VFORM: Prospective, Open Label, Study to Evaluate VOLIFT With Lidocaine Treatment for FORehead Co… (NCT05077488) | Clinical Trial Compass
CompletedPhase 4
VFORM: Prospective, Open Label, Study to Evaluate VOLIFT With Lidocaine Treatment for FORehead Contouring and Marionette Lines
France163 participantsStarted 2021-09-15
Plain-language summary
To collect post-marketing data on Juvéderm® VOLIFT™ with Lidocaine on the following indications:
1. Marionette lines (treatment skin depressions)
2. Forehead contouring (face contouring)
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 of age or older.
. Signed the Independent Ethics Committee (IEC)-approved informed consent form prior to any studyrelated procedures being performed.
. Eligible for treatment in at least one of the following treatment areas:
. Juvéderm VOLIFT treatment of skin depressions in the marionette lines:
. Juvéderm VOLIFT treatment for irregularities of forehead contouring as assessed by the investigator and is likely to see improvement
. Accept the obligation not to receive any other facial procedures or treatments anywhere in the face during the study that are not related to the study.
. Women of childbearing potential must have a negative urine pregnancy test before each injectable treatment and practice a reliable method of contraception throughout the study.
. Ability to follow study instructions and likely to complete all required visits and assessments, as assessed by the Investigator.
Exclusion criteria
. Females who are pregnant, nursing, or planning a pregnancy.
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
1
Forehead Contouring: Proportion of subjects with a Global Aesthetic Improvement Scale (GAIS) equal to 'improved" or "much improved" as assessed by a blinded aesthetic doctor of the contouring of the forehead using a 3D image.
Timeframe: Baseline to 30 Days
2
Marionette Lines: Proportion of subjects with a ≥1-point change in the Marionette Line scale from baseline before treatment to 30 days post treatment.
. Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
. Subject in a social or sanitary establishment (socially or mentally vulnerable).
. Current enrolment in an investigational drug or device study, participation in such a study within 6 weeks before enrollment, or be planning to participate in another investigation during the course of this study.
. Is an employee (or immediate relative of an employee) of the Investigator, study staff, Allergan, or a representative of Allergan.
. In France: subject having received 4500 euros indemnities for participation in researches involving human beings in the 12 previous months, including participation in the present study.
. Has a history of multiple or severe allergies, anaphylaxis, atopy, or allergy to lidocaine, HA products, or Streptococcal protein, or is planning to undergo desensitization therapy during the study.
. Has an active inflammation or infection (acne, herpes,…), cancerous or precancerous lesion, or unhealed wound.