Healthy Adults, Skin Enhancement
Conditions
Brief summary
To evaluate the impact on skin quality attributes, including physical measurements and gene and protein expression (histological and genomic analysis), following administration of Juvéderm® VOLITE in the volar forearms of healthy volunteers.
Interventions
DEVICEJuvederm® VOLITE
1 mL of Juvéderm® VOLITE contains hyaluronic acid gel 12.0 milligram (mg), lidocaine hydrochloride 3.0 mg in a phosphate buffer pH 7.2 q.s. 1 mL (or gram).
Sponsors
Allergan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy participants * Participants with Fitzpatrick skin type II or III * Participant willing to receive Juvéderm® VOLITE in the forearms and agrees to complete all study required procedures, including having 6 cutaneous punch biopsies taken in the forearms and blood drawn (Human immunodeficiency virus \[HIV\], B and C hepatitis analysis at screening) * Written informed consent and data privacy consent obtained
Exclusion criteria
* Pregnant or nursing woman or planning a pregnancy during the study * Participant participating to another research on human beings or being in an exclusion period for a previous study * Intensive exposure to sunlight or ultraviolet (UV)-rays within the previous month and foreseen during the study * Participant having other resorbable filling product injections, a laser treatment, an ultrasound-based treatment, radiation treatment, a dermabrasion, a surgery, a deep chemical peeling or other ablative procedure on the studied zones within the past 12 months prior to study start * Participant with subcutaneous retaining structure on the studied zones (meshing, threads, gold strand) * Participant having received injections of permanent or semi-permanent filling products in the studied zones * Participant under anti-coagulant treatment or treatment liable to interfere with the healing process or hemostasis, during the previous month and during the study * Participant receiving or is planning to receive anti-inflammatory drugs (oral/injectable corticosteroids or Nonsteroidal anti-inflammatory drugs (NSAIDs), e.g., aspirin, ibuprofen), or other substances known to increase coagulation time (herbal supplements with garlic or ginkgo biloba, etc) for 10 days prior to study treatment and 3 days after * Participant under immunosuppressive therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Skin Hydration as Measured by MoistureMeterD® 0.5 mm | Baseline [Day 0 (D0)] to Days 28 (D28) and 84 (D84) | Skin hydration was measured using MoistureMeterD® XS (for epidermis and dermis), a non-invasive probe which measures the dielectric constant of the skin at a depth of 0.5 mm. 5 measurements were done on the same zone and the average value was calculated, expressed as tissue dielectric constant (TDC). The TDC is directly proportional to the amount of water in the tissue. A positive change from Baseline indicates better skin hydration. Values were obtained from a mixed analysis of variance (ANOVA) model. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants. |
| Change From Baseline in Skin Hydration as Measured by MoistureMeter D® 1.5 mm | Baseline (D0) to D28 and D84 | Skin hydration was measured using MoistureMeter D® S15 (for epidermis and dermis), a non-invasive probe which measures the dielectric constant of the skin at a depth of 1.5 mm. 5 measurements were done on the same zone and the average value was calculated, expressed as TDC. The TDC is directly proportional to the amount of water in the tissue. A positive change from Baseline indicates better skin hydration. Values were obtained from a mixed ANOVA model. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants. |
| Change From Baseline in Skin Hydration as Measured by Corneometer® | Baseline (D0) to D28 and D84 | Corneometer® measures the hydration level of the superficial skin surface (epidermis). The measurement is based on capacitance measurement of a dielectric medium in this case skin. It uses fringing field capacitance sensors to measure the dielectric constant of the skin. The dielectric constant of skin will change with water content. This allows for any changes in skin hydration to be measured by the precision measuring capacitor. These changes in water content of the stratum corneum are converted into arbitrary units of hydration. 5 measurements were done on the same zone and average value was calculated. Values were obtained from a mixed ANOVA model and expressed in arbitrary units. A positive change from Baseline indicates better skin hydration rate. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants. |
| Change From Baseline in Skin Elasticity Parameters: Uf: Final Deformation (Firmness), Ue: Immediate Extensibility, Ur: Immediate Retraction (Tonicity), Ua: Total Recovery of the Initial State as Measured by Cutometer ® | Baseline (D0) to D28 and D84 | Skin elasticity was measured by a Cutometer ® which uses an in vivo non-invasive method to evaluate biological extensibility and elasticity variations. The various parameters analysed were Uf: final deformation (firmness), Ue: immediate extensibility, Ur: immediate retraction (tonicity), Ua: total recovery of the initial state. 2 measurements were done on the same zone and the average value was calculated. Values were obtained from a mixed ANOVA model. A Negative change from Baseline indicates firmer skin. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants. |
| Change From Baseline in Relative Parameters of Skin Elasticity: Q1, Q2, Q3 as Measured by Cutometer ® | Baseline (D0) to D28 and D84 | The parameters evaluated were: Elastic Recovery (Q1)=elastic recovery area (QE)/maximum recovery area (QO), Viscous Recovery (Q2)=viscous recovery area (QR)/maximum recovery area (QO) and Viscoelastic Recovery (Q3)= (QE+QR)/QO. 2 measurements were done on the same zone and the average value was calculated. Values were obtained from a mixed ANOVA model. A negative change from Baseline in Q1 and Q2 indicates decreased skin elasticity. A positive change from Baseline in Q3 indicates decreased skin elasticity. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants. |
| Number of Participants With at Least One Treatment-emergent Adverse Event (AE) | First dose of study treatment to end of the study (Up to 9 months) | An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A treatment-emergent AE is an AE that occurs or worsens after a participant receives study drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Plexus Depth as Measured by Vivosight OCT® | Baseline (D0) to D28 and D84 | Plexus depth is a skin vascularity parameter and was measured by Vivosight OCT® system which is used to obtain high resolution imaging of skin sub-structures and vascular networks. Values were obtained from a mixed ANOVA model. A negative change from Baseline indicates decreased plexus depth. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants. |
| Change From Baseline in Vessel Diameter as Measured by Vivosight OCT® | Baseline (D0) to D28 and D84 | Vessel diameter is a skin vascularity parameter and was measured by Vivosight OCT® system which is used to obtain high resolution imaging of skin sub-structures and vascular networks. Values were obtained from a mixed ANOVA model. A positive change from Baseline indicates increased vessel diameter. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants. |
| Change From Baseline in Vessel Density as Measured by Vivosight OCT® | Baseline (D0) to D28 and D84 | Vessel density is a skin vascularity parameter and was measured by Vivosight OCT® system which is used to obtain high resolution imaging of skin sub-structures and vascular networks. A positive change from Baseline indicates increased vessel density. Values were obtained from a mixed ANOVA model. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants. |
| Change From Baseline in 300 μm Density as Measured by Vivosight OCT® | Baseline (D0) to D28 and D84 | 300 μm density is a skin vascularity parameter and was measured by Vivosight OCT® system which is used to obtain high resolution imaging of skin sub-structures and vascular networks. Values were obtained from a mixed ANOVA model. A positive change from Baseline indicates increased 300 μm density. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants. |
| Change From Baseline in Skin Elasticity as Measured by Elastimeter® | Baseline (D0) to D28 and D84 | Instant skin elasticity was measured with Elastimeter® and defines the skin elasticity determined as a resistance against deformation caused by the Elastimeter® probe on the skin surface. 3 measurements were done on the same zone and the average value was calculated. The values were expressed in Newton/meter. Higher values of ISE indicate higher skin elasticity. A positive change from Baseline indicates increased skin elasticity. Values were obtained from a mixed ANOVA model. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants. |
| Change From Baseline in Skin Colour as Measured by Spectrophotometer® | Baseline (D0) to D28 and D84 | Skin colour was measured by Spectrophotometer®. It converts colours perceived by man to a digital code composed of three parameters: L\*: for clarity (from dark to light) a\*: for the green-to-red spectrum b\*: for the blue-to-yellow spectrum; a\* and b\* are chrominance parameters, L\* is a luminance parameter. Higher values of a\*, b\*and L\* indicates 'skin more red', 'skin more yellow' and 'skin clearer'. Values were obtained from a mixed ANOVA model and expressed in arbitrary units. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants. |
| Change From Baseline in Individual Typological Angle (ITA°) as Measured by Spectrophotometer® | Baseline (D0) to D28 and D84 | Individual typological angle (ITA°), defines the skin pigmentation degree of a participant with taking into account the skin clarity (L\*) and the melanin parameter (b\*). 3 measurements were done on the same zone and the average values were calculated. Values were obtained from a mixed ANOVA model and expressed in degree (°). Higher values of ITA° indicates 'skin less pigmented'. A positive change from Baseline indicates less pigmented skin. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants. |
| Change From Baseline in Skin Melanin Index as Measured by Mexameter® | Baseline (D0) to D28 and D84 | Melanin index measured with Mexameter® defines the skin pigmentation related to melanin content in the skin. Measurements are performed by the application of a probe to the skin surface. The probe has a 5 mm aperture that emits radiations. These radiations are reflected by the skin and captured back by the same probe. The results are expressed as an index value for each parameter in arbitrary units from 0 to 999. 3 measurements were done on the same zone and the average value was calculated. Values were obtained from a mixed ANOVA model. A negative change from Baseline indicates less pigmented skin. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants. |
| Number of Participants With Injection Site Reactions (ISR) | Day 0 | ISRs are reactions that occur after injection of the study drug. The following ISRs: Redness/Erythema, Pain/Tenderness, Induration, Swelling/Oedema, Lumps/Bumps, Bruising/Hematoma, Itching, Discoloration/Pigmentation were reported as None, Mild, Moderate or Severe. Only those categories reported for at least 1 participant are reported. |
| Change From Baseline in Skin Brightness Index as Measured by Glossymeter® | Baseline (D0) to D28 and D84 | Skin brightness index was measured using Glossymeter®. 3 measurements were done on the same zone and the average value was calculated. Values were expressed in Glossymeter Units. Values were obtained from a mixed ANOVA model. Higher glossymeter values indicate higher skin brightness. A positive change from Baseline indicates increased skin brightness. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants. |
| Change From Baseline in Skin Thickness as Measured by Skin Scanner® | Baseline (D0) to D28 and D84 | Skin thickness was measured as the average thickness of the epidermis and dermis (in mm) using SkinScanner®, a high frequency echograph. Values were obtained from a mixed ANOVA model. A positive change from Baseline indicates increased skin thickness. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants. |
| Change From Baseline in Skin Density as Measured by Skin Scanner® | Baseline (D0) to D28 and D84 | Skin density was measured as the percentage of echogenic surface using SkinScanner®, a high frequency echograph. Values were obtained from a mixed ANOVA model. A positive change from Baseline indicates increased skin density. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants. |
| Change From Baseline in Skin Roughness as Measured by Vivosight OCT® | Baseline (D0) to D28 and D84 | Skin roughness was measured by Vivosight optical coherence tomography (OCT®) system which is used to obtain high resolution imaging of skin sub-structures and vascular networks. The skin roughness parameters from the images included Ra and Rz. Ra is a measure of the average length that is between peaks and valleys. Rz helps measure the vertical distance between the highest peak and the lowest valley. Values were obtained from a mixed ANOVA model. A negative change from Baseline indicates decreased skin roughness. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants. |
| Change From Baseline in Epidermal Thickness as Measured by Vivosight OCT® | Baseline (D0) to D28 and D84 | Epidermal thickness is a skin density parameter measured by Vivosight OCT® system used to obtain high resolution imaging of skin sub-structures and vascular networks. Values were obtained from a mixed ANOVA model. A positive change from Baseline indicates increased epidermal thickness. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants. |
| Change From Baseline in Optical Attenuation Coefficient (OAC) as Measured by Vivosight OCT® | Baseline (D0) to D28 and D84 | OAC is a skin density parameter measured by Vivosight OCT® system used to obtain high resolution imaging of skin sub-structures and vascular networks. It analytically describes the reduction of OCT signal intensity with increasing depth-in-tissue. Values were obtained from a mixed ANOVA model. A positive change from Baseline indicates increased skin density. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants. |
Countries
Poland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Juvéderm® VOLITE Treated Zone Participants received Juvéderm® VOLITE, intradermal injection on a zone of 8 cm x 4 cm (32 cm\^2) of the volar left forearm on Day 0. The dose to be injected was decided by the investigator as per the Directions for Use. A maximum of 1 mL was injected on the zone treated. | 11 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Consent withdrawal | 1 |
Baseline characteristics
| Characteristic | Juvéderm® VOLITE Treated Zone | — |
|---|---|---|
| 300 μm Density Juvéderm® VOLITE Treated Zone | 2.61 dimensionless STANDARD_DEVIATION 0.62 | — |
| 300 μm Density Non-Treated Zone | 2.84 dimensionless STANDARD_DEVIATION 0.7 | — |
| Age, Continuous | 40.82 years STANDARD_DEVIATION 6.1 | — |
| Epidermal Thickness (Vivosight OCT®) Juvéderm® VOLITE Treated Zone | 92.64 µm STANDARD_DEVIATION 14.93 | — |
| Epidermal Thickness (Vivosight OCT®) Non-Treated Zone | 94.58 µm STANDARD_DEVIATION 8.7 | — |
| Individual Typological Angle (ITA°) (Spectrophotometer®) Juvéderm® VOLITE Treated Zone | 40.5 degree STANDARD_DEVIATION 9.3 | — |
| Individual Typological Angle (ITA°) (Spectrophotometer®) Non-Treated Zone | 38.4 degree STANDARD_DEVIATION 8.1 | — |
| Optical Attenuation Coefficient (OAC) (Vivosight OCT®) Juvéderm® VOLITE Treated Zone | 2.61 per mm (mm^-1) STANDARD_DEVIATION 0.27 | — |
| Optical Attenuation Coefficient (OAC) (Vivosight OCT®) Non-Treated Zone | 2.71 per mm (mm^-1) STANDARD_DEVIATION 0.21 | — |
| Plexus Depth (Vivosight OCT®) Juvéderm® VOLITE Treated Zone | 332.59 µm STANDARD_DEVIATION 13.9 | — |
| Plexus Depth (Vivosight OCT®) Non-Treated Zone | 319.67 µm STANDARD_DEVIATION 17.84 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Relative Parameters of Skin Elasticity (Cutometer ®) Elastic Recovery (Q1): Juvéderm® VOLITE Treated Zone | 0.781 dimensionless STANDARD_DEVIATION 0.052 | — |
| Relative Parameters of Skin Elasticity (Cutometer ®) Elastic Recovery (Q1): Non-Treated Zone | 0.825 dimensionless STANDARD_DEVIATION 0.046 | — |
| Relative Parameters of Skin Elasticity (Cutometer ®) Viscoelastic Recovery (Q3): Juvéderm® VOLITE Treated Zone | 0.151 dimensionless STANDARD_DEVIATION 0.034 | — |
| Relative Parameters of Skin Elasticity (Cutometer ®) Viscoelastic Recovery (Q3): Non-Treated Zone | 0.109 dimensionless STANDARD_DEVIATION 0.028 | — |
| Relative Parameters of Skin Elasticity (Cutometer ®) Viscous Recovery (Q2): Juvéderm® VOLITE Treated Zone | 0.630 dimensionless STANDARD_DEVIATION 0.083 | — |
| Relative Parameters of Skin Elasticity (Cutometer ®) Viscous Recovery (Q2): Non-Treated Zone | 0.716 dimensionless STANDARD_DEVIATION 0.073 | — |
| Sex: Female, Male Female | 9 Participants | — |
| Sex: Female, Male Male | 2 Participants | — |
| Skin Brightness Index Juvéderm® VOLITE Treated Zone | 6.3 glossymeter units STANDARD_DEVIATION 1.1 | — |
| Skin Brightness Index Non-Treated Zone | 5.7 glossymeter units STANDARD_DEVIATION 0.8 | — |
| Skin Colour (Spectrophotometer®) a*: Juvéderm® VOLITE Treated Zone | 6.3 arbitrary units STANDARD_DEVIATION 2 | — |
| Skin Colour (Spectrophotometer®) a*: Non-Treated Zone | 7.0 arbitrary units STANDARD_DEVIATION 1.5 | — |
| Skin Colour (Spectrophotometer®) b*: Juvéderm® VOLITE Treated Zone | 17.2 arbitrary units STANDARD_DEVIATION 2.7 | — |
| Skin Colour (Spectrophotometer®) b*: Non-Treated Zone | 17.8 arbitrary units STANDARD_DEVIATION 2.3 | — |
| Skin Colour (Spectrophotometer®) L*: Juvéderm® VOLITE Treated Zone | 64.7 arbitrary units STANDARD_DEVIATION 2.8 | — |
| Skin Colour (Spectrophotometer®) L*: Non-Treated Zone | 64.1 arbitrary units STANDARD_DEVIATION 2.5 | — |
| Skin Density (Skin Scanner®) Juvéderm® VOLITE Treated Zone | 33.63 percentage of echogenic surface STANDARD_DEVIATION 5.29 | — |
| Skin Density (Skin Scanner®) Non-Treated Zone | 44.05 percentage of echogenic surface STANDARD_DEVIATION 7.05 | — |
| Skin Elasticity Juvéderm® VOLITE Treated Zone | 40.91 Newton/meter STANDARD_DEVIATION 10.27 | — |
| Skin Elasticity Non-Treated Zone | 38.55 Newton/meter STANDARD_DEVIATION 11.49 | — |
| Skin Elasticity Parameters (Cutometer ®) Ua: Juvéderm® VOLITE Treated Zone | 0.844 millimeters (mm) STANDARD_DEVIATION 0.125 | — |
| Skin Elasticity Parameters (Cutometer ®) Ua: Non-Treated Zone | 0.916 millimeters (mm) STANDARD_DEVIATION 0.131 | — |
| Skin Elasticity Parameters (Cutometer ®) Ue: Juvéderm® VOLITE Treated Zone | 0.816 millimeters (mm) STANDARD_DEVIATION 0.1 | — |
| Skin Elasticity Parameters (Cutometer ®) Ue: Non-Treated Zone | 0.864 millimeters (mm) STANDARD_DEVIATION 0.115 | — |
| Skin Elasticity Parameters (Cutometer ®) Uf: Juvéderm® VOLITE Treated Zone | 0.989 millimeters (mm) STANDARD_DEVIATION 0.109 | — |
| Skin Elasticity Parameters (Cutometer ®) Uf: Non-Treated Zone | 1.041 millimeters (mm) STANDARD_DEVIATION 0.127 | — |
| Skin Elasticity Parameters (Cutometer ®) Ur: Juvéderm® VOLITE Treated Zone | 0.660 millimeters (mm) STANDARD_DEVIATION 0.131 | — |
| Skin Elasticity Parameters (Cutometer ®) Ur: Non-Treated Zone | 0.777 millimeters (mm) STANDARD_DEVIATION 0.138 | — |
| Skin Hydration (Corneometer®) Juvéderm® VOLITE Treated Zone | 29.5 arbitrary units of hydration STANDARD_DEVIATION 5.5 | — |
| Skin Hydration (Corneometer®) Non-Treated Zone | 29.3 arbitrary units of hydration STANDARD_DEVIATION 5.5 | — |
| Skin Hydration (MoistureMeterD® S Probe) Juvéderm® VOLITE Treated Zone | 35.9 tissue dielectric constant STANDARD_DEVIATION 5.3 | — |
| Skin Hydration (MoistureMeterD® S Probe) Non-Treated Zone | 30.6 tissue dielectric constant STANDARD_DEVIATION 2.6 | — |
| Skin Hydration (MoistureMeterD® XS Probe) Juvéderm® VOLITE Treated Zone | 32.6 tissue dielectric constant STANDARD_DEVIATION 4.3 | — |
| Skin Hydration (MoistureMeterD® XS Probe) Non-Treated Zone | 35.9 tissue dielectric constant STANDARD_DEVIATION 5.3 | — |
| Skin Melanin Index (Mexameter®) Juvéderm® VOLITE Treated Zone | 150.03 arbitrary units STANDARD_DEVIATION 38.45 | — |
| Skin Melanin Index (Mexameter®) Non-Treated Zone | 181.40 arbitrary units STANDARD_DEVIATION 32.49 | — |
| Skin Roughness (Vivosight OCT®) Ra: Juvéderm® VOLITE Treated Zone | 13.81 micrometer (µm) STANDARD_DEVIATION 2.99 | — |
| Skin Roughness (Vivosight OCT®) Ra: Non-Treated Zone | 18.17 micrometer (µm) STANDARD_DEVIATION 2.16 | — |
| Skin Roughness (Vivosight OCT®) Rz: Juvéderm® VOLITE Treated Zone | 89.50 micrometer (µm) STANDARD_DEVIATION 16.63 | — |
| Skin Roughness (Vivosight OCT®) Rz: Non-Treated Zone | 111.73 micrometer (µm) STANDARD_DEVIATION 10.63 | — |
| Skin Thickness (Skin Scanner®) Juvéderm® VOLITE Treated Zone | 1246 mm STANDARD_DEVIATION 160 | — |
| Skin Thickness (Skin Scanner®) Non-Treated Zone | 1064 mm STANDARD_DEVIATION 121 | — |
| Vessel Density Juvéderm® VOLITE Treated Zone | 1.98 dimensionless STANDARD_DEVIATION 0.98 | — |
| Vessel Density Non-Treated Zone | 2.24 dimensionless STANDARD_DEVIATION 1.05 | — |
| Vessel Diameter (Vivosight OCT®) Juvéderm® VOLITE Treated Zone | 44.13 µm STANDARD_DEVIATION 8.12 | — |
| Vessel Diameter (Vivosight OCT®) Non-Treated Zone | 46.64 µm STANDARD_DEVIATION 8.6 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 11 |
| other Total, other adverse events | 5 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
Primary
Change From Baseline in Relative Parameters of Skin Elasticity: Q1, Q2, Q3 as Measured by Cutometer ®
The parameters evaluated were: Elastic Recovery (Q1)=elastic recovery area (QE)/maximum recovery area (QO), Viscous Recovery (Q2)=viscous recovery area (QR)/maximum recovery area (QO) and Viscoelastic Recovery (Q3)= (QE+QR)/QO. 2 measurements were done on the same zone and the average value was calculated. Values were obtained from a mixed ANOVA model. A negative change from Baseline in Q1 and Q2 indicates decreased skin elasticity. A positive change from Baseline in Q3 indicates decreased skin elasticity. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.
Time frame: Baseline (D0) to D28 and D84
Population: FAS included any participant included in the study with at least a post-baseline value. Number analyzed is the number of participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Juvéderm® VOLITE Treated Zone | Change From Baseline in Relative Parameters of Skin Elasticity: Q1, Q2, Q3 as Measured by Cutometer ® | Q1: Change from Baseline to Day 28 | -0.025 dimensionless | Standard Error 0.015 |
| Juvéderm® VOLITE Treated Zone | Change From Baseline in Relative Parameters of Skin Elasticity: Q1, Q2, Q3 as Measured by Cutometer ® | Q1: Change from Baseline to Day 84 | -0.042 dimensionless | Standard Error 0.012 |
| Juvéderm® VOLITE Treated Zone | Change From Baseline in Relative Parameters of Skin Elasticity: Q1, Q2, Q3 as Measured by Cutometer ® | Q2: Change from Baseline to Day 28 | -0.045 dimensionless | Standard Error 0.017 |
| Juvéderm® VOLITE Treated Zone | Change From Baseline in Relative Parameters of Skin Elasticity: Q1, Q2, Q3 as Measured by Cutometer ® | Q2: Change from Baseline to Day 84 | -0.053 dimensionless | Standard Error 0.014 |
| Juvéderm® VOLITE Treated Zone | Change From Baseline in Relative Parameters of Skin Elasticity: Q1, Q2, Q3 as Measured by Cutometer ® | Q3: Change from Baseline to Day 28 | 0.019 dimensionless | Standard Error 0.006 |
| Juvéderm® VOLITE Treated Zone | Change From Baseline in Relative Parameters of Skin Elasticity: Q1, Q2, Q3 as Measured by Cutometer ® | Q3: Change from Baseline to Day 84 | 0.013 dimensionless | Standard Error 0.005 |
| Non-Treated Zone | Change From Baseline in Relative Parameters of Skin Elasticity: Q1, Q2, Q3 as Measured by Cutometer ® | Q3: Change from Baseline to Day 28 | 0.006 dimensionless | Standard Error 0.007 |
| Non-Treated Zone | Change From Baseline in Relative Parameters of Skin Elasticity: Q1, Q2, Q3 as Measured by Cutometer ® | Q1: Change from Baseline to Day 28 | -0.017 dimensionless | Standard Error 0.013 |
| Non-Treated Zone | Change From Baseline in Relative Parameters of Skin Elasticity: Q1, Q2, Q3 as Measured by Cutometer ® | Q2: Change from Baseline to Day 84 | -0.019 dimensionless | Standard Error 0.015 |
| Non-Treated Zone | Change From Baseline in Relative Parameters of Skin Elasticity: Q1, Q2, Q3 as Measured by Cutometer ® | Q1: Change from Baseline to Day 84 | -0.018 dimensionless | Standard Error 0.011 |
| Non-Treated Zone | Change From Baseline in Relative Parameters of Skin Elasticity: Q1, Q2, Q3 as Measured by Cutometer ® | Q3: Change from Baseline to Day 84 | 0.001 dimensionless | Standard Error 0.006 |
| Non-Treated Zone | Change From Baseline in Relative Parameters of Skin Elasticity: Q1, Q2, Q3 as Measured by Cutometer ® | Q2: Change from Baseline to Day 28 | -0.023 dimensionless | Standard Error 0.018 |
Comparison: Q1: Change from Baseline to Day 28p-value: 0.578695% CI: [-0.038, 0.022]Mixed ANOVA
Comparison: Q1: Change from Baseline to Day 84p-value: 0.06995% CI: [-0.049, 0.002]Mixed ANOVA
Comparison: Q2: Change from Baseline to Day 28p-value: 0.193495% CI: [-0.054, 0.012]Mixed ANOVA
Comparison: Q2: Change from Baseline to Day 84p-value: 0.019495% CI: [-0.062, -0.006]Mixed ANOVA
Comparison: Q3: Change from Baseline to Day 28p-value: 0.065295% CI: [-0.001, 0.028]Mixed ANOVA
Comparison: Q3: Change from Baseline to Day 84p-value: 0.075695% CI: [-0.001, 0.024]Mixed ANOVA
Primary
Change From Baseline in Skin Elasticity Parameters: Uf: Final Deformation (Firmness), Ue: Immediate Extensibility, Ur: Immediate Retraction (Tonicity), Ua: Total Recovery of the Initial State as Measured by Cutometer ®
Skin elasticity was measured by a Cutometer ® which uses an in vivo non-invasive method to evaluate biological extensibility and elasticity variations. The various parameters analysed were Uf: final deformation (firmness), Ue: immediate extensibility, Ur: immediate retraction (tonicity), Ua: total recovery of the initial state. 2 measurements were done on the same zone and the average value was calculated. Values were obtained from a mixed ANOVA model. A Negative change from Baseline indicates firmer skin. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.
Time frame: Baseline (D0) to D28 and D84
Population: FAS included any participant included in the study with at least a post-baseline value. Number analyzed is the number of participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Juvéderm® VOLITE Treated Zone | Change From Baseline in Skin Elasticity Parameters: Uf: Final Deformation (Firmness), Ue: Immediate Extensibility, Ur: Immediate Retraction (Tonicity), Ua: Total Recovery of the Initial State as Measured by Cutometer ® | Uf: Change from Baseline to Day 28 | -0.092 mm | Standard Error 0.009 |
| Juvéderm® VOLITE Treated Zone | Change From Baseline in Skin Elasticity Parameters: Uf: Final Deformation (Firmness), Ue: Immediate Extensibility, Ur: Immediate Retraction (Tonicity), Ua: Total Recovery of the Initial State as Measured by Cutometer ® | Uf: Change from Baseline to Day 84 | -0.073 mm | Standard Error 0.009 |
| Juvéderm® VOLITE Treated Zone | Change From Baseline in Skin Elasticity Parameters: Uf: Final Deformation (Firmness), Ue: Immediate Extensibility, Ur: Immediate Retraction (Tonicity), Ua: Total Recovery of the Initial State as Measured by Cutometer ® | Ue: Change from Baseline to Day 28 | -0.094 mm | Standard Error 0.01 |
| Juvéderm® VOLITE Treated Zone | Change From Baseline in Skin Elasticity Parameters: Uf: Final Deformation (Firmness), Ue: Immediate Extensibility, Ur: Immediate Retraction (Tonicity), Ua: Total Recovery of the Initial State as Measured by Cutometer ® | Ue: Change from Baseline to Day 84 | -0.075 mm | Standard Error 0.008 |
| Juvéderm® VOLITE Treated Zone | Change From Baseline in Skin Elasticity Parameters: Uf: Final Deformation (Firmness), Ue: Immediate Extensibility, Ur: Immediate Retraction (Tonicity), Ua: Total Recovery of the Initial State as Measured by Cutometer ® | Ur: Change from Baseline to Day 28 | -0.097 mm | Standard Error 0.015 |
| Juvéderm® VOLITE Treated Zone | Change From Baseline in Skin Elasticity Parameters: Uf: Final Deformation (Firmness), Ue: Immediate Extensibility, Ur: Immediate Retraction (Tonicity), Ua: Total Recovery of the Initial State as Measured by Cutometer ® | Ur: Change from Baseline to Day 84 | -0.096 mm | Standard Error 0.012 |
| Juvéderm® VOLITE Treated Zone | Change From Baseline in Skin Elasticity Parameters: Uf: Final Deformation (Firmness), Ue: Immediate Extensibility, Ur: Immediate Retraction (Tonicity), Ua: Total Recovery of the Initial State as Measured by Cutometer ® | Ua: Change from Baseline to Day 28 | -0.090 mm | Standard Error 0.015 |
| Juvéderm® VOLITE Treated Zone | Change From Baseline in Skin Elasticity Parameters: Uf: Final Deformation (Firmness), Ue: Immediate Extensibility, Ur: Immediate Retraction (Tonicity), Ua: Total Recovery of the Initial State as Measured by Cutometer ® | Ua: Change from Baseline to Day 84 | -0.093 mm | Standard Error 0.011 |
| Non-Treated Zone | Change From Baseline in Skin Elasticity Parameters: Uf: Final Deformation (Firmness), Ue: Immediate Extensibility, Ur: Immediate Retraction (Tonicity), Ua: Total Recovery of the Initial State as Measured by Cutometer ® | Ua: Change from Baseline to Day 84 | -0.016 mm | Standard Error 0.01 |
| Non-Treated Zone | Change From Baseline in Skin Elasticity Parameters: Uf: Final Deformation (Firmness), Ue: Immediate Extensibility, Ur: Immediate Retraction (Tonicity), Ua: Total Recovery of the Initial State as Measured by Cutometer ® | Uf: Change from Baseline to Day 28 | 0.003 mm | Standard Error 0.008 |
| Non-Treated Zone | Change From Baseline in Skin Elasticity Parameters: Uf: Final Deformation (Firmness), Ue: Immediate Extensibility, Ur: Immediate Retraction (Tonicity), Ua: Total Recovery of the Initial State as Measured by Cutometer ® | Ur: Change from Baseline to Day 28 | -0.018 mm | Standard Error 0.02 |
| Non-Treated Zone | Change From Baseline in Skin Elasticity Parameters: Uf: Final Deformation (Firmness), Ue: Immediate Extensibility, Ur: Immediate Retraction (Tonicity), Ua: Total Recovery of the Initial State as Measured by Cutometer ® | Uf: Change from Baseline to Day 84 | -0.003 mm | Standard Error 0.007 |
| Non-Treated Zone | Change From Baseline in Skin Elasticity Parameters: Uf: Final Deformation (Firmness), Ue: Immediate Extensibility, Ur: Immediate Retraction (Tonicity), Ua: Total Recovery of the Initial State as Measured by Cutometer ® | Ua: Change from Baseline to Day 28 | -0.009 mm | Standard Error 0.015 |
| Non-Treated Zone | Change From Baseline in Skin Elasticity Parameters: Uf: Final Deformation (Firmness), Ue: Immediate Extensibility, Ur: Immediate Retraction (Tonicity), Ua: Total Recovery of the Initial State as Measured by Cutometer ® | Ue: Change from Baseline to Day 28 | -0.005 mm | Standard Error 0.013 |
| Non-Treated Zone | Change From Baseline in Skin Elasticity Parameters: Uf: Final Deformation (Firmness), Ue: Immediate Extensibility, Ur: Immediate Retraction (Tonicity), Ua: Total Recovery of the Initial State as Measured by Cutometer ® | Ur: Change from Baseline to Day 84 | -0.022 mm | Standard Error 0.015 |
| Non-Treated Zone | Change From Baseline in Skin Elasticity Parameters: Uf: Final Deformation (Firmness), Ue: Immediate Extensibility, Ur: Immediate Retraction (Tonicity), Ua: Total Recovery of the Initial State as Measured by Cutometer ® | Ue: Change from Baseline to Day 84 | 0.006 mm | Standard Error 0.009 |
Comparison: Uf: Change from Baseline to Day 28p-value: <0.000195% CI: [-0.119, -0.07]Mixed ANOVA
Comparison: Uf: Change from Baseline to Day 84p-value: <0.000195% CI: [-0.094, -0.048]Mixed ANOVA
Comparison: Ue: Change from Baseline to Day 28p-value: <0.000195% CI: [-0.116, -0.061]Mixed ANOVA
Comparison: Ue: Change from Baseline to Day 84p-value: <0.000195% CI: [-0.102, -0.061]Mixed ANOVA
Comparison: Ur: Change from Baseline to Day 28p-value: 0.000395% CI: [-0.116, -0.041]Mixed ANOVA
Comparison: Ur: Change from Baseline to Day 84p-value: 0.000195% CI: [-0.103, -0.044]Mixed ANOVA
Comparison: Ua: Change from Baseline to Day 28p-value: 0.000295% CI: [-0.117, -0.045]Mixed ANOVA
Comparison: Ua: Change from Baseline to Day 84p-value: <0.000195% CI: [-0.103, -0.052]Mixed ANOVA
Primary
Change From Baseline in Skin Hydration as Measured by Corneometer®
Corneometer® measures the hydration level of the superficial skin surface (epidermis). The measurement is based on capacitance measurement of a dielectric medium in this case skin. It uses fringing field capacitance sensors to measure the dielectric constant of the skin. The dielectric constant of skin will change with water content. This allows for any changes in skin hydration to be measured by the precision measuring capacitor. These changes in water content of the stratum corneum are converted into arbitrary units of hydration. 5 measurements were done on the same zone and average value was calculated. Values were obtained from a mixed ANOVA model and expressed in arbitrary units. A positive change from Baseline indicates better skin hydration rate. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.
Time frame: Baseline (D0) to D28 and D84
Population: FAS included any participant included in the study with at least a post-baseline value. Number analyzed is the number of participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Juvéderm® VOLITE Treated Zone | Change From Baseline in Skin Hydration as Measured by Corneometer® | Change from Baseline to Day 28 | 1.3 arbitrary units of hydration | Standard Error 1.1 |
| Juvéderm® VOLITE Treated Zone | Change From Baseline in Skin Hydration as Measured by Corneometer® | Change from Baseline to Day 84 | 2.5 arbitrary units of hydration | Standard Error 1.2 |
| Non-Treated Zone | Change From Baseline in Skin Hydration as Measured by Corneometer® | Change from Baseline to Day 28 | -1.4 arbitrary units of hydration | Standard Error 1 |
| Non-Treated Zone | Change From Baseline in Skin Hydration as Measured by Corneometer® | Change from Baseline to Day 84 | 0.1 arbitrary units of hydration | Standard Error 1.2 |
Comparison: Change from Baseline to Day 28p-value: 0.000795% CI: [1.4, 4]Mixed ANOVA
Comparison: Change from Baseline to Day 84p-value: 0.003395% CI: [0.9, 3.9]Mixed ANOVA
Primary
Change From Baseline in Skin Hydration as Measured by MoistureMeterD® 0.5 mm
Skin hydration was measured using MoistureMeterD® XS (for epidermis and dermis), a non-invasive probe which measures the dielectric constant of the skin at a depth of 0.5 mm. 5 measurements were done on the same zone and the average value was calculated, expressed as tissue dielectric constant (TDC). The TDC is directly proportional to the amount of water in the tissue. A positive change from Baseline indicates better skin hydration. Values were obtained from a mixed analysis of variance (ANOVA) model. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.
Time frame: Baseline [Day 0 (D0)] to Days 28 (D28) and 84 (D84)
Population: Full Analysis Set (FAS) included any participant included in the study with at least a post-baseline value. Number analyzed is the number of participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Juvéderm® VOLITE Treated Zone | Change From Baseline in Skin Hydration as Measured by MoistureMeterD® 0.5 mm | Change from Baseline to Day 28 | 1.7 tissue dielectric constant | Standard Error 0.8 |
| Juvéderm® VOLITE Treated Zone | Change From Baseline in Skin Hydration as Measured by MoistureMeterD® 0.5 mm | Change from Baseline to Day 84 | 1.2 tissue dielectric constant | Standard Error 0.9 |
| Non-Treated Zone | Change From Baseline in Skin Hydration as Measured by MoistureMeterD® 0.5 mm | Change from Baseline to Day 28 | -0.0 tissue dielectric constant | Standard Error 0.7 |
| Non-Treated Zone | Change From Baseline in Skin Hydration as Measured by MoistureMeterD® 0.5 mm | Change from Baseline to Day 84 | 0.6 tissue dielectric constant | Standard Error 0.8 |
Comparison: Change from Baseline to Day 28p-value: 0.073695% CI: [-0.2, 3.6]Mixed ANOVA
Comparison: Change from Baseline to Day 84p-value: 0.525995% CI: [-1.5, 2.8]Mixed ANOVA
Primary
Change From Baseline in Skin Hydration as Measured by MoistureMeter D® 1.5 mm
Skin hydration was measured using MoistureMeter D® S15 (for epidermis and dermis), a non-invasive probe which measures the dielectric constant of the skin at a depth of 1.5 mm. 5 measurements were done on the same zone and the average value was calculated, expressed as TDC. The TDC is directly proportional to the amount of water in the tissue. A positive change from Baseline indicates better skin hydration. Values were obtained from a mixed ANOVA model. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.
Time frame: Baseline (D0) to D28 and D84
Population: FAS included any participant included in the study with at least a post-baseline value. Number analyzed is the number of participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Juvéderm® VOLITE Treated Zone | Change From Baseline in Skin Hydration as Measured by MoistureMeter D® 1.5 mm | Change from Baseline to Day 28 | 0.8 tissue dielectric constant | Standard Error 1.3 |
| Juvéderm® VOLITE Treated Zone | Change From Baseline in Skin Hydration as Measured by MoistureMeter D® 1.5 mm | Change from Baseline to Day 84 | 1.4 tissue dielectric constant | Standard Error 0.9 |
| Non-Treated Zone | Change From Baseline in Skin Hydration as Measured by MoistureMeter D® 1.5 mm | Change from Baseline to Day 28 | 1.0 tissue dielectric constant | Standard Error 1 |
| Non-Treated Zone | Change From Baseline in Skin Hydration as Measured by MoistureMeter D® 1.5 mm | Change from Baseline to Day 84 | 1.4 tissue dielectric constant | Standard Error 0.6 |
Comparison: Change from Baseline to Day 28p-value: 0.884895% CI: [-2.8, 2.4]Mixed ANOVA
Comparison: Change from Baseline to Day 84p-value: 0.950595% CI: [-1.8, 1.7]Mixed ANOVA
Primary
Number of Participants With at Least One Treatment-emergent Adverse Event (AE)
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A treatment-emergent AE is an AE that occurs or worsens after a participant receives study drug.
Time frame: First dose of study treatment to end of the study (Up to 9 months)
Population: Safety Population included any participant having used the tested device.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Juvéderm® VOLITE Treated Zone | Number of Participants With at Least One Treatment-emergent Adverse Event (AE) | 5 Participants |
Secondary
Change From Baseline in 300 μm Density as Measured by Vivosight OCT®
300 μm density is a skin vascularity parameter and was measured by Vivosight OCT® system which is used to obtain high resolution imaging of skin sub-structures and vascular networks. Values were obtained from a mixed ANOVA model. A positive change from Baseline indicates increased 300 μm density. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.
Time frame: Baseline (D0) to D28 and D84
Population: FAS included any participant included in the study with at least a post-baseline value. Number analyzed is the number of participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Juvéderm® VOLITE Treated Zone | Change From Baseline in 300 μm Density as Measured by Vivosight OCT® | Change from Baseline to Day 28 | 0.75 dimensionless | Standard Error 0.26 |
| Juvéderm® VOLITE Treated Zone | Change From Baseline in 300 μm Density as Measured by Vivosight OCT® | Change from Baseline to Day 84 | 0.13 dimensionless | Standard Error 0.29 |
| Non-Treated Zone | Change From Baseline in 300 μm Density as Measured by Vivosight OCT® | Change from Baseline to Day 28 | 0.17 dimensionless | Standard Error 0.31 |
| Non-Treated Zone | Change From Baseline in 300 μm Density as Measured by Vivosight OCT® | Change from Baseline to Day 84 | 0.33 dimensionless | Standard Error 0.34 |
Comparison: Change from Baseline to Day 28p-value: 0.057795% CI: [-0.02, 1.17]Mixed ANOVA
Comparison: Change from Baseline to Day 84p-value: 0.522495% CI: [-0.85, 0.45]Mixed ANOVA
Secondary
Change From Baseline in Epidermal Thickness as Measured by Vivosight OCT®
Epidermal thickness is a skin density parameter measured by Vivosight OCT® system used to obtain high resolution imaging of skin sub-structures and vascular networks. Values were obtained from a mixed ANOVA model. A positive change from Baseline indicates increased epidermal thickness. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.
Time frame: Baseline (D0) to D28 and D84
Population: FAS included any participant included in the study with at least a post-baseline value. Number analyzed is the number of participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Juvéderm® VOLITE Treated Zone | Change From Baseline in Epidermal Thickness as Measured by Vivosight OCT® | Change from Baseline to Day 28 | 1.79 µm | Standard Error 2.8 |
| Juvéderm® VOLITE Treated Zone | Change From Baseline in Epidermal Thickness as Measured by Vivosight OCT® | Change from Baseline to Day 84 | -1.93 µm | Standard Error 3.64 |
| Non-Treated Zone | Change From Baseline in Epidermal Thickness as Measured by Vivosight OCT® | Change from Baseline to Day 28 | 1.68 µm | Standard Error 2.22 |
| Non-Treated Zone | Change From Baseline in Epidermal Thickness as Measured by Vivosight OCT® | Change from Baseline to Day 84 | -0.51 µm | Standard Error 2.77 |
Comparison: Change from Baseline to Day 28p-value: 0.960895% CI: [-4.7, 4.91]Mixed ANOVA
Comparison: Change from Baseline to Day 84p-value: 0.619295% CI: [-7.48, 4.64]Mixed ANOVA
Secondary
Change From Baseline in Individual Typological Angle (ITA°) as Measured by Spectrophotometer®
Individual typological angle (ITA°), defines the skin pigmentation degree of a participant with taking into account the skin clarity (L\*) and the melanin parameter (b\*). 3 measurements were done on the same zone and the average values were calculated. Values were obtained from a mixed ANOVA model and expressed in degree (°). Higher values of ITA° indicates 'skin less pigmented'. A positive change from Baseline indicates less pigmented skin. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.
Time frame: Baseline (D0) to D28 and D84
Population: FAS included any participant included in the study with at least a post-baseline value. Number analyzed is the number of participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Juvéderm® VOLITE Treated Zone | Change From Baseline in Individual Typological Angle (ITA°) as Measured by Spectrophotometer® | Change from Baseline to Day 84 | 3.8 degree | Standard Error 1.2 |
| Juvéderm® VOLITE Treated Zone | Change From Baseline in Individual Typological Angle (ITA°) as Measured by Spectrophotometer® | Change from Baseline to Day 28 | 1.4 degree | Standard Error 0.6 |
| Non-Treated Zone | Change From Baseline in Individual Typological Angle (ITA°) as Measured by Spectrophotometer® | Change from Baseline to Day 28 | 2.0 degree | Standard Error 0.5 |
| Non-Treated Zone | Change From Baseline in Individual Typological Angle (ITA°) as Measured by Spectrophotometer® | Change from Baseline to Day 84 | 4.0 degree | Standard Error 1 |
Comparison: Change from Baseline to Day 28p-value: 0.197795% CI: [-1.6, 0.4]Mixed ANOVA
Comparison: Change from Baseline to Day 84p-value: 0.753595% CI: [-2.2, 1.7]Mixed ANOVA
Secondary
Change From Baseline in Optical Attenuation Coefficient (OAC) as Measured by Vivosight OCT®
OAC is a skin density parameter measured by Vivosight OCT® system used to obtain high resolution imaging of skin sub-structures and vascular networks. It analytically describes the reduction of OCT signal intensity with increasing depth-in-tissue. Values were obtained from a mixed ANOVA model. A positive change from Baseline indicates increased skin density. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.
Time frame: Baseline (D0) to D28 and D84
Population: FAS included any participant included in the study with at least a post-baseline value. Number analyzed is the number of participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Juvéderm® VOLITE Treated Zone | Change From Baseline in Optical Attenuation Coefficient (OAC) as Measured by Vivosight OCT® | Change from Baseline to Day 28 | 0.02 mm^-1 | Standard Error 0.09 |
| Juvéderm® VOLITE Treated Zone | Change From Baseline in Optical Attenuation Coefficient (OAC) as Measured by Vivosight OCT® | Change from Baseline to Day 84 | 0.07 mm^-1 | Standard Error 0.07 |
| Non-Treated Zone | Change From Baseline in Optical Attenuation Coefficient (OAC) as Measured by Vivosight OCT® | Change from Baseline to Day 28 | 0.04 mm^-1 | Standard Error 0.08 |
| Non-Treated Zone | Change From Baseline in Optical Attenuation Coefficient (OAC) as Measured by Vivosight OCT® | Change from Baseline to Day 84 | 0.18 mm^-1 | Standard Error 0.07 |
Comparison: Change from Baseline to Day 28p-value: 0.832295% CI: [-0.2, 0.16]Mixed ANOVA
Comparison: Change from Baseline to Day 84p-value: 0.133495% CI: [-0.25, 0.04]Mixed ANOVA
Secondary
Change From Baseline in Plexus Depth as Measured by Vivosight OCT®
Plexus depth is a skin vascularity parameter and was measured by Vivosight OCT® system which is used to obtain high resolution imaging of skin sub-structures and vascular networks. Values were obtained from a mixed ANOVA model. A negative change from Baseline indicates decreased plexus depth. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.
Time frame: Baseline (D0) to D28 and D84
Population: FAS included any participant included in the study with at least a post-baseline value. Number analyzed is the number of participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Juvéderm® VOLITE Treated Zone | Change From Baseline in Plexus Depth as Measured by Vivosight OCT® | Change from Baseline to Day 28 | -11.54 µm | Standard Error 4.89 |
| Juvéderm® VOLITE Treated Zone | Change From Baseline in Plexus Depth as Measured by Vivosight OCT® | Change from Baseline to Day 84 | -13.81 µm | Standard Error 5.07 |
| Non-Treated Zone | Change From Baseline in Plexus Depth as Measured by Vivosight OCT® | Change from Baseline to Day 28 | -6.45 µm | Standard Error 6.52 |
| Non-Treated Zone | Change From Baseline in Plexus Depth as Measured by Vivosight OCT® | Change from Baseline to Day 84 | -20.55 µm | Standard Error 6.84 |
Comparison: Change from Baseline to Day 28p-value: 0.522195% CI: [-21.56, 11.38]Mixed ANOVA
Comparison: Change from Baseline to Day 84p-value: 0.417495% CI: [-10.55, 24.03]Mixed ANOVA
Secondary
Change From Baseline in Skin Brightness Index as Measured by Glossymeter®
Skin brightness index was measured using Glossymeter®. 3 measurements were done on the same zone and the average value was calculated. Values were expressed in Glossymeter Units. Values were obtained from a mixed ANOVA model. Higher glossymeter values indicate higher skin brightness. A positive change from Baseline indicates increased skin brightness. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.
Time frame: Baseline (D0) to D28 and D84
Population: FAS included any participant included in the study with at least a post-baseline value. Number analyzed is the number of participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Juvéderm® VOLITE Treated Zone | Change From Baseline in Skin Brightness Index as Measured by Glossymeter® | Change from Baseline to Day 28 | 0.1 glossymeter unit | Standard Error 0.2 |
| Juvéderm® VOLITE Treated Zone | Change From Baseline in Skin Brightness Index as Measured by Glossymeter® | Change from Baseline to Day 84 | 0.4 glossymeter unit | Standard Error 0.2 |
| Non-Treated Zone | Change From Baseline in Skin Brightness Index as Measured by Glossymeter® | Change from Baseline to Day 28 | 0.3 glossymeter unit | Standard Error 0.1 |
| Non-Treated Zone | Change From Baseline in Skin Brightness Index as Measured by Glossymeter® | Change from Baseline to Day 84 | 0.2 glossymeter unit | Standard Error 0.2 |
Comparison: Change from Baseline to Day 28p-value: 0.266695% CI: [-0.6, 0.2]Mixed ANOVA
Comparison: Change from Baseline to Day 84p-value: 0.436695% CI: [-0.3, 0.7]Mixed ANOVA
Secondary
Change From Baseline in Skin Colour as Measured by Spectrophotometer®
Skin colour was measured by Spectrophotometer®. It converts colours perceived by man to a digital code composed of three parameters: L\*: for clarity (from dark to light) a\*: for the green-to-red spectrum b\*: for the blue-to-yellow spectrum; a\* and b\* are chrominance parameters, L\* is a luminance parameter. Higher values of a\*, b\*and L\* indicates 'skin more red', 'skin more yellow' and 'skin clearer'. Values were obtained from a mixed ANOVA model and expressed in arbitrary units. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.
Time frame: Baseline (D0) to D28 and D84
Population: FAS included any participant included in the study with at least a post-baseline value. Number analyzed is the number of participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Juvéderm® VOLITE Treated Zone | Change From Baseline in Skin Colour as Measured by Spectrophotometer® | a*: Change from Baseline to Day 28 | -0.3 arbitrary units | Standard Error 0.2 |
| Juvéderm® VOLITE Treated Zone | Change From Baseline in Skin Colour as Measured by Spectrophotometer® | a*: Change from Baseline to Day 84 | 0.8 arbitrary units | Standard Error 0.3 |
| Juvéderm® VOLITE Treated Zone | Change From Baseline in Skin Colour as Measured by Spectrophotometer® | b*: Change from Baseline to Day 28 | -0.3 arbitrary units | Standard Error 0.3 |
| Juvéderm® VOLITE Treated Zone | Change From Baseline in Skin Colour as Measured by Spectrophotometer® | b*: Change from Baseline to Day 84 | -1.4 arbitrary units | Standard Error 0.4 |
| Juvéderm® VOLITE Treated Zone | Change From Baseline in Skin Colour as Measured by Spectrophotometer® | L*: Change from Baseline to Day 28 | 0.4 arbitrary units | Standard Error 0.3 |
| Juvéderm® VOLITE Treated Zone | Change From Baseline in Skin Colour as Measured by Spectrophotometer® | L*: Change from Baseline to Day 84 | 0.7 arbitrary units | Standard Error 0.3 |
| Non-Treated Zone | Change From Baseline in Skin Colour as Measured by Spectrophotometer® | L*: Change from Baseline to Day 28 | 0.8 arbitrary units | Standard Error 0.3 |
| Non-Treated Zone | Change From Baseline in Skin Colour as Measured by Spectrophotometer® | a*: Change from Baseline to Day 28 | -0.1 arbitrary units | Standard Error 0.2 |
| Non-Treated Zone | Change From Baseline in Skin Colour as Measured by Spectrophotometer® | b*: Change from Baseline to Day 84 | -1.1 arbitrary units | Standard Error 0.4 |
| Non-Treated Zone | Change From Baseline in Skin Colour as Measured by Spectrophotometer® | a*: Change from Baseline to Day 84 | -0.7 arbitrary units | Standard Error 0.2 |
| Non-Treated Zone | Change From Baseline in Skin Colour as Measured by Spectrophotometer® | L*: Change from Baseline to Day 84 | 1.1 arbitrary units | Standard Error 0.3 |
| Non-Treated Zone | Change From Baseline in Skin Colour as Measured by Spectrophotometer® | b*: Change from Baseline to Day 28 | -0.2 arbitrary units | Standard Error 0.2 |
Comparison: a\*: Change from Baseline to Day 28p-value: 0.419795% CI: [-0.6, 0.3]Mixed ANOVA
Comparison: a\*: Change from Baseline to Day 84p-value: 0.91495% CI: [-0.6, 0.5]Mixed ANOVA
Comparison: b\*: Change from Baseline to Day 28p-value: 0.760495% CI: [-0.6, 0.4]Mixed ANOVA
Comparison: b\*: Change from Baseline to Day 84p-value: 0.593695% CI: [-1, 0.6]Mixed ANOVA
Comparison: L\*: Change from Baseline to Day 28p-value: 0.080895% CI: [-0.9, 0.1]Mixed ANOVA
Comparison: L\*: Change from Baseline to Day 84p-value: 0.163395% CI: [-1, 0.2]Mixed ANOVA
Secondary
Change From Baseline in Skin Density as Measured by Skin Scanner®
Skin density was measured as the percentage of echogenic surface using SkinScanner®, a high frequency echograph. Values were obtained from a mixed ANOVA model. A positive change from Baseline indicates increased skin density. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.
Time frame: Baseline (D0) to D28 and D84
Population: FAS included any participant included in the study with at least a post-baseline value. Number analyzed is the number of participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Juvéderm® VOLITE Treated Zone | Change From Baseline in Skin Density as Measured by Skin Scanner® | Change from Baseline to Day 28 | 4.69 percentage of echogenic surface | Standard Error 2.82 |
| Juvéderm® VOLITE Treated Zone | Change From Baseline in Skin Density as Measured by Skin Scanner® | Change from Baseline to Day 84 | 8.56 percentage of echogenic surface | Standard Error 2.65 |
| Non-Treated Zone | Change From Baseline in Skin Density as Measured by Skin Scanner® | Change from Baseline to Day 28 | -1.83 percentage of echogenic surface | Standard Error 2.31 |
| Non-Treated Zone | Change From Baseline in Skin Density as Measured by Skin Scanner® | Change from Baseline to Day 84 | 3.00 percentage of echogenic surface | Standard Error 2.27 |
Comparison: Change from Baseline to Day 28p-value: 0.079895% CI: [-0.89, 13.93]Mixed ANOVA
Comparison: Change from Baseline to Day 84p-value: 0.114295% CI: [-1.55, 12.67]Mixed ANOVA
Secondary
Change From Baseline in Skin Elasticity as Measured by Elastimeter®
Instant skin elasticity was measured with Elastimeter® and defines the skin elasticity determined as a resistance against deformation caused by the Elastimeter® probe on the skin surface. 3 measurements were done on the same zone and the average value was calculated. The values were expressed in Newton/meter. Higher values of ISE indicate higher skin elasticity. A positive change from Baseline indicates increased skin elasticity. Values were obtained from a mixed ANOVA model. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.
Time frame: Baseline (D0) to D28 and D84
Population: FAS included any participant included in the study with at least a post-baseline value. Number analyzed is the number of participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Juvéderm® VOLITE Treated Zone | Change From Baseline in Skin Elasticity as Measured by Elastimeter® | Change from Baseline to Day 28 | 4.45 Newton/meter | Standard Error 2.12 |
| Juvéderm® VOLITE Treated Zone | Change From Baseline in Skin Elasticity as Measured by Elastimeter® | Change from Baseline to Day 84 | 3.90 Newton/meter | Standard Error 3.2 |
| Non-Treated Zone | Change From Baseline in Skin Elasticity as Measured by Elastimeter® | Change from Baseline to Day 28 | 5.00 Newton/meter | Standard Error 2.3 |
| Non-Treated Zone | Change From Baseline in Skin Elasticity as Measured by Elastimeter® | Change from Baseline to Day 84 | 4.32 Newton/meter | Standard Error 3.49 |
Comparison: Change from Baseline to Day 28p-value: 0.840995% CI: [-6.19, 5.1]Mixed ANOVA
Comparison: Change from Baseline to Day 84p-value: 0.918395% CI: [-9.18, 8.35]Mixed ANOVA
Secondary
Change From Baseline in Skin Melanin Index as Measured by Mexameter®
Melanin index measured with Mexameter® defines the skin pigmentation related to melanin content in the skin. Measurements are performed by the application of a probe to the skin surface. The probe has a 5 mm aperture that emits radiations. These radiations are reflected by the skin and captured back by the same probe. The results are expressed as an index value for each parameter in arbitrary units from 0 to 999. 3 measurements were done on the same zone and the average value was calculated. Values were obtained from a mixed ANOVA model. A negative change from Baseline indicates less pigmented skin. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.
Time frame: Baseline (D0) to D28 and D84
Population: FAS included any participant included in the study with at least a post-baseline value. Number analyzed is the number of participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Juvéderm® VOLITE Treated Zone | Change From Baseline in Skin Melanin Index as Measured by Mexameter® | Change from Baseline to Day 28 | -3.78 arbitrary units | Standard Error 4.66 |
| Juvéderm® VOLITE Treated Zone | Change From Baseline in Skin Melanin Index as Measured by Mexameter® | Change from Baseline to Day 84 | -2.53 arbitrary units | Standard Error 7.44 |
| Non-Treated Zone | Change From Baseline in Skin Melanin Index as Measured by Mexameter® | Change from Baseline to Day 28 | -8.13 arbitrary units | Standard Error 3.34 |
| Non-Treated Zone | Change From Baseline in Skin Melanin Index as Measured by Mexameter® | Change from Baseline to Day 84 | -19.79 arbitrary units | Standard Error 5.47 |
Comparison: Change from Baseline to Day 28p-value: 0.290595% CI: [-4.16, 12.85]Mixed ANOVA
Comparison: Change from Baseline to Day 84p-value: 0.024195% CI: [2.84, 31.69]Mixed ANOVA
Secondary
Change From Baseline in Skin Roughness as Measured by Vivosight OCT®
Skin roughness was measured by Vivosight optical coherence tomography (OCT®) system which is used to obtain high resolution imaging of skin sub-structures and vascular networks. The skin roughness parameters from the images included Ra and Rz. Ra is a measure of the average length that is between peaks and valleys. Rz helps measure the vertical distance between the highest peak and the lowest valley. Values were obtained from a mixed ANOVA model. A negative change from Baseline indicates decreased skin roughness. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.
Time frame: Baseline (D0) to D28 and D84
Population: FAS included any participant included in the study with at least a post-baseline value. Number analyzed is the number of participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Juvéderm® VOLITE Treated Zone | Change From Baseline in Skin Roughness as Measured by Vivosight OCT® | Ra: Change from Baseline to Day 28 | -0.94 µm | Standard Error 0.64 |
| Juvéderm® VOLITE Treated Zone | Change From Baseline in Skin Roughness as Measured by Vivosight OCT® | Ra: Change from Baseline to Day 84 | -0.27 µm | Standard Error 0.53 |
| Juvéderm® VOLITE Treated Zone | Change From Baseline in Skin Roughness as Measured by Vivosight OCT® | Rz: Change from Baseline to Day 28 | -3.95 µm | Standard Error 3.59 |
| Juvéderm® VOLITE Treated Zone | Change From Baseline in Skin Roughness as Measured by Vivosight OCT® | Rz: Change from Baseline to Day 84 | -3.64 µm | Standard Error 3.26 |
| Non-Treated Zone | Change From Baseline in Skin Roughness as Measured by Vivosight OCT® | Rz: Change from Baseline to Day 84 | -11.86 µm | Standard Error 3.35 |
| Non-Treated Zone | Change From Baseline in Skin Roughness as Measured by Vivosight OCT® | Ra: Change from Baseline to Day 28 | -1.90 µm | Standard Error 0.63 |
| Non-Treated Zone | Change From Baseline in Skin Roughness as Measured by Vivosight OCT® | Rz: Change from Baseline to Day 28 | -9.85 µm | Standard Error 3.53 |
| Non-Treated Zone | Change From Baseline in Skin Roughness as Measured by Vivosight OCT® | Ra: Change from Baseline to Day 84 | -1.37 µm | Standard Error 0.54 |
Comparison: Ra: Change from Baseline to Day 28p-value: 0.259295% CI: [-0.78, 2.71]Mixed ANOVA
Comparison: Ra: Change from Baseline to Day 84p-value: 0.134195% CI: [-0.38, 2.57]Mixed ANOVA
Comparison: Rz: Change from Baseline to Day 28p-value: 0.213895% CI: [-3.79, 15.61]Mixed ANOVA
Comparison: Rz: Change from Baseline to Day 84p-value: 0.0795% CI: [-0.77, 17.2]Mixed ANOVA
Secondary
Change From Baseline in Skin Thickness as Measured by Skin Scanner®
Skin thickness was measured as the average thickness of the epidermis and dermis (in mm) using SkinScanner®, a high frequency echograph. Values were obtained from a mixed ANOVA model. A positive change from Baseline indicates increased skin thickness. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.
Time frame: Baseline (D0) to D28 and D84
Population: FAS included any participant included in the study with at least a post-baseline value. Number analyzed is the number of participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Juvéderm® VOLITE Treated Zone | Change From Baseline in Skin Thickness as Measured by Skin Scanner® | Change from Baseline to Day 28 | 56 mm | Standard Error 72 |
| Juvéderm® VOLITE Treated Zone | Change From Baseline in Skin Thickness as Measured by Skin Scanner® | Change from Baseline to Day 84 | -85 mm | Standard Error 74 |
| Non-Treated Zone | Change From Baseline in Skin Thickness as Measured by Skin Scanner® | Change from Baseline to Day 28 | -14 mm | Standard Error 35 |
| Non-Treated Zone | Change From Baseline in Skin Thickness as Measured by Skin Scanner® | Change from Baseline to Day 84 | -3 mm | Standard Error 36 |
Comparison: Change from Baseline to Day 28p-value: 0.412895% CI: [-142, 282]Mixed ANOVA
Comparison: Change from Baseline to Day 84p-value: 0.385195% CI: [-355, 191]Mixed ANOVA
Secondary
Change From Baseline in Vessel Density as Measured by Vivosight OCT®
Vessel density is a skin vascularity parameter and was measured by Vivosight OCT® system which is used to obtain high resolution imaging of skin sub-structures and vascular networks. A positive change from Baseline indicates increased vessel density. Values were obtained from a mixed ANOVA model. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.
Time frame: Baseline (D0) to D28 and D84
Population: FAS included any participant included in the study with at least a post-baseline value. Number analyzed is the number of participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Juvéderm® VOLITE Treated Zone | Change From Baseline in Vessel Density as Measured by Vivosight OCT® | Change from Baseline to Day 28 | 0.47 dimensionless | Standard Error 0.5 |
| Juvéderm® VOLITE Treated Zone | Change From Baseline in Vessel Density as Measured by Vivosight OCT® | Change from Baseline to Day 84 | 0.19 dimensionless | Standard Error 0.31 |
| Non-Treated Zone | Change From Baseline in Vessel Density as Measured by Vivosight OCT® | Change from Baseline to Day 28 | -0.23 dimensionless | Standard Error 0.47 |
| Non-Treated Zone | Change From Baseline in Vessel Density as Measured by Vivosight OCT® | Change from Baseline to Day 84 | -0.36 dimensionless | Standard Error 0.3 |
Comparison: Change from Baseline to Day 28p-value: 0.167295% CI: [-0.33, 1.73]Mixed ANOVA
Comparison: Change from Baseline to Day 84p-value: 0.088195% CI: [-0.1, 1.21]Mixed ANOVA
Secondary
Change From Baseline in Vessel Diameter as Measured by Vivosight OCT®
Vessel diameter is a skin vascularity parameter and was measured by Vivosight OCT® system which is used to obtain high resolution imaging of skin sub-structures and vascular networks. Values were obtained from a mixed ANOVA model. A positive change from Baseline indicates increased vessel diameter. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.
Time frame: Baseline (D0) to D28 and D84
Population: FAS included any participant included in the study with at least a post-baseline value. Number analyzed is the number of participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Juvéderm® VOLITE Treated Zone | Change From Baseline in Vessel Diameter as Measured by Vivosight OCT® | Change from Baseline to Day 28 | 2.59 µm | Standard Error 2.42 |
| Juvéderm® VOLITE Treated Zone | Change From Baseline in Vessel Diameter as Measured by Vivosight OCT® | Change from Baseline to Day 84 | 3.66 µm | Standard Error 2.35 |
| Non-Treated Zone | Change From Baseline in Vessel Diameter as Measured by Vivosight OCT® | Change from Baseline to Day 28 | -0.18 µm | Standard Error 2.62 |
| Non-Treated Zone | Change From Baseline in Vessel Diameter as Measured by Vivosight OCT® | Change from Baseline to Day 84 | -6.33 µm | Standard Error 2.63 |
Comparison: Change from Baseline to Day 28p-value: 0.305295% CI: [-2.9, 8.44]Mixed ANOVA
Comparison: Change from Baseline to Day 84p-value: 0.001695% CI: [4.48, 15.5]Mixed ANOVA
Secondary
Number of Participants With Injection Site Reactions (ISR)
ISRs are reactions that occur after injection of the study drug. The following ISRs: Redness/Erythema, Pain/Tenderness, Induration, Swelling/Oedema, Lumps/Bumps, Bruising/Hematoma, Itching, Discoloration/Pigmentation were reported as None, Mild, Moderate or Severe. Only those categories reported for at least 1 participant are reported.
Time frame: Day 0
Population: Safety Population included any participant having used the tested device.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Juvéderm® VOLITE Treated Zone | Number of Participants With Injection Site Reactions (ISR) | Redness/Erythema: Mild | 11 Participants |
| Juvéderm® VOLITE Treated Zone | Number of Participants With Injection Site Reactions (ISR) | Pain/Tenderness: None | 4 Participants |
| Juvéderm® VOLITE Treated Zone | Number of Participants With Injection Site Reactions (ISR) | Pain/Tenderness: Mild | 7 Participants |
| Juvéderm® VOLITE Treated Zone | Number of Participants With Injection Site Reactions (ISR) | Induration: None | 11 Participants |
| Juvéderm® VOLITE Treated Zone | Number of Participants With Injection Site Reactions (ISR) | Swelling/Oedema: None | 4 Participants |
| Juvéderm® VOLITE Treated Zone | Number of Participants With Injection Site Reactions (ISR) | Swelling/Oedema: Mild | 7 Participants |
| Juvéderm® VOLITE Treated Zone | Number of Participants With Injection Site Reactions (ISR) | Lumps/Bumps: None | 3 Participants |
| Juvéderm® VOLITE Treated Zone | Number of Participants With Injection Site Reactions (ISR) | Lumps/Bumps: Mild | 8 Participants |
| Juvéderm® VOLITE Treated Zone | Number of Participants With Injection Site Reactions (ISR) | Bruising/Hematoma: None | 4 Participants |
| Juvéderm® VOLITE Treated Zone | Number of Participants With Injection Site Reactions (ISR) | Bruising/Hematoma: Mild | 6 Participants |
| Juvéderm® VOLITE Treated Zone | Number of Participants With Injection Site Reactions (ISR) | Bruising/Hematoma: Moderate | 1 Participants |
| Juvéderm® VOLITE Treated Zone | Number of Participants With Injection Site Reactions (ISR) | Itching: None | 11 Participants |
| Juvéderm® VOLITE Treated Zone | Number of Participants With Injection Site Reactions (ISR) | Discoloration/Pigmentation: None | 11 Participants |