Cheek Line Depressions
Conditions
Brief summary
This study will evaluate the effectiveness of Juvéderm® VOLIFT®™ with Lidocaine for dynamic radial cheek line skin depressions.
Interventions
DEVICEJuvéderm® 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.
Sponsors
Allergan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Presence of dynamic radial cheek lines * Agrees not to make any changes to skin care routines, or to have any facial procedures or treatments during the study
Exclusion criteria
* Previous facial surgery, tissue grafting, or tissue augmentation with silicone, fat, or other permanent, or semi-permanent dermal fillers or be planning to undergo any of these procedures during the study * Undergone temporary facial dermal filler injections with any substance in the face in the 12 months prior to study entry * Received botulinum toxin therapy of any serotype in any facial area within the previous 6 months agrees not to receive it during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Baseline (Day 1) to Day 45 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean Texture (Rz) of the Radial Cheek Lines at Maximum Smile as Assessed by DERMATOP® | Baseline (Day 1) to Day 45 | 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. |
| Change From Baseline in Mean Amplitude (Rt) of the Radial Cheek Lines at Maximum Smile as Assessed by DERMATOP® | Baseline (Day 1) to Day 45 | 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. |
| Change From Baseline in Wrinkle Volume of Radial Cheek Lines at Maximum Smile | 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® | Baseline (Day 1) to Day 45 | 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. |
| Percentage of Participants by Self-Perceived Age Category as Assessed by the Self-Perception of Age (SPA) Questionnaire | Baseline (Day 1) to Day 45 | 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. |
| Mean Score for the Level of Naturalness of the Appearance of Participants' Dynamic Radial Cheek Lines as Assessed by a Participant Questionnaire | Day 45 | 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. |
| Percentage of Participants by Improvement Rating (Response) of the Participants' Dynamic Radial Cheek Lines as Assessed by the Investigator Using the GAIS | Baseline (Day 1) to Day 45 | 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. |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 53 |
| Total | 53 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Juvéderm® VOLIFT®™ With Lidocaine |
|---|---|
| Age, Continuous | 56 years STANDARD_DEVIATION 7 |
| Sex: Female, Male Female | 53 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 31 / 53 |
| serious Total, serious adverse events | 0 / 53 |
Outcome results
Primary
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
Population: Per Protocol Population included all participants with no major protocol deviations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Juvéderm® VOLIFT®™ With Lidocaine | 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 | 98.1 percentage of participants |
| Juvéderm® VOLIFT®™ With Lidocaine | 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 | 1.9 percentage of participants |
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Juvéderm® VOLIFT®™ With Lidocaine | Change From Baseline in Mean Amplitude (Rt) of the Radial Cheek Lines at Maximum Smile as Assessed by DERMATOP® | Baseline (Day 1) | 511.8 μm | Standard Deviation 217.8 |
| Juvéderm® VOLIFT®™ With Lidocaine | 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 | -115.1 μm | Standard Deviation 129.4 |
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Juvéderm® VOLIFT®™ With Lidocaine | Change From Baseline in Mean Roughness (Ra) of the Radial Cheek Lines at Maximum Smile as Assessed by DERMATOP® | Baseline (Day 1) | 96.6 μm | Standard Deviation 53.6 |
| Juvéderm® VOLIFT®™ With Lidocaine | 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 | -24.8 μm | Standard Deviation 31.9 |
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Juvéderm® VOLIFT®™ With Lidocaine | Change From Baseline in Mean Texture (Rz) of the Radial Cheek Lines at Maximum Smile as Assessed by DERMATOP® | Baseline (Day 1) | 203.1 μm | Standard Deviation 72.3 |
| Juvéderm® VOLIFT®™ With Lidocaine | 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 | -35.3 μm | Standard Deviation 43.6 |
Secondary
Change From Baseline in Wrinkle Volume of Radial Cheek Lines at Maximum Smile
Time frame: Baseline (Day 1) to Day 45
Population: No data was collected because wrinkle volume was not applicable.
Secondary
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
Population: Per Protocol Population included all participants with no major protocol deviations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 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 units on a scale | Standard Deviation 2.2 |
Secondary
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
Population: Per Protocol Population included all participants with no major protocol deviations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Juvéderm® VOLIFT®™ With Lidocaine | Percentage of Participants by Improvement Rating (Response) of the Participants' Dynamic Radial Cheek Lines as Assessed by the Investigator Using the GAIS | Responder | 94.2 percentage of participants |
| Juvéderm® VOLIFT®™ With Lidocaine | Percentage of Participants by Improvement Rating (Response) of the Participants' Dynamic Radial Cheek Lines as Assessed by the Investigator Using the GAIS | Partial Responder | 1.9 percentage of participants |
| Juvéderm® VOLIFT®™ With Lidocaine | Percentage of Participants by Improvement Rating (Response) of the Participants' Dynamic Radial Cheek Lines as Assessed by the Investigator Using the GAIS | No Responder | 3.8 percentage of participants |
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Juvéderm® VOLIFT®™ With Lidocaine | 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 | 53 percentage of participants |
| Juvéderm® VOLIFT®™ With Lidocaine | Percentage of Participants by Self-Perceived Age Category as Assessed by the Self-Perception of Age (SPA) Questionnaire | Baseline (Day) 1: I look younger | 28 percentage of participants |
| Juvéderm® VOLIFT®™ With Lidocaine | Percentage of Participants by Self-Perceived Age Category as Assessed by the Self-Perception of Age (SPA) Questionnaire | Baseline (Day) 1: I look older | 19 percentage of participants |
| Juvéderm® VOLIFT®™ With Lidocaine | 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 | 38 percentage of participants |
| Juvéderm® VOLIFT®™ With Lidocaine | Percentage of Participants by Self-Perceived Age Category as Assessed by the Self-Perception of Age (SPA) Questionnaire | Day 45: I look younger | 60 percentage of participants |
| Juvéderm® VOLIFT®™ With Lidocaine | Percentage of Participants by Self-Perceived Age Category as Assessed by the Self-Perception of Age (SPA) Questionnaire | Day 45: I look older | 2 percentage of participants |