Trial Outcomes & Findings for The Emotional and Functional Benefits of Poly-L-Lactic Acid (NCT NCT02613481)

NCT ID: NCT02613481

Last Updated: 2019-05-29

Results Overview

Self report Likert Scale Title: Facial Volume Restoration Outcome Questionnaire 35 Questions 1-7 rating with higher score meaning a worse outcome

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 50 participants
• Primary outcome timeframe: 3 months post initial injection
• Results posted on: 2019-05-29

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	50
Overall Study COMPLETED	41
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Measure	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.
Overall Study Lost to Follow-up	7
Overall Study Withdrawal by Subject	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Poly-L-Lactic Acid (Sculptra) Injection n=50 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	43 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Sex: Female, Male Female	49 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic or Latino	2 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Non Hispanic or Latino	47 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · American Indian or Alaskan	1 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Hawaiian or Pacific Islander	0 Participants n=5 Participants
Region of Enrollment United States	50 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure

Poly-L-Lactic Acid (Sculptra) Injection n=50 Participants 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.

Mean Subject Self Reported Quality of Life Scale

3.45 units on a scale Standard Deviation 0.39

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure

Poly-L-Lactic Acid (Sculptra) Injection n=50 Participants 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.

Mean Rosenberg Self-Esteem Scale

2.56 units on a scale Standard Deviation .93

PRIMARY outcome

Timeframe: 6 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.

Outcome measures

Measure

Poly-L-Lactic Acid (Sculptra) Injection n=50 Participants 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.

Mean Rosenberg Self-Esteem Scale

2.24 units on a scale Standard Deviation 1.05

PRIMARY outcome

Timeframe: 6 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

Outcome measures

Measure

Poly-L-Lactic Acid (Sculptra) Injection n=50 Participants 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.

Mean Subject Self Reported Quality of Life Scale

3.22 units on a scale Standard Deviation 0.37

Adverse Events

Poly-L-Lactic Acid (Sculptra) Injection

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure

Poly-L-Lactic Acid (Sculptra) Injection n=50 participants at risk 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.

Skin and subcutaneous tissue disorders Pain/Discomfort

10.0% 5/50 • Number of events 5 • 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.

Additional Information

Director of Clinical Trials

Yardley Dermatology Associates, PC

Phone: 2155796155

Email: rfried@yardleyderm.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place