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

NCT ID: NCT04390581

Last Updated: 2022-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-20
• Study Completion Date: 2022-12-06

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Juvéderm® VOLIFT with Lidocaine

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.

Group Type: EXPERIMENTAL

Juvéderm® VOLIFT with Lidocaine

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allergan

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ALLERGAN INC.

Role: STUDY_DIRECTOR

Allergan

Locations

Eurofins Pharmascan /ID# 233683

Lyon, , France

Countries

France

Other Identifiers

MED-MA-FAS-0628

Identifier Type: -

Identifier Source: org_study_id