Trial Outcomes & Findings for A Study to Evaluate The Impact on Skin Quality Attributes by Juvederm® Volite Injection on Healthy Volunteers (NCT NCT04206293)
NCT ID: NCT04206293
Last Updated: 2021-08-26
Results Overview
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.
COMPLETED
NA
11 participants
Baseline [Day 0 (D0)] to Days 28 (D28) and 84 (D84)
2021-08-26
Participant Flow
Participant milestones
| Measure |
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.
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Overall Study
STARTED
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11
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Overall Study
COMPLETED
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10
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
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.
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Overall Study
Consent withdrawal
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1
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Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Juvéderm® VOLITE Treated Zone
n=11 Participants
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.
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Age, Continuous
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40.82 years
STANDARD_DEVIATION 6.10 • n=11 Participants
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Sex: Female, Male
Female
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9 Participants
n=11 Participants
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Sex: Female, Male
Male
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2 Participants
n=11 Participants
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Skin Hydration (MoistureMeterD® XS Probe)
Juvéderm® VOLITE Treated Zone
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32.6 tissue dielectric constant
STANDARD_DEVIATION 4.3 • n=11 Participants
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Skin Hydration (MoistureMeterD® XS Probe)
Non-Treated Zone
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35.9 tissue dielectric constant
STANDARD_DEVIATION 5.3 • n=11 Participants
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Skin Hydration (MoistureMeterD® S Probe)
Juvéderm® VOLITE Treated Zone
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35.9 tissue dielectric constant
STANDARD_DEVIATION 5.3 • n=11 Participants
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Skin Hydration (MoistureMeterD® S Probe)
Non-Treated Zone
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30.6 tissue dielectric constant
STANDARD_DEVIATION 2.6 • n=11 Participants
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Skin Hydration (Corneometer®)
Juvéderm® VOLITE Treated Zone
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29.5 arbitrary units of hydration
STANDARD_DEVIATION 5.5 • n=11 Participants
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Skin Hydration (Corneometer®)
Non-Treated Zone
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29.3 arbitrary units of hydration
STANDARD_DEVIATION 5.5 • n=11 Participants
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Skin Elasticity Parameters (Cutometer ®)
Uf: Juvéderm® VOLITE Treated Zone
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0.989 millimeters (mm)
STANDARD_DEVIATION 0.109 • n=11 Participants
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Skin Elasticity Parameters (Cutometer ®)
Uf: Non-Treated Zone
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1.041 millimeters (mm)
STANDARD_DEVIATION 0.127 • n=11 Participants
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Skin Elasticity Parameters (Cutometer ®)
Ue: Juvéderm® VOLITE Treated Zone
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0.816 millimeters (mm)
STANDARD_DEVIATION 0.100 • n=11 Participants
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Skin Elasticity Parameters (Cutometer ®)
Ue: Non-Treated Zone
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0.864 millimeters (mm)
STANDARD_DEVIATION 0.115 • n=11 Participants
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Skin Elasticity Parameters (Cutometer ®)
Ur: Juvéderm® VOLITE Treated Zone
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0.660 millimeters (mm)
STANDARD_DEVIATION 0.131 • n=11 Participants
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Skin Elasticity Parameters (Cutometer ®)
Ur: Non-Treated Zone
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0.777 millimeters (mm)
STANDARD_DEVIATION 0.138 • n=11 Participants
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Skin Elasticity Parameters (Cutometer ®)
Ua: Juvéderm® VOLITE Treated Zone
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0.844 millimeters (mm)
STANDARD_DEVIATION 0.125 • n=11 Participants
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Skin Elasticity Parameters (Cutometer ®)
Ua: Non-Treated Zone
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0.916 millimeters (mm)
STANDARD_DEVIATION 0.131 • n=11 Participants
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Relative Parameters of Skin Elasticity (Cutometer ®)
Elastic Recovery (Q1): Juvéderm® VOLITE Treated Zone
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0.781 dimensionless
STANDARD_DEVIATION 0.052 • n=11 Participants
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Relative Parameters of Skin Elasticity (Cutometer ®)
Elastic Recovery (Q1): Non-Treated Zone
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0.825 dimensionless
STANDARD_DEVIATION 0.046 • n=11 Participants
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Relative Parameters of Skin Elasticity (Cutometer ®)
Viscous Recovery (Q2): Juvéderm® VOLITE Treated Zone
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0.630 dimensionless
STANDARD_DEVIATION 0.083 • n=11 Participants
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Relative Parameters of Skin Elasticity (Cutometer ®)
Viscous Recovery (Q2): Non-Treated Zone
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0.716 dimensionless
STANDARD_DEVIATION 0.073 • n=11 Participants
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Relative Parameters of Skin Elasticity (Cutometer ®)
Viscoelastic Recovery (Q3): Juvéderm® VOLITE Treated Zone
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0.151 dimensionless
STANDARD_DEVIATION 0.034 • n=11 Participants
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Relative Parameters of Skin Elasticity (Cutometer ®)
Viscoelastic Recovery (Q3): Non-Treated Zone
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0.109 dimensionless
STANDARD_DEVIATION 0.028 • n=11 Participants
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Skin Elasticity
Juvéderm® VOLITE Treated Zone
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40.91 Newton/meter
STANDARD_DEVIATION 10.27 • n=11 Participants
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Skin Elasticity
Non-Treated Zone
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38.55 Newton/meter
STANDARD_DEVIATION 11.49 • n=11 Participants
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Skin Thickness (Skin Scanner®)
Juvéderm® VOLITE Treated Zone
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1246 mm
STANDARD_DEVIATION 160 • n=11 Participants
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Skin Thickness (Skin Scanner®)
Non-Treated Zone
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1064 mm
STANDARD_DEVIATION 121 • n=11 Participants
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Skin Density (Skin Scanner®)
Juvéderm® VOLITE Treated Zone
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33.63 percentage of echogenic surface
STANDARD_DEVIATION 5.29 • n=11 Participants
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Skin Density (Skin Scanner®)
Non-Treated Zone
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44.05 percentage of echogenic surface
STANDARD_DEVIATION 7.05 • n=11 Participants
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Skin Roughness (Vivosight OCT®)
Ra: Juvéderm® VOLITE Treated Zone
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13.81 micrometer (µm)
STANDARD_DEVIATION 2.99 • n=11 Participants
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Skin Roughness (Vivosight OCT®)
Ra: Non-Treated Zone
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18.17 micrometer (µm)
STANDARD_DEVIATION 2.16 • n=11 Participants
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Skin Roughness (Vivosight OCT®)
Rz: Juvéderm® VOLITE Treated Zone
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89.50 micrometer (µm)
STANDARD_DEVIATION 16.63 • n=11 Participants
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Skin Roughness (Vivosight OCT®)
Rz: Non-Treated Zone
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111.73 micrometer (µm)
STANDARD_DEVIATION 10.63 • n=11 Participants
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Epidermal Thickness (Vivosight OCT®)
Juvéderm® VOLITE Treated Zone
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92.64 µm
STANDARD_DEVIATION 14.93 • n=11 Participants
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Epidermal Thickness (Vivosight OCT®)
Non-Treated Zone
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94.58 µm
STANDARD_DEVIATION 8.70 • n=11 Participants
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Optical Attenuation Coefficient (OAC) (Vivosight OCT®)
Juvéderm® VOLITE Treated Zone
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2.61 per mm (mm^-1)
STANDARD_DEVIATION 0.27 • n=11 Participants
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Optical Attenuation Coefficient (OAC) (Vivosight OCT®)
Non-Treated Zone
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2.71 per mm (mm^-1)
STANDARD_DEVIATION 0.21 • n=11 Participants
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Plexus Depth (Vivosight OCT®)
Juvéderm® VOLITE Treated Zone
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332.59 µm
STANDARD_DEVIATION 13.90 • n=11 Participants
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Plexus Depth (Vivosight OCT®)
Non-Treated Zone
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319.67 µm
STANDARD_DEVIATION 17.84 • n=11 Participants
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Vessel Diameter (Vivosight OCT®)
Juvéderm® VOLITE Treated Zone
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44.13 µm
STANDARD_DEVIATION 8.12 • n=11 Participants
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Vessel Diameter (Vivosight OCT®)
Non-Treated Zone
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46.64 µm
STANDARD_DEVIATION 8.60 • n=11 Participants
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Vessel Density
Juvéderm® VOLITE Treated Zone
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1.98 dimensionless
STANDARD_DEVIATION 0.98 • n=11 Participants
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Vessel Density
Non-Treated Zone
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2.24 dimensionless
STANDARD_DEVIATION 1.05 • n=11 Participants
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300 μm Density
Juvéderm® VOLITE Treated Zone
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2.61 dimensionless
STANDARD_DEVIATION 0.62 • n=11 Participants
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300 μm Density
Non-Treated Zone
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2.84 dimensionless
STANDARD_DEVIATION 0.70 • n=11 Participants
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Skin Brightness Index
Juvéderm® VOLITE Treated Zone
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6.3 glossymeter units
STANDARD_DEVIATION 1.1 • n=11 Participants
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Skin Brightness Index
Non-Treated Zone
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5.7 glossymeter units
STANDARD_DEVIATION 0.8 • n=11 Participants
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Skin Colour (Spectrophotometer®)
a*: Juvéderm® VOLITE Treated Zone
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6.3 arbitrary units
STANDARD_DEVIATION 2.0 • n=11 Participants
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Skin Colour (Spectrophotometer®)
a*: Non-Treated Zone
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7.0 arbitrary units
STANDARD_DEVIATION 1.5 • n=11 Participants
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Skin Colour (Spectrophotometer®)
b*: Juvéderm® VOLITE Treated Zone
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17.2 arbitrary units
STANDARD_DEVIATION 2.7 • n=11 Participants
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Skin Colour (Spectrophotometer®)
b*: Non-Treated Zone
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17.8 arbitrary units
STANDARD_DEVIATION 2.3 • n=11 Participants
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Skin Colour (Spectrophotometer®)
L*: Juvéderm® VOLITE Treated Zone
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64.7 arbitrary units
STANDARD_DEVIATION 2.8 • n=11 Participants
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Skin Colour (Spectrophotometer®)
L*: Non-Treated Zone
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64.1 arbitrary units
STANDARD_DEVIATION 2.5 • n=11 Participants
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Individual Typological Angle (ITA°) (Spectrophotometer®)
Juvéderm® VOLITE Treated Zone
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40.5 degree
STANDARD_DEVIATION 9.3 • n=11 Participants
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Individual Typological Angle (ITA°) (Spectrophotometer®)
Non-Treated Zone
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38.4 degree
STANDARD_DEVIATION 8.1 • n=11 Participants
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Skin Melanin Index (Mexameter®)
Juvéderm® VOLITE Treated Zone
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150.03 arbitrary units
STANDARD_DEVIATION 38.45 • n=11 Participants
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Skin Melanin Index (Mexameter®)
Non-Treated Zone
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181.40 arbitrary units
STANDARD_DEVIATION 32.49 • n=11 Participants
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PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Juvéderm® VOLITE Treated Zone
n=11 Participants
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.
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Non-Treated Zone
n=11 Participants
The not-treated zone of the same arm in same the participant served as a control.
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Change From Baseline in Skin Hydration as Measured by MoistureMeterD® 0.5 mm
Change from Baseline to Day 28
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1.7 tissue dielectric constant
Standard Error 0.8
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-0.0 tissue dielectric constant
Standard Error 0.7
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Change From Baseline in Skin Hydration as Measured by MoistureMeterD® 0.5 mm
Change from Baseline to Day 84
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1.2 tissue dielectric constant
Standard Error 0.9
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0.6 tissue dielectric constant
Standard Error 0.8
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PRIMARY outcome
Timeframe: Baseline (D0) to D28 and D84Population: 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.
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.
Outcome measures
| Measure |
Juvéderm® VOLITE Treated Zone
n=11 Participants
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.
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Non-Treated Zone
n=11 Participants
The not-treated zone of the same arm in same the participant served as a control.
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Change From Baseline in Skin Hydration as Measured by MoistureMeter D® 1.5 mm
Change from Baseline to Day 28
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0.8 tissue dielectric constant
Standard Error 1.3
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1.0 tissue dielectric constant
Standard Error 1.0
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Change From Baseline in Skin Hydration as Measured by MoistureMeter D® 1.5 mm
Change from Baseline to Day 84
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1.4 tissue dielectric constant
Standard Error 0.9
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1.4 tissue dielectric constant
Standard Error 0.6
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PRIMARY outcome
Timeframe: Baseline (D0) to D28 and D84Population: 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.
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.
Outcome measures
| Measure |
Juvéderm® VOLITE Treated Zone
n=11 Participants
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.
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Non-Treated Zone
n=11 Participants
The not-treated zone of the same arm in same the participant served as a control.
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Change From Baseline in Skin Hydration as Measured by Corneometer®
Change from Baseline to Day 28
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1.3 arbitrary units of hydration
Standard Error 1.1
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-1.4 arbitrary units of hydration
Standard Error 1.0
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Change From Baseline in Skin Hydration as Measured by Corneometer®
Change from Baseline to Day 84
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2.5 arbitrary units of hydration
Standard Error 1.2
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0.1 arbitrary units of hydration
Standard Error 1.2
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PRIMARY outcome
Timeframe: Baseline (D0) to D28 and D84Population: 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.
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.
Outcome measures
| Measure |
Juvéderm® VOLITE Treated Zone
n=11 Participants
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.
|
Non-Treated Zone
n=11 Participants
The not-treated zone of the same arm in same the participant served as a control.
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|---|---|---|
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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
|
0.003 mm
Standard Error 0.008
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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
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-0.003 mm
Standard Error 0.007
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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 0.010
|
-0.005 mm
Standard Error 0.013
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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
|
0.006 mm
Standard Error 0.009
|
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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
|
-0.018 mm
Standard Error 0.020
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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
|
-0.022 mm
Standard Error 0.015
|
|
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
|
-0.009 mm
Standard Error 0.015
|
|
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
|
-0.016 mm
Standard Error 0.010
|
PRIMARY outcome
Timeframe: Baseline (D0) to D28 and D84Population: 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.
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.
Outcome measures
| Measure |
Juvéderm® VOLITE Treated Zone
n=11 Participants
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.
|
Non-Treated Zone
n=11 Participants
The not-treated zone of the same arm in same the participant served as a control.
|
|---|---|---|
|
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
|
-0.017 dimensionless
Standard Error 0.013
|
|
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
|
-0.018 dimensionless
Standard Error 0.011
|
|
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
|
-0.023 dimensionless
Standard Error 0.018
|
|
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
|
-0.019 dimensionless
Standard Error 0.015
|
|
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
|
0.006 dimensionless
Standard Error 0.007
|
|
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
|
0.001 dimensionless
Standard Error 0.006
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Juvéderm® VOLITE Treated Zone
n=11 Participants
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.
|
Non-Treated Zone
The not-treated zone of the same arm in same the participant served as a control.
|
|---|---|---|
|
Number of Participants With at Least One Treatment-emergent Adverse Event (AE)
|
5 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline (D0) to D28 and D84Population: 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.
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.
Outcome measures
| Measure |
Juvéderm® VOLITE Treated Zone
n=11 Participants
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.
|
Non-Treated Zone
n=11 Participants
The not-treated zone of the same arm in same the participant served as a control.
|
|---|---|---|
|
Change From Baseline in Skin Elasticity as Measured by Elastimeter®
Change from Baseline to Day 28
|
4.45 Newton/meter
Standard Error 2.12
|
5.00 Newton/meter
Standard Error 2.30
|
|
Change From Baseline in Skin Elasticity as Measured by Elastimeter®
Change from Baseline to Day 84
|
3.90 Newton/meter
Standard Error 3.20
|
4.32 Newton/meter
Standard Error 3.49
|
SECONDARY outcome
Timeframe: Baseline (D0) to D28 and D84Population: 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.
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.
Outcome measures
| Measure |
Juvéderm® VOLITE Treated Zone
n=11 Participants
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.
|
Non-Treated Zone
n=11 Participants
The not-treated zone of the same arm in same the participant served as a control.
|
|---|---|---|
|
Change From Baseline in Skin Thickness as Measured by Skin Scanner®
Change from Baseline to Day 28
|
56 mm
Standard Error 72
|
-14 mm
Standard Error 35
|
|
Change From Baseline in Skin Thickness as Measured by Skin Scanner®
Change from Baseline to Day 84
|
-85 mm
Standard Error 74
|
-3 mm
Standard Error 36
|
SECONDARY outcome
Timeframe: Baseline (D0) to D28 and D84Population: 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.
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.
Outcome measures
| Measure |
Juvéderm® VOLITE Treated Zone
n=11 Participants
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.
|
Non-Treated Zone
n=11 Participants
The not-treated zone of the same arm in same the participant served as a control.
|
|---|---|---|
|
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
|
-1.83 percentage of echogenic surface
Standard Error 2.31
|
|
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
|
3.00 percentage of echogenic surface
Standard Error 2.27
|
SECONDARY outcome
Timeframe: Baseline (D0) to D28 and D84Population: 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.
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.
Outcome measures
| Measure |
Juvéderm® VOLITE Treated Zone
n=11 Participants
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.
|
Non-Treated Zone
n=11 Participants
The not-treated zone of the same arm in same the participant served as a control.
|
|---|---|---|
|
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
|
-1.90 µm
Standard Error 0.63
|
|
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
|
-1.37 µm
Standard Error 0.54
|
|
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
|
-9.85 µm
Standard Error 3.53
|
|
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
|
-11.86 µm
Standard Error 3.35
|
SECONDARY outcome
Timeframe: Baseline (D0) to D28 and D84Population: 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.
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.
Outcome measures
| Measure |
Juvéderm® VOLITE Treated Zone
n=11 Participants
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.
|
Non-Treated Zone
n=11 Participants
The not-treated zone of the same arm in same the participant served as a control.
|
|---|---|---|
|
Change From Baseline in Epidermal Thickness as Measured by Vivosight OCT®
Change from Baseline to Day 28
|
1.79 µm
Standard Error 2.80
|
1.68 µm
Standard Error 2.22
|
|
Change From Baseline in Epidermal Thickness as Measured by Vivosight OCT®
Change from Baseline to Day 84
|
-1.93 µm
Standard Error 3.64
|
-0.51 µm
Standard Error 2.77
|
SECONDARY outcome
Timeframe: Baseline (D0) to D28 and D84Population: 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.
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.
Outcome measures
| Measure |
Juvéderm® VOLITE Treated Zone
n=11 Participants
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.
|
Non-Treated Zone
n=11 Participants
The not-treated zone of the same arm in same the participant served as a control.
|
|---|---|---|
|
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
|
0.04 mm^-1
Standard Error 0.08
|
|
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
|
0.18 mm^-1
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Baseline (D0) to D28 and D84Population: 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.
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.
Outcome measures
| Measure |
Juvéderm® VOLITE Treated Zone
n=11 Participants
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.
|
Non-Treated Zone
n=11 Participants
The not-treated zone of the same arm in same the participant served as a control.
|
|---|---|---|
|
Change From Baseline in Plexus Depth as Measured by Vivosight OCT®
Change from Baseline to Day 28
|
-11.54 µm
Standard Error 4.89
|
-6.45 µm
Standard Error 6.52
|
|
Change From Baseline in Plexus Depth as Measured by Vivosight OCT®
Change from Baseline to Day 84
|
-13.81 µm
Standard Error 5.07
|
-20.55 µm
Standard Error 6.84
|
SECONDARY outcome
Timeframe: Baseline (D0) to D28 and D84Population: 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.
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.
Outcome measures
| Measure |
Juvéderm® VOLITE Treated Zone
n=11 Participants
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.
|
Non-Treated Zone
n=11 Participants
The not-treated zone of the same arm in same the participant served as a control.
|
|---|---|---|
|
Change From Baseline in Vessel Diameter as Measured by Vivosight OCT®
Change from Baseline to Day 28
|
2.59 µm
Standard Error 2.42
|
-0.18 µm
Standard Error 2.62
|
|
Change From Baseline in Vessel Diameter as Measured by Vivosight OCT®
Change from Baseline to Day 84
|
3.66 µm
Standard Error 2.35
|
-6.33 µm
Standard Error 2.63
|
SECONDARY outcome
Timeframe: Baseline (D0) to D28 and D84Population: 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.
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.
Outcome measures
| Measure |
Juvéderm® VOLITE Treated Zone
n=11 Participants
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.
|
Non-Treated Zone
n=11 Participants
The not-treated zone of the same arm in same the participant served as a control.
|
|---|---|---|
|
Change From Baseline in Vessel Density as Measured by Vivosight OCT®
Change from Baseline to Day 28
|
0.47 dimensionless
Standard Error 0.50
|
-0.23 dimensionless
Standard Error 0.47
|
|
Change From Baseline in Vessel Density as Measured by Vivosight OCT®
Change from Baseline to Day 84
|
0.19 dimensionless
Standard Error 0.31
|
-0.36 dimensionless
Standard Error 0.30
|
SECONDARY outcome
Timeframe: Baseline (D0) to D28 and D84Population: 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.
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.
Outcome measures
| Measure |
Juvéderm® VOLITE Treated Zone
n=11 Participants
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.
|
Non-Treated Zone
n=11 Participants
The not-treated zone of the same arm in same the participant served as a control.
|
|---|---|---|
|
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
|
0.17 dimensionless
Standard Error 0.31
|
|
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
|
0.33 dimensionless
Standard Error 0.34
|
SECONDARY outcome
Timeframe: Baseline (D0) to D28 and D84Population: 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.
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.
Outcome measures
| Measure |
Juvéderm® VOLITE Treated Zone
n=11 Participants
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.
|
Non-Treated Zone
n=11 Participants
The not-treated zone of the same arm in same the participant served as a control.
|
|---|---|---|
|
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
|
0.3 glossymeter unit
Standard Error 0.1
|
|
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
|
0.2 glossymeter unit
Standard Error 0.2
|
SECONDARY outcome
Timeframe: Baseline (D0) to D28 and D84Population: 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.
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.
Outcome measures
| Measure |
Juvéderm® VOLITE Treated Zone
n=11 Participants
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.
|
Non-Treated Zone
n=11 Participants
The not-treated zone of the same arm in same the participant served as a control.
|
|---|---|---|
|
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
|
-0.1 arbitrary units
Standard Error 0.2
|
|
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
|
-0.7 arbitrary units
Standard Error 0.2
|
|
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
|
-0.2 arbitrary units
Standard Error 0.2
|
|
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
|
-1.1 arbitrary units
Standard Error 0.4
|
|
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
|
0.8 arbitrary units
Standard Error 0.3
|
|
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
|
1.1 arbitrary units
Standard Error 0.3
|
SECONDARY outcome
Timeframe: Baseline (D0) to D28 and D84Population: 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.
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.
Outcome measures
| Measure |
Juvéderm® VOLITE Treated Zone
n=11 Participants
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.
|
Non-Treated Zone
n=11 Participants
The not-treated zone of the same arm in same the participant served as a control.
|
|---|---|---|
|
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
|
2.0 degree
Standard Error 0.5
|
|
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
|
4.0 degree
Standard Error 1.0
|
SECONDARY outcome
Timeframe: Baseline (D0) to D28 and D84Population: 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.
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.
Outcome measures
| Measure |
Juvéderm® VOLITE Treated Zone
n=11 Participants
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.
|
Non-Treated Zone
n=11 Participants
The not-treated zone of the same arm in same the participant served as a control.
|
|---|---|---|
|
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
|
-8.13 arbitrary units
Standard Error 3.34
|
|
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
|
-19.79 arbitrary units
Standard Error 5.47
|
SECONDARY outcome
Timeframe: Day 0Population: Safety Population included any participant having used the tested device.
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.
Outcome measures
| Measure |
Juvéderm® VOLITE Treated Zone
n=11 Participants
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.
|
Non-Treated Zone
The not-treated zone of the same arm in same the participant served as a control.
|
|---|---|---|
|
Number of Participants With Injection Site Reactions (ISR)
Redness/Erythema: Mild
|
11 Participants
|
—
|
|
Number of Participants With Injection Site Reactions (ISR)
Pain/Tenderness: None
|
4 Participants
|
—
|
|
Number of Participants With Injection Site Reactions (ISR)
Pain/Tenderness: Mild
|
7 Participants
|
—
|
|
Number of Participants With Injection Site Reactions (ISR)
Induration: None
|
11 Participants
|
—
|
|
Number of Participants With Injection Site Reactions (ISR)
Swelling/Oedema: None
|
4 Participants
|
—
|
|
Number of Participants With Injection Site Reactions (ISR)
Swelling/Oedema: Mild
|
7 Participants
|
—
|
|
Number of Participants With Injection Site Reactions (ISR)
Lumps/Bumps: None
|
3 Participants
|
—
|
|
Number of Participants With Injection Site Reactions (ISR)
Lumps/Bumps: Mild
|
8 Participants
|
—
|
|
Number of Participants With Injection Site Reactions (ISR)
Bruising/Hematoma: None
|
4 Participants
|
—
|
|
Number of Participants With Injection Site Reactions (ISR)
Bruising/Hematoma: Mild
|
6 Participants
|
—
|
|
Number of Participants With Injection Site Reactions (ISR)
Bruising/Hematoma: Moderate
|
1 Participants
|
—
|
|
Number of Participants With Injection Site Reactions (ISR)
Itching: None
|
11 Participants
|
—
|
|
Number of Participants With Injection Site Reactions (ISR)
Discoloration/Pigmentation: None
|
11 Participants
|
—
|
Adverse Events
Juvéderm® VOLITE Treated Zone
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Juvéderm® VOLITE Treated Zone
n=11 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
9.1%
1/11 • First dose of study treatment to end of the study (Up to 9 months)
All-Cause Mortality included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Population included any participant having used the tested device.
|
|
Gastrointestinal disorders
Toothache
|
9.1%
1/11 • First dose of study treatment to end of the study (Up to 9 months)
All-Cause Mortality included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Population included any participant having used the tested device.
|
|
General disorders
Oedema
|
27.3%
3/11 • First dose of study treatment to end of the study (Up to 9 months)
All-Cause Mortality included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Population included any participant having used the tested device.
|
|
General disorders
Pain
|
18.2%
2/11 • First dose of study treatment to end of the study (Up to 9 months)
All-Cause Mortality included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Population included any participant having used the tested device.
|
|
Infections and infestations
Herpes virus infection
|
9.1%
1/11 • First dose of study treatment to end of the study (Up to 9 months)
All-Cause Mortality included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Population included any participant having used the tested device.
|
|
Infections and infestations
Oral herpes
|
9.1%
1/11 • First dose of study treatment to end of the study (Up to 9 months)
All-Cause Mortality included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Population included any participant having used the tested device.
|
|
Injury, poisoning and procedural complications
Contusion
|
18.2%
2/11 • First dose of study treatment to end of the study (Up to 9 months)
All-Cause Mortality included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Population included any participant having used the tested device.
|
|
Nervous system disorders
Burning sensation
|
9.1%
1/11 • First dose of study treatment to end of the study (Up to 9 months)
All-Cause Mortality included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Population included any participant having used the tested device.
|
|
Nervous system disorders
Headache
|
18.2%
2/11 • First dose of study treatment to end of the study (Up to 9 months)
All-Cause Mortality included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Population included any participant having used the tested device.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
18.2%
2/11 • First dose of study treatment to end of the study (Up to 9 months)
All-Cause Mortality included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Population included any participant having used the tested device.
|
|
Skin and subcutaneous tissue disorders
Skin tightness
|
18.2%
2/11 • First dose of study treatment to end of the study (Up to 9 months)
All-Cause Mortality included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Population included any participant having used the tested device.
|
|
Vascular disorders
Haematoma
|
9.1%
1/11 • First dose of study treatment to end of the study (Up to 9 months)
All-Cause Mortality included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Population included any participant having used the tested device.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER