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MRI reveals whether popular wrinkle fillers migrate after injection

NCT ID NCT07079397

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study uses MRI scans to see if two types of hyaluronic acid fillers (NASHA and OBT) move from where they are injected in the face. Ten adults with facial volume loss will get fillers in different areas and have three MRI scans over time. The goal is to understand how the fillers integrate and whether they migrate, which could help improve injection safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Restylane injectables (hyaluronic acid fillers)
What this could lead to
If successful, this could help doctors choose fillers that are less likely to move from the injection site, improving safety and results.
What could go wrong
This is a very small study (10 people) with no control group, so findings may not apply to everyone. It only looks at short-term migration, not long-term safety.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. At the time of consent, male or female participants 18 years of age and older; 2. Participants with established facial volume loss and/or contour deficits; 3. Accepted the obligation not to receive any other facial procedures throughout the study duration; 4. Understood and accepted the obligation and would be logistically able to appear for all scheduled follow-up visits; 5. No previous facial fillers for 18 months prior to this study; 6. Capable of providing informed consent, approved by an independent ethics committee, prior to the initiation of any screening or study-specific procedures; 7. Participants must be willing and able to comply with procedures required in the protocol. 8. Participants must be in good health as per investigator's judgment based on medical. history. 9. Female participants of childbearing potential must be willing practice at least 1 protocol-specified method of birth control that is effective from Baseline through at least 30 days after the last dose or until the end of study, whichever is longer. Female participants of non-childbearing potential do not need to use birth control Exclusion Criteria: 1. Current Pregnancy or lactation \[sexually active women of childbearing age must agree to use medically acceptable methods of contraception for the duration of this study (e.g., oral contraceptives, condoms, intrauterine device, shot/injection, patch)\]; 2. Hypersensitivity to Restylane products, HA filler or amide local anesthetics; 3. Participants presenting with porphyria or any other liver diseases; 4. Inability to comply with follow-up and abstain from facial injections during the study period; 5. Heavy smokers, classified as smoking more than 12 cigarettes per day; 6. History of severe or multiple allergies manifested by anaphylaxis, since drug allergies might preclude optimal management of complications; 7. 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; 8. Previous facial surgery, including liposuction; 9. Lifetime history of permanent implants in the treatment region; 10. History in the last 18 months of semi-permanent dermal fillers (e.g., poly-L-lactic acid, polyalkylimide, polymethylmethacrylate, polytetrafluoroethylene, and silicone), synthetic implantation and/or autologous fat transplantation in the treatment region; 11. History or presence of any disease or lesion near or at the treatment area, including inflammation, active or chronic infection, including in the mouth, dentals, head and neck region; 12. Participant has an uncontrolled systemic diseases 13. Participants present with or have a history of any medical condition that may place the participant at increased risk following exposure to hyaluronic acid or interfere with the study evaluation, including: * Diagnosed myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function * History of facial nerve palsy * Infection or dermatological condition at the treatment injection sites * Marked facial dermatochalasis, deep dermal scarring, excessively thick sebaceous skin, or excessively photodamaged skin 14. Facial psoriasis, eczema, acne, rosacea, perioral dermatitis, herpes zoster or any other facial condition that may increase the risk of cutaneous penetration of infective agents; 15. Scars, deformities, piercing, or tattoos in the treatment areas; 16. Facial cancer or precancer (e.g., actinic keratosis); 17. History of radiation therapy to the treatment area; 18. History of bleeding disorders, or treatment with thrombolytics, anticoagulants, or inhibitors of platelet aggregation (e.g., Aspirin or other non-steroid anti-inflammatory drugs \[NSAIDs\]), within 2 weeks before treatment; 19. Participants with active immune disorders such as systemic lupus erythematosus, rheumatoid arthritis, mixed connective tissue disease, and Hashimoto's thyroiditis, or participants using immunosuppressants; 20. Participants with a tendency to form hypertrophic or keloid scars, or any other healing disorders; 21. Participants with known hypersensitivity to lidocaine or agents structurally related to amide type local anaesthetics (e.g., certain anti-arrhythmics); 22. Participants administered dental block or topical administration of lidocaine within 2 weeks of treatment; 23. Participants with epilepsy, impaired cardiac conduction, severely impaired hepatic function or severe renal dysfunction; 24. Current remote infections (e.g., urinary tract, sinuses, intestinal tract, oral cavity); 25. Planned dental procedures during the 2-week period before and after filler treatments, including teeth cleaning, tooth extraction and gum grafts. 26. Planned COVID-19 vaccinations during the 2-week period before and after filler treatments. 27. History of cystic acne (for those that will be treated in the chin region). 28. Female participants that is pregnant or breastfeeding and is considering becoming pregnant or donating eggs during the study or for approximately 30 days after the last dose of study medical device or until the end of study, whichever is longer 29. Anticipated need for surgery or hospitalization during the course of the study 30. History of other treatment/procedure that, in the treating investigator's opinion, would interfere with the study injections and/or study assessments or exposes the participant to undue risk by study participation. 31. Contraindications for Magnetic Resonance Imaging (MRI) such as: * Implanted pacemakers or defibrillators * Metallic implants of any kind including cochlear implants and orthodontics * Claustrophobia * Pregnancy * Loud noises

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Erevna Innovations Inc.

    Westmount, Quebec, H3Z 1C3, Canada

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