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

NCT04390581 | Completed Phase 4

• 1 other identifier: MED-MA-FAS-0628
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Skin Depressions; Skin Elasticity; Skin Laxity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Improvement from baseline to each other post-treatment time points in the Allergan Hand Volume Deficit Scale (AHVDS).

  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

  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

  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

  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

  Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18

Study Arms (1)

Juvéderm® VOLIFT with Lidocaine

EXPERIMENTAL

All participants to be injected with Juvéderm® VOLIFT with Lidocaine in both hands no more than 6ml total per both hands. Optional touch-up will be done on Day 30 according to aesthetic results.

Device: Juvéderm® VOLIFT with Lidocaine

Interventions

Juvéderm® VOLIFT with Lidocaine DEVICE

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.

Juvéderm® VOLIFT with Lidocaine

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Eurofins Pharmascan /ID# 233683

Lyon, 69100, France

Location

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• ALLERGAN INC.

  Allergan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: May 15, 2020
• Study Start: May 20, 2020
• Primary Completion: December 6, 2022
• Study Completion: December 6, 2022
• Last Updated: December 12, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

FR (1)