AestheticNCT07079397
Hyaluronic Acid Filler Migration
A study testing Restylane Injectables in people with Aesthetic, run by Erevna Innovations Inc. at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aesthetic
- What is being tested?
- Restylane Injectables
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 11 Dec 2025to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
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- Participants must be willing and able to comply with procedures required in the protocol.
- Participants must be in good health as per investigator's judgment based on medical. history.
- 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
Who cannot join
- 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;
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- 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;
- Previous facial surgery, including liposuction;
- Lifetime history of permanent implants in the treatment region;
- 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;
- 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;
- Participant has an uncontrolled systemic diseases
- 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
- 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;
- Scars, deformities, piercing, or tattoos in the treatment areas;
- Facial cancer or precancer (e.g., actinic keratosis);
- History of radiation therapy to the treatment area;
- 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;
- Participants with active immune disorders such as systemic lupus erythematosus, rheumatoid arthritis, mixed connective tissue disease, and Hashimoto's thyroiditis, or participants using immunosuppressants;
- Participants with a tendency to form hypertrophic or keloid scars, or any other healing disorders;
- Participants with known hypersensitivity to lidocaine or agents structurally related to amide type local anaesthetics (e.g., certain anti-arrhythmics);
- Participants administered dental block or topical administration of lidocaine within 2 weeks of treatment;
- Participants with epilepsy, impaired cardiac conduction, severely impaired hepatic function or severe renal dysfunction;
- Current remote infections (e.g., urinary tract, sinuses, intestinal tract, oral cavity);
- Planned dental procedures during the 2-week period before and after filler treatments, including teeth cleaning, tooth extraction and gum grafts.
- Planned COVID-19 vaccinations during the 2-week period before and after filler treatments.
- History of cystic acne (for those that will be treated in the chin region).
- 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
- Anticipated need for surgery or hospitalization during the course of the study
- 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.
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Conditions
- Aesthetic
- Being tested
- Restylane Injectables
- Keywords
- Hyaluronic Acid, Fillers, Facial Assessment, Migraion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restylane InjectablesDevice
Participants will receive pan-facial treatment in at least one facial area using a Restylane NASHA product and at least one different facial area using Restylane OBT product. Participants will undergo three (3) scheduled MRI scans thoughout the duration of the study post HA injections.
| Study group | Role | What they receive |
|---|---|---|
| Restylane Injectables | Other | All adult participants (>18 years) Receives: Device: Restylane Injectables |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
High resolution MRI will determine presence of filler migration. Migration will be assessed radiologically and defined as the presence of identifiable product in anatomical regions outside the treatment area (where the product was initially placed) using a dichotomous qualitative response "yes/no".
Measured: Baseline (post optimal correction), Week 12 and Week 24
Secondary outcomes (2)
Number of particpants assessed as having proudct distribution past the area of injection. Assesment will be determined clincially by a qualified physician.
Physician evaluation will determine the distribution/integration patterns of NASHA and OBT-based fillers through palpable assessment in whcih the physician will use a binary "yes" or "no" responde to denote filler migration from the area of original placemement.
Measured: Baseline (post optimal correction), Week 12 and Week 24
Number of particpants assessed as having proudct distribution past the area of injection. Assesment will be made uisng ultrasoundimaging
Ultrasound evaluation will determine the distribution/integration patterns of NASHA and OBT-based fillers through visual changes to position of filler deposition.
Measured: Baseline (post optimal correction), Week 12 and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start11 Dec 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AestheticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erevna Innovations Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreas Nikolis, MD, Principal investigator, Erevan Innovations Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07079397
- Sponsor's protocol ID
- GAL-2025-MIG-67
- Status last verified
- Jan 2026
- First submitted
- 29 May 2025
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07079397
- Acronym / sponsor ID
- GAL-2025-MIG-67
- Conditions
- Aesthetic
- Keywords
- Hyaluronic Acid, Fillers, Facial Assessment, Migraion
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Erevna Innovations Inc.University, hospital or other
- Study start
- 11 Dec 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 23 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Restylane Injectables | Other | Device: Restylane InjectablesAll adult participants (>18 years) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (40 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Restylane InjectablesParticipants will receive pan-facial treatment in at least one facial area using a Restylane NASHA product and at least one different facial area using Restylane OBT product. Participants will undergo three (3) scheduled MRI scans thoughout the duration of the study post HA injections. | Device | Restylane Injectables |
Primary outcome
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.
Time frame: Baseline (post optimal correction), Week 12 and Week 24
High resolution MRI will determine presence of filler migration. Migration will be assessed radiologically and defined as the presence of identifiable product in anatomical regions outside the treatment area (where the product was initially placed) using a dichotomous qualitative response "yes/no".
2 secondary outcomes
Number of particpants assessed as having proudct distribution past the area of injection. Assesment will be determined clincially by a qualified physician.
Time frame: Baseline (post optimal correction), Week 12 and Week 24
Number of particpants assessed as having proudct distribution past the area of injection. Assesment will be made uisng ultrasoundimaging
Time frame: Baseline (post optimal correction), Week 12 and Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Nikolis, MD principal investigator
Erevan Innovations Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restylane Injectables in people with Aesthetic, run by Erevna Innovations Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Baseline (post optimal correction), Week 12 and Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.