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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Juvéderm® VOLITE | Experimental | Participants received Juvéderm® VOLITE, intradermal injection on a zone of 8 centimeter (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 milliliter (mL) was injected on the zone treated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Juvederm® VOLITE | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline [Day 0 (D0)] to Days 28 (D28) and 84 (D84) |
| 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. | Baseline (D0) to D28 and D84 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charlie Hee | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EuroFins Dermscan Poland | Gdansk | 80288 | Poland |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Full Analysis Set included any participant included in the study with at least a post-baseline value.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Least Squares Mean | Standard Error | tissue dielectric constant | Baseline [Day 0 (D0)] to Days 28 (D28) and 84 (D84) |
|
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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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area, Head | Allergan | 714-246-4500 | clinicaltrials@allergan.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 21, 2019 | Jul 29, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 16, 2020 | Jul 29, 2021 | SAP_001.pdf |
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| Baseline (D0) to D28 and D84 |
| 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. | Baseline (D0) to D28 and D84 |
| 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. | Baseline (D0) to D28 and D84 |
| 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. | First dose of study treatment to end of the study (Up to 9 months) |
| Baseline (D0) to D28 and D84 |
| 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. | Baseline (D0) to D28 and D84 |
| 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. | Baseline (D0) to D28 and D84 |
| 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. | Baseline (D0) to D28 and D84 |
| 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. | Baseline (D0) to D28 and D84 |
| 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. | Baseline (D0) to D28 and D84 |
| 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. | Baseline (D0) to D28 and D84 |
| 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. | Baseline (D0) to D28 and D84 |
| 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. | Baseline (D0) to D28 and D84 |
| 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. | Baseline (D0) to D28 and D84 |
| 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. | Baseline (D0) to D28 and D84 |
| 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. | Baseline (D0) to D28 and D84 |
| 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. | Baseline (D0) to D28 and D84 |
| 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. | Baseline (D0) to D28 and D84 |
| 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. | Day 0 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Skin Hydration (MoistureMeterD® XS Probe) | 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. | Mean | Standard Deviation | tissue dielectric constant |
|
| Skin Hydration (MoistureMeterD® S Probe) | 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. | Mean | Standard Deviation | tissue dielectric constant |
|
| Skin Hydration (Corneometer®) | Corneometer® measures the hydration level of the superficial skin surface (epidermis). 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. | Mean | Standard Deviation | arbitrary units of hydration |
|
| Skin Elasticity Parameters (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. | Mean | Standard Deviation | millimeters (mm) |
|
| Relative Parameters of Skin Elasticity (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. | Mean | Standard Deviation | dimensionless |
|
| Skin Elasticity | 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. | Mean | Standard Deviation | Newton/meter |
|
| Skin Thickness (Skin Scanner®) | Skin thickness was measured as the average thickness of the epidermis and dermis (in mm) using SkinScanner®, a high frequency echograph. | Mean | Standard Deviation | mm |
|
| Skin Density (Skin Scanner®) | Skin density was measured as the percentage of echogenic surface using SkinScanner®, a high frequency echograph. | Mean | Standard Deviation | percentage of echogenic surface |
|
| Skin Roughness (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. | Mean | Standard Deviation | micrometer (µm) |
|
| Epidermal Thickness (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. | Mean | Standard Deviation | µm |
|
| Optical Attenuation Coefficient (OAC) (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. | Mean | Standard Deviation | per mm (mm^-1) |
|
| Plexus Depth (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. | Mean | Standard Deviation | µm |
|
| Vessel Diameter (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. | Mean | Standard Deviation | µm |
|
| Vessel Density | 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. | Mean | Standard Deviation | dimensionless |
|
| 300 μm Density | 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. | Mean | Standard Deviation | dimensionless |
|
| Skin Brightness Index | 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". | Mean | Standard Deviation | glossymeter units |
|
| Skin Colour (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. | Mean | Standard Deviation | arbitrary units |
|
| Individual Typological Angle (ITA°) (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 are expressed in degree (°). | Mean | Standard Deviation | degree |
|
| Skin Melanin Index (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 in arbitrary units from 0 to 999. 3 measurements were done on the same zone and the average value was calculated. | Mean | Standard Deviation | arbitrary units |
|
| 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. |
| OG001 | Non-Treated Zone | The not-treated zone of the same arm in same the participant served as a control. |
|
|
|
| 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. | 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. | Posted | Least Squares Mean | Standard Error | tissue dielectric constant | Baseline (D0) to D28 and D84 |
|
|
|
|
| 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. | 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. | Posted | Least Squares Mean | Standard Error | arbitrary units of hydration | Baseline (D0) to D28 and D84 |
|
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| 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. | 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. | Posted | Least Squares Mean | Standard Error | mm | Baseline (D0) to D28 and D84 |
|
|
|
|
| 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. | 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. | Posted | Least Squares Mean | Standard Error | dimensionless | Baseline (D0) to D28 and D84 |
|
|
|
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| 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. | 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. | Posted | Least Squares Mean | Standard Error | Newton/meter | Baseline (D0) to D28 and D84 |
|
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|
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| 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. | 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. | Posted | Least Squares Mean | Standard Error | mm | Baseline (D0) to D28 and D84 |
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| 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. | 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. | Posted | Least Squares Mean | Standard Error | percentage of echogenic surface | Baseline (D0) to D28 and D84 |
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| 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. | 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. | Posted | Least Squares Mean | Standard Error | µm | Baseline (D0) to D28 and D84 |
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| 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. | 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. | Posted | Least Squares Mean | Standard Error | µm | Baseline (D0) to D28 and D84 |
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| 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. | 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. | Posted | Least Squares Mean | Standard Error | mm^-1 | Baseline (D0) to D28 and D84 |
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| 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. | 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. | Posted | Least Squares Mean | Standard Error | µm | Baseline (D0) to D28 and D84 |
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| 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. | 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. | Posted | Least Squares Mean | Standard Error | µm | Baseline (D0) to D28 and D84 |
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| 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. | 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. | Posted | Least Squares Mean | Standard Error | dimensionless | Baseline (D0) to D28 and D84 |
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| 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. | 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. | Posted | Least Squares Mean | Standard Error | dimensionless | Baseline (D0) to D28 and D84 |
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| 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. | 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. | Posted | Least Squares Mean | Standard Error | glossymeter unit | Baseline (D0) to D28 and D84 |
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| 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. | 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. | Posted | Least Squares Mean | Standard Error | arbitrary units | Baseline (D0) to D28 and D84 |
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| 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. | 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. | Posted | Least Squares Mean | Standard Error | degree | Baseline (D0) to D28 and D84 |
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| 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. | 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. | Posted | Least Squares Mean | Standard Error | arbitrary units | Baseline (D0) to D28 and D84 |
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| 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. | Safety Population included any participant having used the tested device. | Posted | Count of Participants | Participants | First dose of study treatment to end of the study (Up to 9 months) |
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| 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. | Safety Population included any participant having used the tested device. | Posted | Count of Participants | Participants | Day 0 |
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|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 5 |
| 11 |
| Toothache | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Pain | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Herpes virus infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Oral herpes | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Burning sensation | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Skin tightness | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
|
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.
| Change from Baseline to Day 84 |
|
|
Change from Baseline to Day 84 |
| Mixed ANOVA |
Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction. |
| 0.9505 |
| LS Mean Difference |
| -0.1 |
| Standard Error of the Mean |
| 0.8 |
| 2-Sided |
| 95 |
| -1.8 |
| 1.7 |
| Superiority |
| Change from Baseline to Day 84 |
|
|
Change from Baseline to Day 84 |
| Mixed ANOVA |
Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction. |
| 0.0033 |
| LS Mean Difference |
| 2.4 |
| Standard Error of the Mean |
| 0.7 |
| 2-Sided |
| 95 |
| 0.9 |
| 3.9 |
| Superiority |
| Uf: Change from Baseline to Day 84 |
|
|
| Ue: Change from Baseline to Day 28 |
|
|
| Ue: Change from Baseline to Day 84 |
|
|
| Ur: Change from Baseline to Day 28 |
|
|
| Ur: Change from Baseline to Day 84 |
|
|
| Ua: Change from Baseline to Day 28 |
|
|
| Ua: Change from Baseline to Day 84 |
|
|
Uf: Change from Baseline to Day 84 |
| Mixed ANOVA |
Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction. |
| <0.0001 |
| LS Mean Difference |
| -0.071 |
| Standard Error of the Mean |
| 0.011 |
| 2-Sided |
| 95 |
| -0.094 |
| -0.048 |
| Superiority |
| Ue: Change from Baseline to Day 28 | Mixed ANOVA | Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction. | <0.0001 | LS Mean Difference | -0.089 | Standard Error of the Mean | 0.013 | 2-Sided | 95 | -0.116 | -0.061 | Superiority |
| Ue: Change from Baseline to Day 84 | Mixed ANOVA | Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction. | <0.0001 | LS Mean Difference | -0.081 | Standard Error of the Mean | 0.009 | 2-Sided | 95 | -0.102 | -0.061 | Superiority |
| Ur: Change from Baseline to Day 28 | Mixed ANOVA | Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction. | 0.0003 | LS Mean Difference | -0.079 | Standard Error of the Mean | 0.018 | 95 | -0.116 | -0.041 | Superiority |
| Ur: Change from Baseline to Day 84 | Mixed ANOVA | Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction. | 0.0001 | LS Mean Difference | -0.074 | Standard Error of the Mean | 0.013 | 2-Sided | 95 | -0.103 | -0.044 | Superiority |
| Ua: Change from Baseline to Day 28 | Mixed ANOVA | Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction. | 0.0002 | LS Mean Difference | -0.081 | Standard Error of the Mean | 0.017 | 2-Sided | 95 | -0.117 | -0.045 | Superiority |
| Ua: Change from Baseline to Day 84 | Mixed ANOVA | Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction. | <0.0001 | LS Mean Difference | -0.077 | Standard Error of the Mean | 0.012 | 2-Sided | 95 | -0.103 | -0.052 | Superiority |
| Q1: Change from Baseline to Day 84 |
|
|
| Q2: Change from Baseline to Day 28 |
|
|
| Q2: Change from Baseline to Day 84 |
|
|
| Q3: Change from Baseline to Day 28 |
|
|
| Q3: Change from Baseline to Day 84 |
|
|
Q1: Change from Baseline to Day 84 |
| Mixed ANOVA |
Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction. |
| 0.0690 |
| LS Mean Difference |
| -0.023 |
| Standard Error of the Mean |
| 0.012 |
| 2-Sided |
| 95 |
| -0.049 |
| 0.002 |
| Superiority |
| Q2: Change from Baseline to Day 28 | Mixed ANOVA | Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction. | 0.1934 | LS Mean Difference | -0.021 | Standard Error of the Mean | 0.016 | 2-Sided | 95 | -0.054 | 0.012 | Superiority |
| Q2: Change from Baseline to Day 84 | Mixed ANOVA | Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction. | 0.0194 | LS Mean Difference | -0.034 | Standard Error of the Mean | 0.013 | 2-Sided | 95 | -0.062 | -0.006 | Superiority |
| Q3: Change from Baseline to Day 28 | Mixed ANOVA | Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction. | 0.0652 | LS Mean Difference | 0.013 | Standard Error of the Mean | 0.007 | 2-Sided | 95 | -0.001 | 0.028 | Superiority |
| Q3: Change from Baseline to Day 84 | Mixed ANOVA | Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction. | 0.0756 | LS Mean Difference | 0.012 | Standard Error of the Mean | 0.006 | 2-Sided | 95 | -0.001 | 0.024 | Superiority |
| Change from Baseline to Day 84 |
|
|
Change from Baseline to Day 84 |
| Mixed ANOVA |
Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction. |
| 0.9183 |
| LS Mean Difference |
| -0.42 |
| Standard Error of the Mean |
| 3.98 |
| 2-Sided |
| 95 |
| -9.18 |
| 8.35 |
| Superiority |
| Change from Baseline to Day 84 |
|
|
Change from Baseline to Day 84 |
| Mixed ANOVA |
Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction. |
| 0.3851 |
| LS Mean Difference |
| -82 |
| Standard Error of the Mean |
| 79 |
| 2-Sided |
| 95 |
| -355 |
| 191 |
| Superiority |
| Change from Baseline to Day 84 |
|
|
Change from Baseline to Day 84 |
| Mixed ANOVA |
Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction. |
| 0.1142 |
| LS Mean Difference |
| 5.56 |
| Standard Error of the Mean |
| 3.27 |
| 2-Sided |
| 95 |
| -1.55 |
| 12.67 |
| Superiority |
| Ra: Change from Baseline to Day 84 |
|
|
| Rz: Change from Baseline to Day 28 |
|
|
| Rz: Change from Baseline to Day 84 |
|
|
Ra: Change from Baseline to Day 84 |
| Mixed ANOVA |
Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction. |
| 0.1341 |
| LS Mean Difference |
| 1.09 |
| Standard Error of the Mean |
| 0.69 |
| 2-Sided |
| 95 |
| -0.38 |
| 2.57 |
| Superiority |
| Rz: Change from Baseline to Day 28 | Mixed ANOVA | Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction. | 0.2138 | LS Mean Difference | 5.91 | Standard Error of the Mean | 4.55 | 2-Sided | 95 | -3.79 | 15.61 | Superiority |
| Rz: Change from Baseline to Day 84 | Mixed ANOVA | Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction. | 0.0700 | LS Mean Difference | 8.22 | Standard Error of the Mean | 4.20 | 2-Sided | 95 | -0.77 | 17.20 | Superiority |
| Change from Baseline to Day 84 |
|
|
Change from Baseline to Day 84 |
| Mixed ANOVA |
Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction. |
| 0.6192 |
| LS Mean Difference |
| -1.42 |
| Standard Error of the Mean |
| 2.79 |
| 2-Sided |
| 95 |
| -7.48 |
| 4.64 |
| Superiority |
| Change from Baseline to Day 84 |
|
|
Change from Baseline to Day 84 |
| Mixed ANOVA |
Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction. |
| 0.1334 |
| LS Mean Difference |
| -0.11 |
| Standard Error of the Mean |
| 0.07 |
| 2-Sided |
| 95 |
| -0.25 |
| 0.04 |
| Superiority |
| Change from Baseline to Day 84 |
|
|
Change from Baseline to Day 84 |
| Mixed ANOVA |
Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction. |
| 0.4174 |
| LS Mean Difference |
| 6.74 |
| Standard Error of the Mean |
| 8.07 |
| 2-Sided |
| 95 |
| -10.55 |
| 24.03 |
| Superiority |
| Change from Baseline to Day 84 |
|
|
Change from Baseline to Day 84 |
| Mixed ANOVA |
Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction. |
| 0.0016 |
| LS Mean Difference |
| 9.99 |
| Standard Error of the Mean |
| 2.57 |
| 2-Sided |
| 95 |
| 4.48 |
| 15.50 |
| Superiority |
| Change from Baseline to Day 84 |
|
|
Change from Baseline to Day 84 |
| Mixed ANOVA |
Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction. |
| 0.0881 |
| LS Mean Difference |
| 0.55 |
| Standard Error of the Mean |
| 0.29 |
| 2-Sided |
| 95 |
| -0.10 |
| 1.21 |
| Superiority |
| Change from Baseline to Day 84 |
|
|
Change from Baseline to Day 84 |
| Mixed ANOVA |
Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction. |
| 0.5224 |
| LS Mean Difference |
| -0.20 |
| Standard Error of the Mean |
| 0.31 |
| 2-Sided |
| 95 |
| -0.85 |
| 0.45 |
| Superiority |
| Change from Baseline to Day 84 |
|
|
Change from Baseline to Day 84 |
| Mixed ANOVA |
Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction. |
| 0.4366 |
| LS Mean Difference |
| 0.2 |
| Standard Error of the Mean |
| 0.2 |
| 2-Sided |
| 95 |
| -0.3 |
| 0.7 |
| Superiority |
| a*: Change from Baseline to Day 84 |
|
|
| b*: Change from Baseline to Day 28 |
|
|
| b*: Change from Baseline to Day 84 |
|
|
| L*: Change from Baseline to Day 28 |
|
|
| L*: Change from Baseline to Day 84 |
|
|
a*: Change from Baseline to Day 84 |
| Mixed ANOVA |
Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction. |
| 0.9140 |
| LS Mean Difference |
| -0.0 |
| Standard Error of the Mean |
| 0.3 |
| 2-Sided |
| 95 |
| -0.6 |
| 0.5 |
| Superiority |
| b*: Change from Baseline to Day 28 | Mixed ANOVA | Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction. | 0.7604 | LS Mean Difference | -0.1 | Standard Error of the Mean | 0.2 | 2-Sided | 95 | -0.6 | 0.4 | Superiority |
| b*: Change from Baseline to Day 84 | Mixed ANOVA | Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction. | 0.5936 | LS Mean Difference | -0.2 | Standard Error of the Mean | 0.4 | 2-Sided | 95 | -1.0 | 0.6 | Superiority |
| L*: Change from Baseline to Day 28 | Mixed ANOVA | Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction. | 0.0808 | LS Mean Difference | -0.4 | Standard Error of the Mean | 0.2 | 2-Sided | 95 | -0.9 | 0.1 | Superiority |
| L*: Change from Baseline to Day 84 | Mixed ANOVA | Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction. | 0.1633 | LS Mean Difference | -0.4 | Standard Error of the Mean | 0.3 | 2-Sided | 95 | -1.0 | 0.2 | Superiority |
| Change from Baseline to Day 84 |
|
|
Change from Baseline to Day 84 |
| Mixed ANOVA |
Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction. |
| 0.7535 |
| LS Mean Difference |
| -0.3 |
| Standard Error of the Mean |
| 0.9 |
| 2-Sided |
| 95 |
| -2.2 |
| 1.7 |
| Superiority |
| Change from Baseline to Day 84 |
|
|
Change from Baseline to Day 84 |
| Mixed ANOVA |
Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction. |
| 0.0241 |
| LS Mean Difference |
| 17.27 |
| Standard Error of the Mean |
| 6.37 |
| 2-Sided |
| 95 |
| 2.84 |
| 31.69 |
| Superiority |
| Title | Measurements |
|---|---|
|
| Induration: None |
|
| Swelling/Oedema: None |
|
| Swelling/Oedema: Mild |
|
| Lumps/Bumps: None |
|
| Lumps/Bumps: Mild |
|
| Bruising/Hematoma: None |
|
| Bruising/Hematoma: Mild |
|
| Bruising/Hematoma: Moderate |
|
| Itching: None |
|
| Discoloration/Pigmentation: None |
|