N/A
N=11
A Study to Evaluate The Impact on Skin Quality Attributes by Juvederm® Volite Injection on Healthy Volunteers
Healthy Adults · Skin Enhancement
Bottom Line
View on ClinicalTrials.gov: NCT04206293 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: Primary: Change From Baseline in Skin Hydration as Measured by MoistureMeterD® 0.5 mm — 1.7; -0.0; 1.2; 0.6 tissue dielectric constant — p=0.0736
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Juvederm® VOLITE (Device)
- Age
- Adult · 30+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Skin Hydration as Measured by MoistureMeterD® 0.5 mm |
1.7; -0.0; 1.2; 0.6 | 0.0736 |
| PRIMARY Change From Baseline in Skin Hydration as Measured by MoistureMeter D® 1.5 mm |
0.8; 1.0; 1.4; 1.4 | 0.8848 |
| PRIMARY Change From Baseline in Skin Hydration as Measured by Corneometer® |
1.3; -1.4; 2.5; 0.1 | 0.0007 sig |
| 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 ® |
-0.092; 0.003; -0.073; -0.003; -0.094; -0.005 | <0.0001 sig |
| PRIMARY Change From Baseline in Relative Parameters of Skin Elasticity: Q1, Q2, Q3 as Measured by Cutometer ® |
-0.025; -0.017; -0.042; -0.018; -0.045; -0.023 | 0.5786 |
| PRIMARY Number of Participants With at Least One Treatment-emergent Adverse Event (AE) |
5 | — |
| SECONDARY Change From Baseline in Skin Elasticity as Measured by Elastimeter® |
4.45; 5.00; 3.90; 4.32 | 0.8409 |
| SECONDARY Change From Baseline in Skin Thickness as Measured by Skin Scanner® |
56; -14; -85; -3 | 0.4128 |
| SECONDARY Change From Baseline in Skin Density as Measured by Skin Scanner® |
4.69; -1.83; 8.56; 3.00 | 0.0798 |
| SECONDARY Change From Baseline in Skin Roughness as Measured by Vivosight OCT® |
-0.94; -1.90; -0.27; -1.37; -3.95; -9.85 | 0.2592 |
| SECONDARY Change From Baseline in Epidermal Thickness as Measured by Vivosight OCT® |
1.79; 1.68; -1.93; -0.51 | 0.9608 |
| SECONDARY Change From Baseline in Optical Attenuation Coefficient (OAC) as Measured by Vivosight OCT® |
0.02; 0.04; 0.07; 0.18 | 0.8322 |
| SECONDARY Change From Baseline in Plexus Depth as Measured by Vivosight OCT® |
-11.54; -6.45; -13.81; -20.55 | 0.5221 |
| SECONDARY Change From Baseline in Vessel Diameter as Measured by Vivosight OCT® |
2.59; -0.18; 3.66; -6.33 | 0.3052 |
| SECONDARY Change From Baseline in Vessel Density as Measured by Vivosight OCT® |
0.47; -0.23; 0.19; -0.36 | 0.1672 |
| SECONDARY Change From Baseline in 300 μm Density as Measured by Vivosight OCT® |
0.75; 0.17; 0.13; 0.33 | 0.0577 |
| SECONDARY Change From Baseline in Skin Brightness Index as Measured by Glossymeter® |
0.1; 0.3; 0.4; 0.2 | 0.2666 |
| SECONDARY Change From Baseline in Skin Colour as Measured by Spectrophotometer® |
-0.3; -0.1; 0.8; -0.7; -0.3; -0.2 | 0.4197 |
| SECONDARY Change From Baseline in Individual Typological Angle (ITA°) as Measured by Spectrophotometer® |
1.4; 2.0; 3.8; 4.0 | 0.1977 |
| SECONDARY Change From Baseline in Skin Melanin Index as Measured by Mexameter® |
-3.78; -8.13; -2.53; -19.79 | 0.2905 |
| SECONDARY Number of Participants With Injection Site Reactions (ISR) |
11; 4; 7; 11; 4; 7 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04206293). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.