Facial Volume Loss
Conditions
Brief summary
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
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.
Interventions
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.
Sponsors
Galderma R&D
Yardley Dermatology Associates
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
1. Subject must be an outpatient, male or female subjects of any race, 35 years of age or older. 2. Subject must have any degree of facial volume loss. 3. Subjects of all Fitzpatrick skin types are eligible. 4. Subject must be able to follow study instructions and likely to complete all required visits, as assessed by the Investigator. 5. 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
1. Any of the previous facial treatments: c. Any facial filler in the past 2 years d. Prior injection of permanent facial implant 2. Have any skin pathology or condition that could interfere with the evaluation of the face. 3. Be unable to communicate or cooperate with the Investigator due to a language barrier (non-English speaking), poor mental development, or impaired cerebral function. 4. Have evidence of alcohol or drug abuse (Investigator opinion), or history of poor cooperation, non-compliance with medical treatment, or unreliability. 5. 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. 6. 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. 7. Be an employee (or a relative of an employee) of the Investigator, Sponsor or representative of the Sponsor.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Subject Self Reported Quality of Life Scale | 3 months post initial injection | Self report Likert Scale Title: Facial Volume Restoration Outcome Questionnaire 35 Questions 1-7 rating with higher score meaning a worse outcome |
| Mean Rosenberg Self-Esteem Scale | 3 months post initial injection | Self reported self esteem measure Title: Rosenberg Self-Esteem Scale Scale of 1-4, scale design with higher score relating to worse outcome. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 50 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 7 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Poly-L-Lactic Acid (Sculptra) Injection |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 43 Participants |
| Race/Ethnicity, Customized Ethnicity American Indian or Alaskan | 1 Participants |
| Race/Ethnicity, Customized Ethnicity Hawaiian or Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Ethnicity Hispanic or Latino | 2 Participants |
| Race/Ethnicity, Customized Ethnicity Non Hispanic or Latino | 47 Participants |
| Region of Enrollment United States | 50 Participants |
| Sex: Female, Male Female | 49 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 50 |
| other Total, other adverse events | 5 / 50 |
| serious Total, serious adverse events | 0 / 50 |
Outcome results
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.
Time frame: 3 months post initial injection
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Poly-L-Lactic Acid (Sculptra) Injection | Mean Rosenberg Self-Esteem Scale | 2.56 units on a scale | Standard Deviation 0.93 |
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.
Time frame: 6 months post initial injection
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Poly-L-Lactic Acid (Sculptra) Injection | Mean Rosenberg Self-Esteem Scale | 2.24 units on a scale | Standard Deviation 1.05 |
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
Time frame: 3 months post initial injection
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Poly-L-Lactic Acid (Sculptra) Injection | Mean Subject Self Reported Quality of Life Scale | 3.45 units on a scale | Standard Deviation 0.39 |
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
Time frame: 6 months post initial injection
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Poly-L-Lactic Acid (Sculptra) Injection | Mean Subject Self Reported Quality of Life Scale | 3.22 units on a scale | Standard Deviation 0.37 |