CompletedNot Applicable

JUVÉDERM® VOLITE™ XC for Cheek Skin Smoothness

United States, Puerto Rico209 participantsStarted 2018-11-09

Plain-language summary

This is a pivotal study to collect safety and effectiveness data on JUVÉDERM VOLITE™ XC for improvement in skin smoothness of the cheeks in order to support FDA product approval.

Who can participate

Age range

22 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: * Ability to follow study instructions and likely to complete all required visits; * Written informed consent and data privacy consent have been obtained Exclusion Criteria: * Has undergone tissue augmentation with dermal fillers including hyaluronic acid (HA), calcium hydroxylapatite, autologous fat, mesotherapy, or other cosmetic procedures (eg, face-lift, laser, photomodulation, intense pulsed light, radiofrequency, dermabrasion, chemical peel, or other ablative procedures) in the fact within 12 months before screening or is planning to undergo any such treatment during the study; * Has received any crosslinked HA filler in any anatomic area within 12 months of screening; * Has undergone treatment with botulinum toxin in the cheek area (including crow's feet) within 6 months of screening or is planning to undergo such treatment during the study; * Has ever received semi-permanent fillers or permanent facial implants (eg, poly-L-lactic acid, polymethylmethacrylate, silicone, expanded polytetrafuoroethylene) anywhere in the face or is planning to be implanted with any of these products at any time during the study; * Has facial tattoos, piercings, pigmentation, hair (ie, beard, mustache), or past trauma that would interfere with the visualization of the face for the effectiveness assessments; * Has undergone a dental procedure within 6 weeks before treatment or plans to undergo a dental procedure (other than prophylasix or dental fillings) during the c…

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

Percentage of Participants With at Least 1-point Improvement (Decrease) From Baseline on the Allergan Cheek Smoothness Scale (ACSS) on Both Cheeks at Month 1

Timeframe: Baseline to Month 1

Number of Participants Who Experience One or More Treatment Emergent Adverse Event (TEAE)

Timeframe: From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months)

Trial details

NCT IDNCT03728309

SponsorAllergan

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-07-17

Results submitted2022-10-13

View on ClinicalTrials.gov More Skin Smoothness of the Cheeks trials