AestheticNCT07063511
Pan-Facial Layering of Hyaluronic Acid Filler
A study testing Restylane Injectables in people with Aesthetic, run by Erevna Innovations Inc. at 1 site in Canada.
Trial summary
Recent advancements in anatomical studies have enabled a more sophisticated approach to treating patients with facial aesthetic concerns with hyaluronic acid (HA) fillers. For instance, volumizing a specific area of concern may be warranted, but it is essential to understand how the underlying patient anatomy is… 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
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 2 Jul 2025to 22 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Participants must voluntarily sign and date an informed consent, approved by an independent ethics committee, prior to the initiation of any screening or study-specific procedures.
- Participants must be adult male or female, at least 18 years old.
- 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.
- Participants must not have uncontrolled systemic disease.
- Participants do not 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:
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- 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
- Participants do not have history of clinically significant medical conditions or any other reason that the investigator determines would interfere with the participants participation in this study or would make the participant an unsuitable candidate to receive the study medical device.
- Participants do not have history of an allergic reaction or significant sensitivity to constituents of the study medical device (or its excipients), including local anaesthetic agents found in the product (Lidocaine).
- Participants must not have tattoos, jewellery, or clothing which obscure the treatment area and cannot be removed.
- Participants do not have anticipated need for surgery or overnight hospitalization during the study.
- Participants do not have history of surgical procedures in the face, including any lifting procedure (e.g., facial lift, suture lift, thread lift, brow lift, eyelid and/or eyebrow surgery).
- Participants have not had, in the last 2 years, facial treatment with semi- permanent or permanent soft tissue fillers (e.g., poly-L-lactic acid, polyalkylimide, polymethylmethacrylate, polytetrafluoroethylene, and silicone), synthetic implantation and/or autologous fat transplantation.
- Participant has not received treatment with energy-based devices in the last 6 months.
- Participant has not received soft tissue filler within the last 12 month in the face.
- Female participants of child-bearing potential must have a negative urine pregnancy test prior to any dose of study drug.
- Female participants of childbearing potential must 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.
- Female participants that are not pregnant or breastfeeding and are not 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.
- Participants must not have been treated with any investigational product within 30 days prior to the first dose of study medical device or is currently enrolled in another clinical study
- Participants must not be presenting with porphyria.
- Participants must not present with active disease, such as inflammation, infection or tumours, cold sores in or near the intended treatment sites.
- Participants must not have bleeding disorders or take thrombolytics or anticoagulants.
- Participants agree to abstain from taking any over the counter NSAIDs at least two weeks prior to any treatment administration (e.g. Advil)
- Participants must not have need to take immunosuppressants.
Who cannot join
- Participants with known active COVID infection within 14 days of baseline treatment.
- Participants has a history of cystic acne.
- Participant has had or is planning to have dental procedures, including teeth cleaning procedures at least 2 weeks before or after any scheduled treatment administration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Clinical Trial Evaluating the Safety and Efficacy of Concurrently Layering Hyaluronic Acid Fillers in Different Tissue Planes During Facial Aesthetic Treatments
Recent advancements in anatomical studies have enabled a more sophisticated approach to treating patients with facial aesthetic concerns with hyaluronic acid (HA) fillers. For instance, volumizing a specific area of concern may be warranted, but it is essential to understand how the underlying patient anatomy is continuing to laxity and hollowness.
Varying manufacturing technology have offered a range of HA fillers with different physical and chemical properties adapted to different indications, each one tailored to provide a slightly different outcome based on the needs of the patient.
Read more
Given these advances in the medical aesthetic field, investigators and clinicians are seeking to develop a new methodology for providing patients with a more tailored and personalized treatment approach. This methodology includes using a pan-facial, multilayering treatment technique that can be employed by injectors once experience is gained with standard techniques.
The goal of this study is to assess the efficacy and safety of layering HA from the Restylane line of soft tissue products to create a more harmonious and complete aesthetics results.
- Conditions
- Aesthetic
- Being tested
- Restylane Injectables
- Keywords
- Hyaluronic Acid, Fillers, Facial Assessment, Multilayering Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restylane InjectablesDevice
Participants will receive multilayering treatment (i.e., one product will be placed deep and one in a more superficial plane) in area of primary deficit (i.e., the midface or lower face), in isolation or combination with other treatment areas.
| Study group | Role | What they receive |
|---|---|---|
| Restylane Injectables | Other | Thirty (30) adult (> 18 years) participants, including fifteen (15) participants with a primary deficit of the midface, and fifteen (15) participants with a primary deficit of the lower face (chin, lips) as assessed by the Treating Investigator. Primary deficit is defined as facial third requiring more intense treatment or volumes of HA. Receives: Device: Restylane Injectables |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and severity of adverse events (AEs) related to multilayering treatment technique
Safety of multilayering treatment technique will be determined by the frequency and severity of adverse events (AEs): a. physician-reported and b. participant-reported.
Measured: Baseline to Week 24
Evaluate the efficacy of concurrently layering hyaluronic acid fillers in different tissue planes during facial aesthetic treatments in the same region at different depths
The efficacy of multilayering treatment technique will be determined by the frequency of participants having at least "improved" (e.g., "improved", "much improved" or "very much improved") on the Global Aesthetics Improvement Scale (GAIS), a 5-point scale, categorized as "worse", "no change", "improved", "much improved", and "very much improved", as graded by a blinded evaluator.
Measured: Baseline to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start2 Jul 2025
- Primary completion22 May 2026
- Study completion22 Jun 2026
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
- 30 participants (actual)
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
- NCT07063511
- Sponsor's protocol ID
- GAL-2025-LAYER-62
- Status last verified
- Jul 2025
- First submitted
- 3 Jul 2025
- Last updated
- 11 Sep 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 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Trial Evaluating the Safety and Efficacy of Concurrently Layering Hyaluronic Acid Fillers in Different Tissue Planes During Facial Aesthetic Treatments
- ClinicalTrials.gov ID
- NCT07063511
- Acronym / sponsor ID
- GAL-2025-LAYER-62
- Conditions
- Aesthetic
- Keywords
- Hyaluronic Acid, Fillers, Facial Assessment, Multilayering Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Erevna Innovations Inc.University, hospital or other
- Study start
- 2 Jul 2025 (actual)
- Primary completion
- 22 May 2026 (actual)
- Study completion
- 22 Jun 2026 (actual)
- First posted
- 14 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.
Recent advancements in anatomical studies have enabled a more sophisticated approach to treating patients with facial aesthetic concerns with hyaluronic acid (HA) fillers. For instance, volumizing a specific area of concern may be warranted, but it is essential to understand how the underlying patient anatomy is continuing to laxity and hollowness.
Varying manufacturing technology have offered a range of HA fillers with different physical and chemical properties adapted to different indications, each one tailored to provide a slightly different outcome based on the needs of the patient.
Given these advances in the medical aesthetic field, investigators and clinicians are seeking to develop a new methodology for providing patients with a more tailored and personalized treatment approach. This methodology includes using a pan-facial, multilayering treatment technique that can be employed by injectors once experience is gained with standard techniques.
The goal of this study is to assess the efficacy and safety of layering HA from the Restylane line of soft tissue products to create a more harmonious and complete aesthetics results.
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 InjectablesThirty (30) adult (> 18 years) participants, including fifteen (15) participants with a primary deficit of the midface, and fifteen (15) participants with a primary deficit of the lower face (chin, lips) as assessed by the Treating Investigator. Primary deficit is defined as facial third requiring more intense treatment or volumes of HA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Participants must voluntarily sign and date an informed consent, approved by an independent ethics committee, prior to the initiation of any screening or study-specific procedures.
- Participants must be adult male or female, at least 18 years old.
- 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.
- Participants must not have uncontrolled systemic disease.
Key exclusion criteria (3 listed)
- Participants with known active COVID infection within 14 days of baseline treatment.
- Participants has a history of cystic acne.
- Participant has had or is planning to have dental procedures, including teeth cleaning procedures at least 2 weeks before or after any scheduled treatment administration.
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 multilayering treatment (i.e., one product will be placed deep and one in a more superficial plane) in area of primary deficit (i.e., the midface or lower face), in isolation or combination with other treatment areas. | Device | Restylane Injectables |
Primary outcome
Frequency and severity of adverse events (AEs) related to multilayering treatment technique
Time frame: Baseline to Week 24
Safety of multilayering treatment technique will be determined by the frequency and severity of adverse events (AEs): a. physician-reported and b. participant-reported.
Evaluate the efficacy of concurrently layering hyaluronic acid fillers in different tissue planes during facial aesthetic treatments in the same region at different depths
Time frame: Baseline to Week 24
The efficacy of multilayering treatment technique will be determined by the frequency of participants having at least "improved" (e.g., "improved", "much improved" or "very much improved") on the Global Aesthetics Improvement Scale (GAIS), a 5-point scale, categorized as "worse", "no change", "improved", "much improved", and "very much improved", as graded by a blinded evaluator.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 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 27 inclusion and 3 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: finished, as of the sponsor's last update on 11 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Frequency and severity of adverse events (AEs) related to multilayering treatment technique (time frame: Baseline to Week 24). The study lists 2 primary outcomes in all. 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 11 Sep 2026.