CompletedPhase 4

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

France75 participantsStarted 2020-05-20

Plain-language 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.

Who can participate

Age range

35 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

At least a 1-point improvement in the Allergan Hand Volume Deficit Scale (AHVDS) by hand from baseline before treatment to 3-month visit.

Timeframe: Month 3

Trial details

NCT IDNCT04390581

SponsorAllergan

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-12-06

View on ClinicalTrials.gov More Skin Depressions trials

Who can participate

Age range

35 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.