Adults 30 to 50, any sex, with Healthy Adults or Skin Enhancement. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in Skin Hydration as Measured by MoistureMeterD® 0.5 mmPrimary· 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 sam
Change from Baseline to Day 28
Group
Value
95% CI
Juvéderm® VOLITE Treated Zone
1.7
± 0.8
Non-Treated Zone
-0.0
± 0.7
Change from Baseline to Day 84
Group
Value
95% CI
Juvéderm® VOLITE Treated Zone
1.2
± 0.9
Non-Treated Zone
0.6
± 0.8
Change From Baseline in Skin Hydration as Measured by MoistureMeter D® 1.5 mmPrimary· 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 to Day 28
Group
Value
95% CI
Juvéderm® VOLITE Treated Zone
0.8
± 1.3
Non-Treated Zone
1.0
± 1.0
Change from Baseline to Day 84
Group
Value
95% CI
Juvéderm® VOLITE Treated Zone
1.4
± 0.9
Non-Treated Zone
1.4
± 0.6
Change From Baseline in Skin Hydration as Measured by Corneometer®Primary· 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 wa
Change from Baseline to Day 28
Group
Value
95% CI
Juvéderm® VOLITE Treated Zone
1.3
± 1.1
Non-Treated Zone
-1.4
± 1.0
Change from Baseline to Day 84
Group
Value
95% CI
Juvéderm® VOLITE Treated Zone
2.5
± 1.2
Non-Treated Zone
0.1
± 1.2
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 ®Primary· 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
Uf: Change from Baseline to Day 28
Group
Value
95% CI
Juvéderm® VOLITE Treated Zone
-0.092
± 0.009
Non-Treated Zone
0.003
± 0.008
Uf: Change from Baseline to Day 84
Group
Value
95% CI
Juvéderm® VOLITE Treated Zone
-0.073
± 0.009
Non-Treated Zone
-0.003
± 0.007
Ue: Change from Baseline to Day 28
Group
Value
95% CI
Juvéderm® VOLITE Treated Zone
-0.094
± 0.010
Non-Treated Zone
-0.005
± 0.013
Ue: Change from Baseline to Day 84
Group
Value
95% CI
Juvéderm® VOLITE Treated Zone
-0.075
± 0.008
Non-Treated Zone
0.006
± 0.009
Ur: Change from Baseline to Day 28
Group
Value
95% CI
Juvéderm® VOLITE Treated Zone
-0.097
± 0.015
Non-Treated Zone
-0.018
± 0.020
Ur: Change from Baseline to Day 84
Group
Value
95% CI
Juvéderm® VOLITE Treated Zone
-0.096
± 0.012
Non-Treated Zone
-0.022
± 0.015
Ua: Change from Baseline to Day 28
Group
Value
95% CI
Juvéderm® VOLITE Treated Zone
-0.090
± 0.015
Non-Treated Zone
-0.009
± 0.015
Ua: Change from Baseline to Day 84
Group
Value
95% CI
Juvéderm® VOLITE Treated Zone
-0.093
± 0.011
Non-Treated Zone
-0.016
± 0.010
Change From Baseline in Relative Parameters of Skin Elasticity: Q1, Q2, Q3 as Measured by Cutometer ®Primary· 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
Q1: Change from Baseline to Day 28
Group
Value
95% CI
Juvéderm® VOLITE Treated Zone
-0.025
± 0.015
Non-Treated Zone
-0.017
± 0.013
Q1: Change from Baseline to Day 84
Group
Value
95% CI
Juvéderm® VOLITE Treated Zone
-0.042
± 0.012
Non-Treated Zone
-0.018
± 0.011
Q2: Change from Baseline to Day 28
Group
Value
95% CI
Juvéderm® VOLITE Treated Zone
-0.045
± 0.017
Non-Treated Zone
-0.023
± 0.018
Q2: Change from Baseline to Day 84
Group
Value
95% CI
Juvéderm® VOLITE Treated Zone
-0.053
± 0.014
Non-Treated Zone
-0.019
± 0.015
Q3: Change from Baseline to Day 28
Group
Value
95% CI
Juvéderm® VOLITE Treated Zone
0.019
± 0.006
Non-Treated Zone
0.006
± 0.007
Q3: Change from Baseline to Day 84
Group
Value
95% CI
Juvéderm® VOLITE Treated Zone
0.013
± 0.005
Non-Treated Zone
0.001
± 0.006
Change From Baseline in Skin Elasticity as Measured by Elastimeter®Secondary· 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 to Day 28
Group
Value
95% CI
Juvéderm® VOLITE Treated Zone
4.45
± 2.12
Non-Treated Zone
5.00
± 2.30
Change from Baseline to Day 84
Group
Value
95% CI
Juvéderm® VOLITE Treated Zone
3.90
± 3.20
Non-Treated Zone
4.32
± 3.49
Change From Baseline in Skin Thickness as Measured by Skin Scanner®Secondary· 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 to Day 28
Group
Value
95% CI
Juvéderm® VOLITE Treated Zone
56
± 72
Non-Treated Zone
-14
± 35
Change from Baseline to Day 84
Group
Value
95% CI
Juvéderm® VOLITE Treated Zone
-85
± 74
Non-Treated Zone
-3
± 36
Change From Baseline in Skin Density as Measured by Skin Scanner®Secondary· 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 to Day 28
Group
Value
95% CI
Juvéderm® VOLITE Treated Zone
4.69
± 2.82
Non-Treated Zone
-1.83
± 2.31
Change from Baseline to Day 84
Group
Value
95% CI
Juvéderm® VOLITE Treated Zone
8.56
± 2.65
Non-Treated Zone
3.00
± 2.27
Change From Baseline in Skin Roughness as Measured by Vivosight OCT®Secondary· 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
Ra: Change from Baseline to Day 28
Group
Value
95% CI
Juvéderm® VOLITE Treated Zone
-0.94
± 0.64
Non-Treated Zone
-1.90
± 0.63
Ra: Change from Baseline to Day 84
Group
Value
95% CI
Juvéderm® VOLITE Treated Zone
-0.27
± 0.53
Non-Treated Zone
-1.37
± 0.54
Rz: Change from Baseline to Day 28
Group
Value
95% CI
Juvéderm® VOLITE Treated Zone
-3.95
± 3.59
Non-Treated Zone
-9.85
± 3.53
Rz: Change from Baseline to Day 84
Group
Value
95% CI
Juvéderm® VOLITE Treated Zone
-3.64
± 3.26
Non-Treated Zone
-11.86
± 3.35
Change From Baseline in Epidermal Thickness as Measured by Vivosight OCT®Secondary· 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 to Day 28
Group
Value
95% CI
Juvéderm® VOLITE Treated Zone
1.79
± 2.80
Non-Treated Zone
1.68
± 2.22
Change from Baseline to Day 84
Group
Value
95% CI
Juvéderm® VOLITE Treated Zone
-1.93
± 3.64
Non-Treated Zone
-0.51
± 2.77
Change From Baseline in Optical Attenuation Coefficient (OAC) as Measured by Vivosight OCT®Secondary· 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.
Change from Baseline to Day 28
Group
Value
95% CI
Juvéderm® VOLITE Treated Zone
0.02
± 0.09
Non-Treated Zone
0.04
± 0.08
Change from Baseline to Day 84
Group
Value
95% CI
Juvéderm® VOLITE Treated Zone
0.07
± 0.07
Non-Treated Zone
0.18
± 0.07
Change From Baseline in Plexus Depth as Measured by Vivosight OCT®Secondary· 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 to Day 28
Group
Value
95% CI
Juvéderm® VOLITE Treated Zone
-11.54
± 4.89
Non-Treated Zone
-6.45
± 6.52
Change from Baseline to Day 84
Group
Value
95% CI
Juvéderm® VOLITE Treated Zone
-13.81
± 5.07
Non-Treated Zone
-20.55
± 6.84
Adverse events — posted to ClinicalTrials.gov
Time frame: First dose of study treatment to end of the study (Up to 9 months).
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Allergan
Last refreshed: 26 August 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04206293.