Trial Outcomes & Findings for A Study to Evaluate the Effectiveness of Juvéderm® VOLIFT®™ With Lidocaine for Dynamic Radial Cheek Line Skin Depressions (NCT NCT02980783)
NCT ID: NCT02980783
Last Updated: 2019-02-15
Results Overview
Participants graded the improvement of their dynamic radial cheek lines using the GAIS 5-point scale where -2=much worse to +2=much improved. Participants who rated their improvement as -2, -1, or 0 (much worse, worse, or no change, respectively) were grouped as Not Improved and those who rated their improvement as +1 or +2 (improved or much improved, respectively) were grouped as Improved. The percentages of participants who rated their cheek lines as Improved and Not Improved are reported.
COMPLETED
PHASE4
53 participants
Baseline (Day 1) to Day 45
2019-02-15
Participant Flow
Participant milestones
| Measure |
Juvéderm® VOLIFT®™ With Lidocaine
Juvéderm® VOLIFT®™ (hyaluronic acid) with Lidocaine was injected into the dynamic radial cheek line skin depressions on Day 1; volume was determined by the investigator. If applicable, a touch-up of Juvéderm® VOLIFT®™ with Lidocaine was injected on Day 14.
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Overall Study
STARTED
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53
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Overall Study
COMPLETED
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52
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
Juvéderm® VOLIFT®™ With Lidocaine
Juvéderm® VOLIFT®™ (hyaluronic acid) with Lidocaine was injected into the dynamic radial cheek line skin depressions on Day 1; volume was determined by the investigator. If applicable, a touch-up of Juvéderm® VOLIFT®™ with Lidocaine was injected on Day 14.
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Overall Study
Lost to Follow-up
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1
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Baseline Characteristics
A Study to Evaluate the Effectiveness of Juvéderm® VOLIFT®™ With Lidocaine for Dynamic Radial Cheek Line Skin Depressions
Baseline characteristics by cohort
| Measure |
Juvéderm® VOLIFT®™ With Lidocaine
n=53 Participants
Juvéderm® VOLIFT®™ (hyaluronic acid) with Lidocaine was injected into the dynamic radial cheek line skin depressions on Day 1; volume was determined by the investigator. If applicable, a touch-up of Juvéderm® VOLIFT®™ with Lidocaine was injected on Day 14.
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Age, Continuous
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56 years
STANDARD_DEVIATION 7 • n=5 Participants
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Sex: Female, Male
Female
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53 Participants
n=5 Participants
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Sex: Female, Male
Male
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0 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Baseline (Day 1) to Day 45Population: Per Protocol Population included all participants with no major protocol deviations.
Participants graded the improvement of their dynamic radial cheek lines using the GAIS 5-point scale where -2=much worse to +2=much improved. Participants who rated their improvement as -2, -1, or 0 (much worse, worse, or no change, respectively) were grouped as Not Improved and those who rated their improvement as +1 or +2 (improved or much improved, respectively) were grouped as Improved. The percentages of participants who rated their cheek lines as Improved and Not Improved are reported.
Outcome measures
| Measure |
Juvéderm® VOLIFT®™ With Lidocaine
n=52 Participants
Juvéderm® VOLIFT®™ (hyaluronic acid) with Lidocaine was injected into the dynamic radial cheek line skin depressions on Day 1; volume was determined by the investigator. If applicable, a touch-up of Juvéderm® VOLIFT®™ with Lidocaine was injected on Day 14.
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Percentage of Participants by Improvement Rating (Improved and Not Improved) of Their Dynamic Radial Cheek Lines as Assessed by the Participant Using the Global Aesthetic Improvement Scale (GAIS)
Improved
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98.1 percentage of participants
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Percentage of Participants by Improvement Rating (Improved and Not Improved) of Their Dynamic Radial Cheek Lines as Assessed by the Participant Using the Global Aesthetic Improvement Scale (GAIS)
Not Improved
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1.9 percentage of participants
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SECONDARY outcome
Timeframe: Baseline (Day 1) to Day 45Population: Safety Population included all participants who used the test product at least one time. Number analyzed is the number of participants with available data at the given time-point.
The DERMATOP® is a fringe projection system used to measure wrinkles. The system collects 2-dimensional (2D) and 3-dimensional (3D) images and then calculates the roughness, texture, and amplitude of wrinkles. To ensure that repeat measurements are made in the same area, the angles of the camera were recorded, and a red positioning laser was used to mark the edge of the chin. In addition, a 2D picture of the baseline measurements was taken by the machine to position subsequent measurements. Measurements are presented in micrometers (μm). A negative change from Baseline (pre-treatment) indicates that the roughness of wrinkles decreased.
Outcome measures
| Measure |
Juvéderm® VOLIFT®™ With Lidocaine
n=53 Participants
Juvéderm® VOLIFT®™ (hyaluronic acid) with Lidocaine was injected into the dynamic radial cheek line skin depressions on Day 1; volume was determined by the investigator. If applicable, a touch-up of Juvéderm® VOLIFT®™ with Lidocaine was injected on Day 14.
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Change From Baseline in Mean Roughness (Ra) of the Radial Cheek Lines at Maximum Smile as Assessed by DERMATOP®
Baseline (Day 1)
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96.6 μm
Standard Deviation 53.6
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Change From Baseline in Mean Roughness (Ra) of the Radial Cheek Lines at Maximum Smile as Assessed by DERMATOP®
Change from Baseline at Day 45
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-24.8 μm
Standard Deviation 31.9
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SECONDARY outcome
Timeframe: Baseline (Day 1) to Day 45Population: Safety Population included all participants who used the test product at least once. Number analyzed is the number of participants with available data at the given time-point.
The DERMATOP® is a fringe projection system used to measure wrinkles. The system collects 2-dimensional (2D) and 3-dimensional (3D) images and then calculates the roughness, texture, and amplitude of wrinkles. To ensure that repeat measurements are made in the same area, the angles of the camera were recorded, and a red positioning laser was used to mark the edge of the chin. In addition, a 2D picture of the baseline measurements was taken by the machine to position subsequent measurements. Measurements are presented in micrometers. A negative change from Baseline (pre-treatment) indicates that the texture of wrinkles improved.
Outcome measures
| Measure |
Juvéderm® VOLIFT®™ With Lidocaine
n=53 Participants
Juvéderm® VOLIFT®™ (hyaluronic acid) with Lidocaine was injected into the dynamic radial cheek line skin depressions on Day 1; volume was determined by the investigator. If applicable, a touch-up of Juvéderm® VOLIFT®™ with Lidocaine was injected on Day 14.
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Change From Baseline in Mean Texture (Rz) of the Radial Cheek Lines at Maximum Smile as Assessed by DERMATOP®
Baseline (Day 1)
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203.1 μm
Standard Deviation 72.3
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Change From Baseline in Mean Texture (Rz) of the Radial Cheek Lines at Maximum Smile as Assessed by DERMATOP®
Change from Baseline at Day 45
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-35.3 μm
Standard Deviation 43.6
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SECONDARY outcome
Timeframe: Baseline (Day 1) to Day 45Population: Safety Population included all participants who used the test product at least once. Number analyzed is the number of participants with available data at the given time-point.
The DERMATOP® is a fringe projection system used to measure wrinkles. The system collects 2-dimensional (2D) and 3-dimensional (3D) images and then calculates the roughness, texture, and amplitude of wrinkles. To ensure that repeat measurements are made in the same area, the angles of the camera were recorded, and a red positioning laser was used to mark the edge of the chin. In addition, a 2D picture of the baseline measurements was taken by the machine to position subsequent measurements. Measurements are presented in micrometers. A negative change from Baseline (pre-treatment) indicates that the amplitude of wrinkles decreased.
Outcome measures
| Measure |
Juvéderm® VOLIFT®™ With Lidocaine
n=53 Participants
Juvéderm® VOLIFT®™ (hyaluronic acid) with Lidocaine was injected into the dynamic radial cheek line skin depressions on Day 1; volume was determined by the investigator. If applicable, a touch-up of Juvéderm® VOLIFT®™ with Lidocaine was injected on Day 14.
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Change From Baseline in Mean Amplitude (Rt) of the Radial Cheek Lines at Maximum Smile as Assessed by DERMATOP®
Baseline (Day 1)
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511.8 μm
Standard Deviation 217.8
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Change From Baseline in Mean Amplitude (Rt) of the Radial Cheek Lines at Maximum Smile as Assessed by DERMATOP®
Change from Baseline at Day 45
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-115.1 μm
Standard Deviation 129.4
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SECONDARY outcome
Timeframe: Baseline (Day 1) to Day 45Population: No data was collected because wrinkle volume was not applicable.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day 1) to Day 45Population: Per Protocol Population included all participants with no major protocol deviations.
The investigator graded the improvement of the participant's dynamic radial cheek lines on both sides of their face using the 5-point GAIS where -2=much worse to +2=much improved. Responders are participants with a score of +1 or +2 (improved or much improved, respectively) on both sides; partial responder are participants with a score of +1 or +2 on only one side; and no-responders are participants with a score lower or equal to 0 on both sides. The percentages of responders, partial responders, and no-responders are reported.
Outcome measures
| Measure |
Juvéderm® VOLIFT®™ With Lidocaine
n=52 Participants
Juvéderm® VOLIFT®™ (hyaluronic acid) with Lidocaine was injected into the dynamic radial cheek line skin depressions on Day 1; volume was determined by the investigator. If applicable, a touch-up of Juvéderm® VOLIFT®™ with Lidocaine was injected on Day 14.
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Percentage of Participants by Improvement Rating (Response) of the Participants' Dynamic Radial Cheek Lines as Assessed by the Investigator Using the GAIS
Responder
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94.2 percentage of participants
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Percentage of Participants by Improvement Rating (Response) of the Participants' Dynamic Radial Cheek Lines as Assessed by the Investigator Using the GAIS
Partial Responder
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1.9 percentage of participants
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Percentage of Participants by Improvement Rating (Response) of the Participants' Dynamic Radial Cheek Lines as Assessed by the Investigator Using the GAIS
No Responder
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3.8 percentage of participants
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SECONDARY outcome
Timeframe: Baseline (Day 1) to Day 45Population: Safety Population included all participants who used the test product at least one time. Number analyzed is the number of participants with available data at the given time-point.
The SPA questionnaire consists of one question: "How do you think your facial appearance looks compared to your age TODAY?" Participants could choose one of three possible answers: "I look my current age," "I look younger," or "I look older." The percentage of participants in the following SPA categories is reported: I look my current age, I look younger and I look older.
Outcome measures
| Measure |
Juvéderm® VOLIFT®™ With Lidocaine
n=53 Participants
Juvéderm® VOLIFT®™ (hyaluronic acid) with Lidocaine was injected into the dynamic radial cheek line skin depressions on Day 1; volume was determined by the investigator. If applicable, a touch-up of Juvéderm® VOLIFT®™ with Lidocaine was injected on Day 14.
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Percentage of Participants by Self-Perceived Age Category as Assessed by the Self-Perception of Age (SPA) Questionnaire
Baseline (Day) 1: I look my current age
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53 percentage of participants
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Percentage of Participants by Self-Perceived Age Category as Assessed by the Self-Perception of Age (SPA) Questionnaire
Baseline (Day) 1: I look younger
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28 percentage of participants
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Percentage of Participants by Self-Perceived Age Category as Assessed by the Self-Perception of Age (SPA) Questionnaire
Baseline (Day) 1: I look older
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19 percentage of participants
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Percentage of Participants by Self-Perceived Age Category as Assessed by the Self-Perception of Age (SPA) Questionnaire
Day 45: I look my current age
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38 percentage of participants
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Percentage of Participants by Self-Perceived Age Category as Assessed by the Self-Perception of Age (SPA) Questionnaire
Day 45: I look younger
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60 percentage of participants
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Percentage of Participants by Self-Perceived Age Category as Assessed by the Self-Perception of Age (SPA) Questionnaire
Day 45: I look older
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2 percentage of participants
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SECONDARY outcome
Timeframe: Day 45Population: Per Protocol Population included all participants with no major protocol deviations.
Participants were asked to indicate their level agreement with the following statement: "The treatment of my smile lines gave me a natural look." Responses were scored from 0 to 10, where 0=not at all to 10=very much.
Outcome measures
| Measure |
Juvéderm® VOLIFT®™ With Lidocaine
n=52 Participants
Juvéderm® VOLIFT®™ (hyaluronic acid) with Lidocaine was injected into the dynamic radial cheek line skin depressions on Day 1; volume was determined by the investigator. If applicable, a touch-up of Juvéderm® VOLIFT®™ with Lidocaine was injected on Day 14.
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Mean Score for the Level of Naturalness of the Appearance of Participants' Dynamic Radial Cheek Lines as Assessed by a Participant Questionnaire
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7.2 units on a scale
Standard Deviation 2.2
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Adverse Events
Juvéderm® VOLIFT®™ With Lidocaine
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Juvéderm® VOLIFT®™ With Lidocaine
n=53 participants at risk
Juvéderm® VOLIFT®™ (hyaluronic acid) with Lidocaine was injected into the dynamic radial cheek line skin depressions on Day 1; volume was determined by the investigator. If applicable, a touch-up of Juvéderm® VOLIFT®™ with Lidocaine was injected on Day 14.
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General disorders
Injection site bruising
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24.5%
13/53 • Up to 59 Days after the First Injection
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General disorders
Injection site haematoma
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30.2%
16/53 • Up to 59 Days after the First Injection
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General disorders
Injection site mass
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22.6%
12/53 • Up to 59 Days after the First Injection
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER