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

Facial Volume Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02613481
• Other study ID #: YDA-001
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: August 1, 2017

Study information

• Verified date: May 2019
• Source: Yardley Dermatology Associates
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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™.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 1, 2017
• Est. primary completion date: June 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Facial Volume Loss

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Yardley Dermatology Associates	Galderma Laboratories, L.P.

Outcome

Type	Measure	Description	Time frame	Safety issue
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	3 months post initial injection
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.	3 months post initial injection
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.	6 months post initial injection
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	6 months post initial injection

External Links

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