This study will evaluate the effect of Juvederm Volift with Lidocaine, an injectable gel implant, to treat aging hands of participants 35 and older.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
75
Consists of one injection of Juvéderm® VOLIFT with Lidocaine to both hands no more than 6ml for both hands total on Day 1. Optional on Day 30.
Eurofins Pharmascan /ID# 233683
Lyon, France
At least a 1-point improvement in the Allergan Hand Volume Deficit Scale (AHVDS) by hand from baseline before treatment to 3-month visit.
The Evaluating Investigator will grade each hand using the AHVDS 5-point scale where 0= No visible tendons and veins, 1=No protruding tendons, 2=Protruding tendons, 3=Prominent tendons, 4=Tendons very prominent.
Time frame: Month 3
Improvement from baseline to each other post-treatment time points in the Allergan Hand Volume Deficit Scale (AHVDS).
The Evaluating Investigator will grade each hand using the AHVDS 5-point scale where 0= No visible tendons and veins, 1=No protruding tendons, 2=Protruding tendons, 3=Prominent tendons, 4=Tendons very prominent.
Time frame: Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Investigator improvement from baseline to each post-treatment time point using the Global Aesthetic Improvement Scale (GAIS) Investigator
The Evaluating Investigator will assess the aesthetic improvement of the hands using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse.
Time frame: Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Subject improvement from baseline to each post-treatment time point using the Global Aesthetic Improvement Scale (GAIS) Subject
The Subject will assess the aesthetic improvement of the hands using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse.
Time frame: Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Change in HAND-Q Hand Appearance Scale from baseline before treatment to each post-treatment timepoint
The Subjects will answer the HAND-Q Hand Appearance Scale questionnaire before injection (baseline) and at each time points after injection. One questionnaire will be completed globally for both hands, taking into account the worst hand.
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Time frame: Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Change in skin roughness from baseline before treatment to each post-treatment timepoint using PRIMOS ® 3D Lite for skin roughness measurements
Measurements of skin microrelief will be performed using PRIMOS ® 3D Lite (Phaseshift Rapid In vivo Measurement Of Skin).
Time frame: Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Change in skin moisture from baseline before treatment to each post-treatment timepoint using MoistureMeter D®
MoistureMeter D® (Delfin Technologies) allows to measure water content of biological tissues
Time frame: Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Change in skin elasticity from baseline before treatment to each post-treatment timepoint using Cutometer®
MPA 580 Cutometer® (Courage \& Khazaka) is an in vivo non-invasive method to evaluate skin rheological properties: measures of biological extensibility and elasticity variations. Cutaneous skin elasticity measurement will be performed with a 6mm probe
Time frame: Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Injection Site Reactions (ISRs) evaluated by the subject 30 days after each injection using a subject injection site diary.
Time frame: Day 30
Number of patients experiencing one or more treatment emergent adverse events (TEAEs)
The number of patients who experienced one more TEAEs
Time frame: Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Change in baseline in hand function based on finger goniometer test that will be used to measure any changes in hand function at each post-treatment timepoint.
A finger goniometer measures range-of-motion (ROM) of finger joints (metacarpophalangeal and interphalangeal). To measure finger flexion and extension.
Time frame: Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Change in baseline in hand function based on hand dynamometer test that will be used to measure any changes in hand function at each post-treatment timepoint.
A hand dynamometer measures the maximum isometric strength of the hand and forearm muscles. The preferred and non-preferred hand is assessed in an alternating sequence until 3 trials had been completed per hand.
Time frame: Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Change in baseline in hand function based on pinch gauge test that will be used to measure any changes in hand function at each post-treatment timepoint.
A pinch gauge is a hand-held medical device that is used for measuring a patient's hand strength. After the first trial score is recorded, the test is repeated with the same instructions for the second and third trials and for the other hand. The scores of three successive trials for each hand tested is averaged.
Time frame: Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18