Evaluation of the Long Term Efficacy and Tolerability of ART FILLER® Volume and Lips (NCT05456971) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of the Long Term Efficacy and Tolerability of ART FILLER® Volume and Lips
104 participantsStarted 2016-09-12
Plain-language summary
The function of injectable fillers for the treatment of dermal contour deformities is to smooth dermal depressions formed by the loss of volume. These fillers (also known as soft tissue augmentation devices) can restore the age-related volume loss of the face, balance the disproportions or correct topographical anomalies. Art Filler® Volume and Art Filler Lips are two hyaluronic-based fillers. Both contain 0.3% lidocaine hydrochloride for its anaesthetic properties. The difference between the two devices lies in their viscosity, which must be adapted for the regions being treated and to restoring facial volumes. Midface for Art Filler® Volume and Lips for Art filler® Lips. On this background, a study is conducted to evaluate the long term efficacy and tolerability of Art Filler® Volume and Art Filler® Lips. It is a prospective, non-comparative, multicentre study with long term evaluation (18 months) of the tolerability and assessment of the efficacy of two devices containing hyaluronic acid intended for filling of lines and restoring volume to the face and lips.
Who can participate
Age range
19 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
. Adult subjects not under legal protection who have given their written agreement to take part.
. Men or women, 19 years old or older with no upper limit.
. Fitzpatrick phototype, I, II, III or IV.
. Middle 1/3 of the face (cheeks/cheek pads): Score 3 or 4 (moderate to substantial loss of volume in the middle 1/3 of the face) on Medicis Midface Volume Scale (MMVS) AND/OR Lips: Score of 1 to 2 (very thin to thin lips) on the Medicis Lip Fullness Scale (MLFS)
. Subjects seen at least 12 months after any aesthetic surgery procedure to the face.
. Subjects at least 12 months from any corrective aesthetic facial injection (botulin in toxin or any filling agent) in the study regions, i.e. 1/3 of the midface and peri-oral/lip region.
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.
. Subjects who are members of a social security system.
Exclusion criteria
. Subjects who do not meet the selection criteria.
. Subjects participating in any other clinical study on the assessment of medicinal products or medical devices or subjects who are in the exclusion period following a clinical study.
. Subjects who have received a facial injection/implantation of any non-resorbable filling agent.
. Subjects with skin support devices (tension wires, gold wires or weave) in their face.
. Subjects who have received laser or ultrasound medical treatment, deep chemical peeling or dermabrasion to the face during the previous 3 months or intending to undergo such a treatment to the face during the study.
. Subjects with a known past history of hypertrophic, cheloid or dyschromic scarring.
. Subjects with a past history of multiple severe allergies or anaphylactic shock.
. Subjects with known hypersensitivity to any of the components of the study devices.