Eurofins Pharmascan /ID# 233683
Lyon, 69100, France
NCT Number: NCT04390581
This study will evaluate the effect of Juvederm Volift with Lidocaine, an injectable gel implant, to treat aging hands of participants 35 and older.
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Notify Me35 year and older
All sexes
Interventional
Phase 4
Lyon, 69100, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Month 3
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
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
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
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
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.
Time frame: Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
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
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
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
Time frame: Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
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
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
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
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.
Allergan
Industry
A Prospective Study Evaluating the Effectiveness of Juvederm Volift With Lidocaine for Treatment of the Aging Hands
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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