TerminatedNot Applicable

To Evaluate the Performance and Safety of YVOIRE Y Solution 360 Versus Comparator for Lips and Perioral Area.

Stopped: Due to company's internal decision.

Germany118 participantsStarted 2020-06-05

Plain-language summary

A Study to Evaluate the Performance and Safety of YVOIRE Y-Solution 360 on Lips and Perioral Area.

Who can participate

Age range

18 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: * Male or female 18 years or above age. * 1 or 2 of the 5-point (0-4) LFRS (Lip Fullness Rating Scale). * Agree to use proper contraception as guided in the protocol. * Signed for Informed Consent. Exclusion Criteria: * have lip tattoos, piercings, facial hair, or scars that would interfere with visualization of the lips and perioral area * who have dentures or any device covering all or part of the upper palate, and/or severe malocclusion or dentofacial or maxillofacial deformities * have undergone oral surgery within 6 weeks * have received permanent facial implants in the face or neck, or are planning to be implanted with any of these products * have undergone semi-permanent filler in lower face within 24 months * have undergone temporary dermal filler treatment in the lower face within 12 months * Have undergone facial tissue augmentation or facial treatment with fat or botulinum injections in the lower face within 6 months * Have undergone mesotherapy, face lift, laser, photo modulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, or other ablative procedures in face or neck within 6 months * have used lip plumping products within 10 days

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

Mean change on the overall Lip Fullness Rating Scale (LFRS) from baseline to Week12.

Timeframe: 12 weeks from baseline

Responder rate calculated using Lip Fullness Rating Scale (LFRS) for overall lip at Week12.

Timeframe: 12 weeks from baseline

Trial details

NCT IDNCT04299295

SponsorLG Chem

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-12-07

View on ClinicalTrials.gov More Lip Augmentation trials

Who can participate

Age range

18 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.