The Emotional and Functional Benefits of Poly-L-Lactic Acid

Study Overview
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Brief Summary
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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™.

Detailed Description
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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.

Official Title
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The Emotional and Functional Benefits of Poly-L-Lactic Acid

Conditions
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Facial Volume Loss

Intervention / Treatment
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* Drug: Poly-L-Lactic Acid (Sculptra) injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must be an outpatient, male or female subjects of any race, 35 years of age or older. Subject must have any degree of facial volume loss. Subjects of all Fitzpatrick skin types are eligible. Subject must be able to follow study instructions and likely to complete all required visits, as assessed by the Investigator. Subject must sign an IRB-approved Informed Consent form, Photographic Release Form, and the Authorization for Use and release of Health and Research Study Information (HIPAA) form prior to any study-related procedures being performed. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Poly-L-Lactic Acid (Sculptra) injection<br>Poly-L-Lactic Acid (Sculptra) injection for all enrolled subjects | Drug: Poly-L-Lactic Acid (Sculptra) injection<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |