A Phase 4 interventional study of Juvéderm® VOLIFT®™ with Lidocaine in Cheek Line Depressions, sponsored by Allergan. Completed at 1 site in France. Open to female participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-02-15.
Sponsored by Allergan · Phase 4, Interventional, and Treatment
This study will evaluate the effectiveness of Juvéderm® VOLIFT®™ with Lidocaine for dynamic radial cheek line skin depressions.
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Exclusion Criteria:
Juvéderm® VOLIFT®™ (hyaluronic acid) with Lidocaine was injected into the dynamic radial cheek line skin depressions on Day 1; volume of injection was determined by the investigator. If applicable, a touch-up of Juvéderm® VOLIFT®™ with Lidocaine was injected on Day 14.
Device: Juvéderm® VOLIFT®™ with Lidocaine
Juvéderm® VOLIFT®™ (hyaluronic acid) with Lidocaine is injected into the dynamic radial cheek line skin depressions on Day 1; volume of injection will not exceed 2 mL per side. If applicable, a touch-up of Juvéderm® VOLIFT®™ with Lidocaine will be injected on Day 14; volume will not exceed 1 mL per side.
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)
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.
Time frame: Baseline (Day 1) to Day 45
Change From Baseline in Mean Roughness (Ra) of the Radial Cheek Lines at Maximum Smile as Assessed by DERMATOP®
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.
Time frame: Baseline (Day 1) to Day 45
Change From Baseline in Mean Texture (Rz) of the Radial Cheek Lines at Maximum Smile as Assessed by DERMATOP®
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.
Time frame: Baseline (Day 1) to Day 45
Change From Baseline in Mean Amplitude (Rt) of the Radial Cheek Lines at Maximum Smile as Assessed by DERMATOP®
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.
Time frame: Baseline (Day 1) to Day 45
Change From Baseline in Wrinkle Volume of Radial Cheek Lines at Maximum Smile
Time frame: Baseline (Day 1) to Day 45
Percentage of Participants by Improvement Rating (Response) of the Participants' Dynamic Radial Cheek Lines as Assessed by the Investigator Using the GAIS
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.
Time frame: Baseline (Day 1) to Day 45
Percentage of Participants by Self-Perceived Age Category as Assessed by the Self-Perception of Age (SPA) Questionnaire
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.
Time frame: Baseline (Day 1) to Day 45
Mean Score for the Level of Naturalness of the Appearance of Participants' Dynamic Radial Cheek Lines as Assessed by a Participant Questionnaire
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.
Time frame: Day 45
| Milestone | Juvéderm® VOLIFT®™ With Lidocaine |
|---|---|
| Started | 53 |
| Completed | 52 |
| Not completed | 1 |
| Withdrew: Lost to follow-up | 1 |
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.
| percentage of participants | Juvéderm® VOLIFT®™ With Lidocaine |
|---|---|
| Improved | 98.1 |
| Not Improved | 1.9 |
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.
| μm | Juvéderm® VOLIFT®™ With Lidocaine |
|---|---|
| Baseline (Day 1) | 96.6 ± 53.6 |
| Change from Baseline at Day 45 | -24.8 ± 31.9 |
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.
| μm | Juvéderm® VOLIFT®™ With Lidocaine |
|---|---|
| Baseline (Day 1) | 203.1 ± 72.3 |
| Change from Baseline at Day 45 | -35.3 ± 43.6 |
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.
| μm | Juvéderm® VOLIFT®™ With Lidocaine |
|---|---|
| Baseline (Day 1) | 511.8 ± 217.8 |
| Change from Baseline at Day 45 | -115.1 ± 129.4 |
No measurements were reported for this outcome.
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.
| percentage of participants | Juvéderm® VOLIFT®™ With Lidocaine |
|---|---|
| Responder | 94.2 |
| Partial Responder | 1.9 |
| No Responder | 3.8 |
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.
| percentage of participants | Juvéderm® VOLIFT®™ With Lidocaine |
|---|---|
| Baseline (Day) 1: I look my current age | 53 |
| Baseline (Day) 1: I look younger | 28 |
| Baseline (Day) 1: I look older | 19 |
| Day 45: I look my current age | 38 |
| Day 45: I look younger | 60 |
| Day 45: I look older | 2 |
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.
| units on a scale | Juvéderm® VOLIFT®™ With Lidocaine |
|---|---|
| Mean Score for the Level of Naturalness of the Appearance of Participants' Dynamic Radial Cheek Lines as Assessed by a Participant Questionnaire | 7.2 ± 2.2 |
Collected over Up to 59 Days after the First Injection. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Juvéderm® VOLIFT®™ With Lidocaine | — | 0/53 (0%) | 31/53 (58.5%) |
| Event | Juvéderm® VOLIFT®™ With Lidocaine |
|---|---|
| Injection site haematomaGeneral disorders | 16/53 |
| Injection site bruisingGeneral disorders | 13/53 |
| Injection site massGeneral disorders | 12/53 |
Safety Population included all participants who were treated with test product at least once.
| Age, Continuous(years) | Juvéderm® VOLIFT®™ With Lidocaine |
|---|---|
| Mean | 56 ± 7 |
| Sex: Female, Male(Participants) | Juvéderm® VOLIFT®™ With Lidocaine |
|---|---|
| Female | 53 |
| Male | 0 |
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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