How hyaluronic acid fillers move after facial injections

The Integration Pattern of Non-Animal Stabilized Hyaluronic Acid (NASHA)- and Optimum Balance Technology (OBT)-Based Fillers: An Ultrasound and Magnetic Resonance Imaging (MRI) Study

This will see if two types of hyaluronic acid fillers (NASHA and OBT) move or integrate differently in adults getting facial volume-restoring injections.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Erevna Innovations Inc. (other)
• Drugs / interventions: radiation
• Locations: 1 site (Westmount, Quebec)
• Trial ID: NCT07079397 on ClinicalTrials.gov

What this trial studies

This interventional study compares short- and intermediate-term tissue distribution and integration patterns of NASHA and OBT family hyaluronic acid fillers after facial injection. Participants with facial volume loss receive injections (including Restylane, a NASHA filler) and are followed through scheduled clinical visits to document product location and behavior. The protocol restricts recent fillers and other facial procedures to reduce confounding and requires participants to attend multiple follow-up visits. Results will link filler properties and injection practices to observed migration or integration patterns.

Who should consider this trial

Good fit: Adults aged 18 or older with established facial volume loss or contour deficits who have not had facial fillers in the prior 18 months and who can attend all scheduled visits and avoid other facial procedures during the study.

Not a fit: People who had recent facial fillers (within 18 months), cannot attend follow-up visits, are pregnant or breastfeeding, or plan other facial procedures during the study are unlikely to benefit.

Why it matters

Potential benefit: If successful, the results could help clinicians choose fillers and techniques that reduce unwanted migration and improve cosmetic outcomes.

How similar studies have performed: Case reports and small observational studies have suggested differences in filler spread related to product rheology, but direct head-to-head clinical comparisons are limited.

Eligibility criteria

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

Where this trial is running

Westmount, Quebec

• Erevna Innovations Inc. — Westmount, Quebec, Canada (RECRUITING)

Study contacts

• Principal investigator: Andreas Nikolis, MD — Erevan Innovations Inc.
• Study coordinator: Laura Raco

Conditions: Aesthetic, Hyaluronic Acid, Fillers, Facial Assessment, Migraion