Clinical Evaluation of the Safety and Performance of a Filler in Correction of Mid-face Age-relat… (NCT04505319) | Clinical Trial Compass
CompletedNot Applicable
Clinical Evaluation of the Safety and Performance of a Filler in Correction of Mid-face Age-related Volume Deficit
France50 participantsStarted 2020-09-14
Plain-language summary
Prospective, single center study, on healthy subjects to evaluate the aesthetic improvement of facial volume, effect on the restoration and/or augmentation in subjects with mid-face age-related volume deficit after injection of a filler with lidocaine.
Who can participate
Age range
40 Years – 60 Years
Sex
FEMALE
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
. Healthy subject;
. Sex: female;
. Age: between 40 and 60 years;
. BMI between 18 and 25 included.
. Subject having given freely and expressly his informed consent;
. Subject with a volume deficit on malar area and requiring a correction using a filler;
. Subject, psychologically able to understand the study related information and to give a written informed consent;
. Subject affiliated to a health social security system;
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
Global aesthetic improvement one month
Timeframe: one month after injection (first visit from Day 0)
. Pregnant or nursing woman or planning a pregnancy during the study.
. 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.
. Subject participating to another research on human beings or being in an exclusion period for a previous study.
. Subject having received 4500 euros indemnities for participation in researches involving human beings in the 12 previous months, including participation in the present study.
. Intensive exposure to sunlight or UV-rays within the previous month and foreseen during the study.
. Subject with a tattoo, a scar, moles, pigment disorders or anything on the studied zones which may interfere with the study at the investigator appreciation.
. Subject with unstable weight or planning to do a dietary regime during the study.