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| Name | Class |
|---|---|
| Galderma R&D | INDUSTRY |
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This study will evaluates the emotional and functional benefits of Poly-L-Lactic Acid (Sculptra™), a cosmetic product used to fill defects of the skin. All participants will receive Sculptra™.
Facial volume loss can result in emotional distress and functional impairment in some affected individuals. Poly-L-Lactic Acid (Sculptra™) stimulates collagen production in the skin thereby replenishing some of the collagen lost to natural aging and ultraviolet damage. This study will assess the emotional and functional benefits of Poly-L-Lactic Acid treated subject's through self report measurement tools.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Poly-L-Lactic Acid (Sculptra) injection | Other | Poly-L-Lactic Acid (Sculptra) injection for all enrolled subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Poly-L-Lactic Acid (Sculptra) injection | Drug | 1 vial of of poly-l-lactic acid (Sculptra) reconstituted in the usual sterile fashion with 7cc of sterile water and 2cc of Lidocaine without epinephrine. The contents of the vial will be injected as deemed appropriate by the certified injector and agreed upon by the study subject. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Subject Self Reported Quality of Life Scale | Self report Likert Scale Title: Facial Volume Restoration Outcome Questionnaire 35 Questions 1-7 rating with higher score meaning a worse outcome | 3 months post initial injection |
| Mean Rosenberg Self-Esteem Scale | Self reported self esteem measure Title: Rosenberg Self-Esteem Scale Scale of 1-4, scale design with higher score relating to worse outcome. | 3 months post initial injection |
| Mean Rosenberg Self-Esteem Scale | Self reported self esteem measure Title: Rosenberg Self-Esteem Scale Scale of 1-4, scale design with higher score relating to worse outcome. | 6 months post initial injection |
| Mean Subject Self Reported Quality of Life Scale | Self report Likert Scale Title: Facial Volume Restoration Outcome Questionnaire 35 Questions 1-7 rating with higher score meaning a worse outcome | 6 months post initial injection |
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Inclusion Criteria:
Exclusion Criteria:
Any of the previous facial treatments:
c. Any facial filler in the past 2 years d. Prior injection of permanent facial implant
Have any skin pathology or condition that could interfere with the evaluation of the face.
Be unable to communicate or cooperate with the Investigator due to a language barrier (non-English speaking), poor mental development, or impaired cerebral function.
Have evidence of alcohol or drug abuse (Investigator opinion), or history of poor cooperation, non-compliance with medical treatment, or unreliability.
Have used an investigational device, biologic or drug in the past 30 days, or be currently participating in an experimental drug, biologic or device trial.
Have a condition or be in a situation that, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.
Be an employee (or a relative of an employee) of the Investigator, Sponsor or representative of the Sponsor.
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| Label | URL |
|---|---|
| Click here for more information about this study: The Emotional and Functional Benefits of Poly-L-Lactic Acid | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Poly-L-Lactic Acid (Sculptra) Injection | Poly-L-Lactic Acid (Sculptra) injection for all enrolled subjects Poly-L-Lactic Acid (Sculptra) injection: 1 vial of of poly-l-lactic acid (Sculptra) reconstituted in the usual sterile fashion with 7cc of sterile water and 2cc of Lidocaine without epinephrine. The contents of the vial will be injected as deemed appropriate by the certified injector and agreed upon by the study subject. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Poly-L-Lactic Acid (Sculptra) Injection | Poly-L-Lactic Acid (Sculptra) injection for all enrolled subjects Poly-L-Lactic Acid (Sculptra) injection: 1 vial of of poly-l-lactic acid (Sculptra) reconstituted in the usual sterile fashion with 7cc of sterile water and 2cc of Lidocaine without epinephrine. The contents of the vial will be injected as deemed appropriate by the certified injector and agreed upon by the study subject. |
| 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 | Mean Subject Self Reported Quality of Life Scale | Self report Likert Scale Title: Facial Volume Restoration Outcome Questionnaire 35 Questions 1-7 rating with higher score meaning a worse outcome | Posted | Mean | Standard Deviation | units on a scale | 3 months post initial injection |
|
9 Months
Subject population of decreased facial volume not due to concomitant disease state is not considered at higher risk for mortality than age matched general population. In additional Poly-L -Lactic Acid has not been associated with any increased risk of mortality.
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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 | Poly-L-Lactic Acid (Sculptra) Injection | Poly-L-Lactic Acid (Sculptra) injection for all enrolled subjects Poly-L-Lactic Acid (Sculptra) injection: 1 vial of of poly-l-lactic acid (Sculptra) reconstituted in the usual sterile fashion with 7cc of sterile water and 2cc of Lidocaine without epinephrine. The contents of the vial will be injected as deemed appropriate by the certified injector and agreed upon by the study subject. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain/Discomfort | Skin and subcutaneous tissue disorders | Systematic Assessment | expected post procedure pain/discomfort |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Yardley Dermatology Associates, PC | 2155796155 | rfried@yardleyderm.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 21, 2015 | May 7, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C033616 | poly(lactide) |
| C482305 | New-Fill |
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Units |
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| Counts |
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| Participants |
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| Primary | Mean Rosenberg Self-Esteem Scale | Self reported self esteem measure Title: Rosenberg Self-Esteem Scale Scale of 1-4, scale design with higher score relating to worse outcome. | Posted | Mean | Standard Deviation | units on a scale | 3 months post initial injection |
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| Primary | Mean Rosenberg Self-Esteem Scale | Self reported self esteem measure Title: Rosenberg Self-Esteem Scale Scale of 1-4, scale design with higher score relating to worse outcome. | Posted | Mean | Standard Deviation | units on a scale | 6 months post initial injection |
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| Primary | Mean Subject Self Reported Quality of Life Scale | Self report Likert Scale Title: Facial Volume Restoration Outcome Questionnaire 35 Questions 1-7 rating with higher score meaning a worse outcome | Posted | Mean | Standard Deviation | units on a scale | 6 months post initial injection |
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| 0 |
| 50 |
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| 5 |
| 50 |
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