Clinical Performance and Safety of STYLAGE® HydroMax (NCT07153237) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Clinical Performance and Safety of STYLAGE® HydroMax
France81 participantsStarted 2025-09-09
Plain-language summary
FHAME is a post-market clinical investigation designed to strengthen the clinical evidence supporting the effectiveness of STYLAGE® HydroMax in the treatment of superficial wrinkles, primarily on the cheeks.
Who can participate
Age range
35 Years – 70 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
. Subjects without any pathology aged between 35 and 70 years old at inclusion.
. Subjects wishing treatment for the aesthetic improvement of facial wrinkles.
. Subject having given freely and expressly their informed consent.
. Subject with a Grade 2 to 5 score on the Bazin cheek wrinkle scale.
. Subject with the same wrinkle score according to the Bazin cheek wrinkle scale for both cheeks (i.e., symmetrical cheeks).
. Subject psychologically able to understand investigation related information and to give written informed consent.
. Subject affiliated to a health social security system.
. Female of childbearing potential must use a medically accepted contraceptive regimen for at least 12 weeks prior to the start of the investigation and for the duration of the investigation.
Exclusion criteria
. Pregnant or breastfeeding woman or woman planning a pregnancy during the investigation.
. Woman less than a year past menopause.
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
Mean changes in cheek wrinkle score (independant blinded evaluator)
. Subject with a tattoo, a scar, moles, too many hairs or body hairs (i.e. beard), or anything on the studied zones which might interfere with outcome evaluations.
. Subject who has been deprived of their freedom by administrative or legal decision or who is under guardianship.
. Member of the investigating team or family member of a member of the investigating team.
. Subject in a social or sanitary establishment.
. Subject having received 6000 euros indemnities for participation in research involving human beings in the 12 previous months, including participation in the present investigation.
. Subject participating in another research on human beings or who is in an exclusion period of one.