CompletedPhase 3

A Study to Assess Adverse Events and Effectiveness of Intradermally Injected JUVÉDERM® VOLITE™ Gel Filler in Adult Participants in China With Fine Lines Around the Mouth

China198 participantsStarted 2022-09-07

Plain-language summary

Facial fine lines and wrinkles are caused by skin thinning, loss of moisture, and loss of elasticity due to factors such as age, ultraviolet (UV) radiation, and environmental exposures. Today, many injectable fillers are used to treat facial aging and correct skin defects. In this study, adverse effects and effectiveness of JUVÉDERM® VOLITE™ will be assessed in correcting perioral lines (around the mouth). VOLITE is an investigational device being developed for the correction of perioral lines. In this study, participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to the no-treatment control group. Adult participants seeking improvement of lines, hydration, and skin smoothness in perioral area will be enrolled. Around 198 participants will be enrolled in the study at approximately 12 sites in China. Participants in the treatment group will receive the initial injection of VOLITE; the control group will receive no treatment, but will have the opportunity to receive VOLITE after 2 months. Participants will be followed up for 12 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend monthly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects, and completing questionnaires.

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: * Has moderate or severe perioral lines (Perioral Lines at Rest Severity Scale \[POLSS\] Grades 2 or 3) as assessed by the Evaluating Investigator (EI). * Participants seeking improvement of lines, hydration, and skin smoothness in perioral area. * Is able to achieve a 1-point improvement in POLSS score in the judgment of Treating Investigator (TI). * Participant must be in good health as determined by medical history, vital signs, and TI's judgment, including no known active pandemic infection. Exclusion Criteria: * Has a history of anaphylaxis, atopy, or allergy to lidocaine, hyaluronic acid (HA) products, or Streptococcal protein, or is planning to undergo desensitization therapy during the study. * Has current cutaneous inflammatory or infectious processes (e.g., acne, herpes), abscess, an unhealed wound, angioneurotic edema, cheilitis, or a cancerous or precancerous lesion in the perioral area that could interfere with effectiveness assessments. * Has a tendency to develop hypertrophic scarring. * Has impaired cardiac conduction, severely impaired hepatic function, or severe renal dysfunction. * Has a history of anaphylactic shock. * Have a history of or currently suffer from autoimmune disease (e.g., rheumatoid arthritis, Crohn's disease) other than Hashimoto's thyroiditis. * Has porphyria. * Has a history of skin cancer. * Has ever received permanent facial implants (e.g., polymethylmethacrylate, silicone, polytetrafluoroethylene) below the subna…

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

The percentage of participants who achieved at least 1-point improvement from baseline on the Perioral Lines Severity Scale (POLSS)

Timeframe: Up to Month 2

Trial details

NCT IDNCT05454033

SponsorAbbVie

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-09-03

View on ClinicalTrials.gov More Perioral Lines trials