Soft tissue filler injections continue to grow in popularity as a method of facial rejuvenation, including volume restoration and contour enhancement.
Many different hyaluronic acid (HA)-based fillers are available on the market and differ in terms of their physical and chemical properties, which results in families of fillers (e.g., Non-Animal Stabilized Hyaluronic Acid - NASHA vs. Optimal Balance Technology - OBT) with different tissue integration patterns. It has been proposed that the properties of fillers significantly influences their tendency to migrate. More specifically, thick fillers may be less prone to migration compared to fluid fillers. However, a detailed knowledge of facial anatomy, safer injection techniques, and careful product selection based on filler qualities may be preventive measures for filler migration.
The goal of this study is to describe the short and intermediate-term product distribution/integration patterns of NASHA and OBT-based fillers, and to evaluate the evidence (if any) of filler migration from the intended site of injection.
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
. At the time of consent, male or female participants 18 years of age and older;
. Participants with established facial volume loss and/or contour deficits;
. Accepted the obligation not to receive any other facial procedures throughout the study duration;
. Understood and accepted the obligation and would be logistically able to appear for all scheduled follow-up visits;
. No previous facial fillers for 18 months prior to this study;
. Capable of providing informed consent, approved by an independent ethics committee, prior to the initiation of any screening or study-specific procedures;
. Participants must be willing and able to comply with procedures required in the protocol.
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
Evaluate evidence (if any) of filler migration from the intended site of injection for NASHA and OBT-based fillers, as visualized by high resolution MRI.
Timeframe: Baseline (post optimal correction), Week 12 and Week 24
. Participants must be in good health as per investigator's judgment based on medical. history.
Exclusion criteria
. Current Pregnancy or lactation \[sexually active women of childbearing age must agree to use medically acceptable methods of contraception for the duration of this study (e.g., oral contraceptives, condoms, intrauterine device, shot/injection, patch)\];
. Hypersensitivity to Restylane products, HA filler or amide local anesthetics;
. Participants presenting with porphyria or any other liver diseases;
. Inability to comply with follow-up and abstain from facial injections during the study period;
. Heavy smokers, classified as smoking more than 12 cigarettes per day;
. History of severe or multiple allergies manifested by anaphylaxis, since drug allergies might preclude optimal management of complications;
. Previous tissue revitalization therapy in the treatment area within 6 months before treatment with laser or light, mesotherapy, radiofrequency, ultrasound, cryotherapy, chemical peeling, or dermabrasion;