Prospective, Open-Label Study, to Evaluate The Impact on Skin Quality Attributes by Juvederm® Volite Injection on Healthy Volunteers
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Healthy Adults
- Sponsor
- Allergan
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Skin Hydration as Measured by MoistureMeterD® 0.5 mm
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
To evaluate the impact on skin quality attributes, including physical measurements and gene and protein expression (histological and genomic analysis), following administration of Juvéderm® VOLITE in the volar forearms of healthy volunteers.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy participants
- •Participants with Fitzpatrick skin type II or III
- •Participant willing to receive Juvéderm® VOLITE in the forearms and agrees to complete all study required procedures, including having 6 cutaneous punch biopsies taken in the forearms and blood drawn (Human immunodeficiency virus \[HIV\], B and C hepatitis analysis at screening)
- •Written informed consent and data privacy consent obtained
Exclusion Criteria
- •Pregnant or nursing woman or planning a pregnancy during the study
- •Participant participating to another research on human beings or being in an exclusion period for a previous study
- •Intensive exposure to sunlight or ultraviolet (UV)-rays within the previous month and foreseen during the study
- •Participant having other resorbable filling product injections, a laser treatment, an ultrasound-based treatment, radiation treatment, a dermabrasion, a surgery, a deep chemical peeling or other ablative procedure on the studied zones within the past 12 months prior to study start
- •Participant with subcutaneous retaining structure on the studied zones (meshing, threads, gold strand)
- •Participant having received injections of permanent or semi-permanent filling products in the studied zones
- •Participant under anti-coagulant treatment or treatment liable to interfere with the healing process or hemostasis, during the previous month and during the study
- •Participant receiving or is planning to receive anti-inflammatory drugs (oral/injectable corticosteroids or Nonsteroidal anti-inflammatory drugs (NSAIDs), e.g., aspirin, ibuprofen), or other substances known to increase coagulation time (herbal supplements with garlic or ginkgo biloba, etc) for 10 days prior to study treatment and 3 days after
- •Participant under immunosuppressive therapy
Outcomes
Primary Outcomes
Change From Baseline in Skin Hydration as Measured by MoistureMeterD® 0.5 mm
Time Frame: Baseline [Day 0 (D0)] to Days 28 (D28) and 84 (D84)
Skin hydration was measured using MoistureMeterD® XS (for epidermis and dermis), a non-invasive probe which measures the dielectric constant of the skin at a depth of 0.5 mm. 5 measurements were done on the same zone and the average value was calculated, expressed as tissue dielectric constant (TDC). The TDC is directly proportional to the amount of water in the tissue. A positive change from Baseline indicates better skin hydration. Values were obtained from a mixed analysis of variance (ANOVA) model. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.
Change From Baseline in Skin Hydration as Measured by MoistureMeter D® 1.5 mm
Time Frame: Baseline (D0) to D28 and D84
Skin hydration was measured using MoistureMeter D® S15 (for epidermis and dermis), a non-invasive probe which measures the dielectric constant of the skin at a depth of 1.5 mm. 5 measurements were done on the same zone and the average value was calculated, expressed as TDC. The TDC is directly proportional to the amount of water in the tissue. A positive change from Baseline indicates better skin hydration. Values were obtained from a mixed ANOVA model. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.
Change From Baseline in Relative Parameters of Skin Elasticity: Q1, Q2, Q3 as Measured by Cutometer ®
Time Frame: Baseline (D0) to D28 and D84
The parameters evaluated were: Elastic Recovery (Q1)=elastic recovery area (QE)/maximum recovery area (QO), Viscous Recovery (Q2)=viscous recovery area (QR)/maximum recovery area (QO) and Viscoelastic Recovery (Q3)= (QE+QR)/QO. 2 measurements were done on the same zone and the average value was calculated. Values were obtained from a mixed ANOVA model. A negative change from Baseline in Q1 and Q2 indicates decreased skin elasticity. A positive change from Baseline in Q3 indicates decreased skin elasticity. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.
Number of Participants With at Least One Treatment-emergent Adverse Event (AE)
Time Frame: First dose of study treatment to end of the study (Up to 9 months)
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A treatment-emergent AE is an AE that occurs or worsens after a participant receives study drug.
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 ®
Time Frame: Baseline (D0) to D28 and D84
Skin elasticity was measured by a Cutometer ® which uses an in vivo non-invasive method to evaluate biological extensibility and elasticity variations. The various parameters analysed were Uf: final deformation (firmness), Ue: immediate extensibility, Ur: immediate retraction (tonicity), Ua: total recovery of the initial state. 2 measurements were done on the same zone and the average value was calculated. Values were obtained from a mixed ANOVA model. A Negative change from Baseline indicates firmer skin. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.
Change From Baseline in Skin Hydration as Measured by Corneometer®
Time Frame: Baseline (D0) to D28 and D84
Corneometer® measures the hydration level of the superficial skin surface (epidermis). The measurement is based on capacitance measurement of a dielectric medium in this case skin. It uses fringing field capacitance sensors to measure the dielectric constant of the skin. The dielectric constant of skin will change with water content. This allows for any changes in skin hydration to be measured by the precision measuring capacitor. These changes in water content of the stratum corneum are converted into arbitrary units of hydration. 5 measurements were done on the same zone and average value was calculated. Values were obtained from a mixed ANOVA model and expressed in arbitrary units. A positive change from Baseline indicates better skin hydration rate. The data is presented for area treated with Juvéderm® VOLITE and non-treated area in the same participants.
Secondary Outcomes
- Change From Baseline in Skin Density as Measured by Skin Scanner®(Baseline (D0) to D28 and D84)
- Change From Baseline in Plexus Depth as Measured by Vivosight OCT®(Baseline (D0) to D28 and D84)
- Change From Baseline in Skin Thickness as Measured by Skin Scanner®(Baseline (D0) to D28 and D84)
- Change From Baseline in Skin Roughness as Measured by Vivosight OCT®(Baseline (D0) to D28 and D84)
- Change From Baseline in Skin Elasticity as Measured by Elastimeter®(Baseline (D0) to D28 and D84)
- Change From Baseline in Epidermal Thickness as Measured by Vivosight OCT®(Baseline (D0) to D28 and D84)
- Change From Baseline in Skin Melanin Index as Measured by Mexameter®(Baseline (D0) to D28 and D84)
- Change From Baseline in Skin Colour as Measured by Spectrophotometer®(Baseline (D0) to D28 and D84)
- Change From Baseline in Individual Typological Angle (ITA°) as Measured by Spectrophotometer®(Baseline (D0) to D28 and D84)
- Change From Baseline in Optical Attenuation Coefficient (OAC) as Measured by Vivosight OCT®(Baseline (D0) to D28 and D84)
- Change From Baseline in 300 μm Density as Measured by Vivosight OCT®(Baseline (D0) to D28 and D84)
- Change From Baseline in Vessel Diameter as Measured by Vivosight OCT®(Baseline (D0) to D28 and D84)
- Change From Baseline in Vessel Density as Measured by Vivosight OCT®(Baseline (D0) to D28 and D84)
- Change From Baseline in Skin Brightness Index as Measured by Glossymeter®(Baseline (D0) to D28 and D84)
- Number of Participants With Injection Site Reactions (ISR)(Day 0)