A Study to Evaluate the Effect of Juvederm Volift With Lidocaine on Aging Hands in Participants Age 35 and Older

Skin Laxity Clinical Trial

Official title:

A Prospective Study Evaluating the Effectiveness of Juvederm Volift With Lidocaine for Treatment of the Aging Hands

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04390581
• Other study ID #: MED-MA-FAS-0628
• Status: Completed
• Phase: Phase 4
• Start date: May 20, 2020
• Est. completion date: December 6, 2022

Study information

• Verified date: December 2022
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the effect of Juvederm Volift with Lidocaine, an injectable gel implant, to treat aging hands of participants 35 and older.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 6, 2022
• Est. primary completion date: December 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

Inclusion Criteria:

• Able to provide informed consent
• Female and male subjects over 35 years of age
• Has a desire for treatment with hyaluronic acid for skin depressions on both hands
• Must qualify to receive Juvéderm® VOLIFT®™ with Lidocaine as described in the current European Union Juvéderm® VOLIFT®™ with Lidocaine Directions For Use (DFU)
• Accepts the obligation not to receive any other hand cosmetic procedures or treatments at any time during the study (hand creams are permitted)
• Agrees not to change their normal hand care regimen throughout the course of the study.
• Women of childbearing potential must have a negative urine pregnancy test result at baseline (Day 1) and practice a reliable method of contraception throughout the study.

Exclusion Criteria:

• All contraindications as described in the current European Union Juvéderm® VOLIFT®™ with Lidocaine Directions For Use (DFU), as supplied with the product.
• Receiving or planning to receive anticoagulant therapy during the course of the study, or received anticoagulant within 10 days prior to study treatment and 3 days after.
• Receiving or is planning to receive anti-inflammatory drugs (oral/injectable corticosteroids or NSAIDs, e.g., aspirin, ibuprofen), or other substances known to increase coagulation time (vitamins or herbal supplements, e.g., Vitamin E, gingko) for 10 days prior to study treatment and 3 days after
• Undergone hand surgery, tissue grafting, or tissue augmentation with silicone, fat, or other permanent, or semi-permanent dermal fillers or be planning to undergo any of these procedures at any time during the study
• Undergone temporary hand dermal filler injections with any substance within 12 months prior to entry in the study
• Noticeable scarring, active inflammation, infection, cancerous or pre-cancerous lesion, or unhealed wound or have undergone radiation treatment in the area to be treated
• Subject with a dental infection (e.g. infected tooth or paradonitis) or have received dental cleaning within one month of such infection
• Subject with history of hypertrophic scarring on hands
• Any fibrosis or scarring or deformities on the hands - History of neurological disease that may affect peripheral neurological function
• Subjects with a history of Raynaud´s disease or phenomenon, or history of other disease that may affect peripheral circulation
• Subjects with a history of autoimmune disease or joint disease or connective tissue disease (e.g., rheumatoid arthritis, lupus, scleroderma etc.)
• Woman pregnant, lactating, or planning to become pregnant at any time during the study
• Received any investigational product within 30 days prior to study enrollment or be planning to participate in another investigation during the course of this study
• Subject with any skin disease (acute and/or chronic) on the treated zone, likely to interfere with the measured parameters or to put the subject to an undue risk.
• Subject with multiple allergies, anaphylactic shock history, evolutive allergic pathologies.

Related Conditions & MeSH terms

• Cutis Laxa
• Skin Depressions
• Skin Elasticity
• Skin Laxity

Intervention

Device:
• Juvéderm® VOLIFT with Lidocaine
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.

Locations

Country	Name	City	State
France	Eurofins Pharmascan /ID# 233683	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Month 3
Secondary	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.	Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Secondary	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.	Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Secondary	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.	Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Secondary	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.	Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Secondary	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).	Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Secondary	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	Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Secondary	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	Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Secondary	Injection Site Reactions (ISRs) evaluated by the subject 30 days after each injection using a subject injection site diary.		Day 30
Secondary	Number of patients experiencing one or more treatment emergent adverse events (TEAEs)	The number of patients who experienced one more TEAEs	Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Secondary	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.	Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Secondary	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.	Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Secondary	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.	Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18