a 12 week period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| platelet rich fibrin matrix | Active Comparator | Both nasolabial folds treated with 0-2 cc of autologous platelet rich fibrin matrix,sufficient to efface nasolabial fold |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet rich fibrin matrix | Biological | 0-2 cc of autologous platelet rich fibrin matrix injected intra and subdermally to effect nasolabial fold. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Wrinkle Assessment Score, Between Pre-treatment and 12 Weeks Post-treatment. | Difference in wrinkle assessment score, values ranging from 0 (least noticeable) to 5 ( most noticeable) (scores on a scale)between pre-treatment and 12 weeks post-treatment. | Difference in Measurements taken Pre-treatment and 12 weeks after treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Wrinkle Assessment Scores Between Pre-treatment and 1 Week | Difference in Wrinkle Assessment Scores, values ranging from 0 (least noticeable) to 5 ( most noticeable) (scores on a scale), between Pre-treatment and 1 week | pre-treatment to 1 week after treatment |
| Difference in Wrinkle Assessment Score Between Pretreatment and 2 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony P Sclafani, MD | The New York Eye & Ear Infirmary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The New York Eye & Ear Infirmary- Otolaryngology Faculty practice satellite | Chappaqua | New York | 10514 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20367676 | Result | Sclafani AP. Platelet-rich fibrin matrix for improvement of deep nasolabial folds. J Cosmet Dermatol. 2010 Mar;9(1):66-71. doi: 10.1111/j.1473-2165.2010.00486.x. |
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Any patient who refused to attend all scheduled follow up visits were to be excluded.
Patients with moderate to severe nasolabial folds were included.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment With Platelet Rich Fibrin Matrix | Both nasolabial folds treated with platelet rich fibrin matrix |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment With Platelet Rich Fibrin Matrix | Both nasolabial folds treated with platelet rich fibrin matrix |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Difference in Wrinkle Assessment Score, Between Pre-treatment and 12 Weeks Post-treatment. | Difference in wrinkle assessment score, values ranging from 0 (least noticeable) to 5 ( most noticeable) (scores on a scale)between pre-treatment and 12 weeks post-treatment. | Number of participants were calculated based on need to achieve 1 unit improvement of Wrinkle Assessment score over baseline (pre-treatment) to be clinically relevant. | Posted | Mean | Standard Deviation | units on a scale | Difference in Measurements taken Pre-treatment and 12 weeks after 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 | Treatment With Platelet Rich Fibrin Matrix | Both nasolabial folds treated with platelet rich fibrin matrix |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anthony P Sclafani, MD | NY Eye & Ear Infirmary | 212-979-4200 | asclafani@nyee.edu |
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Difference in Wrinkle Assessment Scores, values ranging from 0 (least noticeable) to 5 ( most noticeable) (scores on a scale), between Pre-treatment and 2 weeks |
| Pre-treatment to 2 weeks after treatment |
| Difference in Wrinkle Assessment Score Between Pretreatment and 6 Weeks | Difference in Wrinkle Assessment Scores, values ranging from 0 (least noticeable) to 5 ( most noticeable) (scores on a scale), between Pre-treatment and 6 Weeks | Pre-treatment to 6 weeks after treatment |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Difference in Wrinkle Assessment Scores Between Pre-treatment and 1 Week | Difference in Wrinkle Assessment Scores, values ranging from 0 (least noticeable) to 5 ( most noticeable) (scores on a scale), between Pre-treatment and 1 week | The number of participants required to demonstrate a 1 point difference between pre and post treatment values | Posted | Mean | Standard Deviation | units on a scale | pre-treatment to 1 week after treatment |
|
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| Secondary | Difference in Wrinkle Assessment Score Between Pretreatment and 2 Weeks | Difference in Wrinkle Assessment Scores, values ranging from 0 (least noticeable) to 5 ( most noticeable) (scores on a scale), between Pre-treatment and 2 weeks | Posted | Mean | Standard Deviation | units on a scale | Pre-treatment to 2 weeks after treatment |
|
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| Secondary | Difference in Wrinkle Assessment Score Between Pretreatment and 6 Weeks | Difference in Wrinkle Assessment Scores, values ranging from 0 (least noticeable) to 5 ( most noticeable) (scores on a scale), between Pre-treatment and 6 Weeks | Posted | Mean | Standard Deviation | units on a scale | Pre-treatment to 6 weeks after treatment |
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| 0 |
| 15 |
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| 15 |
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