A Study to Evaluate The Impact on Skin Quality Attributes by Juvederm® Volite Injection on Healthy Volunteers

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.