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

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™.

Study Overview

• Status: Completed
• Conditions: Facial Volume Loss
• Intervention / Treatment: Drug: Poly-L-Lactic Acid (Sculptra) injection

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Poly-L-Lactic Acid (Sculptra) injection; Poly-L-Lactic Acid (Sculptra) injection for all enrolled subjects	Drug: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Yardley Dermatology Associates
• Collaborators: Galderma R&D

Publications and helpful links

Helpful Links

• Click here for more information about this study: The Emotional and Functional Benefits of Poly-L-Lactic Acid

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: October 29, 2015
• First Submitted That Met QC Criteria: November 23, 2015
• First Posted (Estimate): November 24, 2015

Study Record Updates

• Last Update Posted (Actual): May 29, 2019
• Last Update Submitted That Met QC Criteria: May 7, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: YDA-001