Pan-facial multilayering with hyaluronic acid fillers

A Prospective Clinical Trial Evaluating the Safety and Efficacy of Concurrently Layering Hyaluronic Acid Fillers in Different Tissue Planes During Facial Aesthetic Treatments

This study will test whether a pan‑facial, multilayering approach using Restylane hyaluronic acid fillers can improve facial volume and contours for adults seeking aesthetic enhancement.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Erevna Innovations Inc. (Academic / other)
• Locations: 1 site (Montreal, Quebec)
• Trial ID: NCT07063511 on ClinicalTrials.gov

What this trial studies

Investigators will use a pan‑facial multilayering injection technique with Restylane hyaluronic acid products to tailor volume and contour across multiple facial layers based on individual anatomy. Participants will receive injections from trained injectors using a planned multilayer approach, with follow-up visits to document aesthetic outcomes and monitor safety. The protocol emphasizes personalized treatment selection among different HA formulations and attention to underlying laxity and hollowness. Safety monitoring will exclude participants with conditions that increase risk for adverse events and will record any local or systemic reactions.

Who should consider this trial

Good fit: Adults age 18 or older in generally good health who want facial aesthetic improvement and have no contraindications to hyaluronic acid fillers are the intended participants.

Not a fit: People with contraindications such as uncontrolled systemic disease, neuromuscular disorders, facial nerve palsy, active facial infection, or known severe reactions to HA, as well as those with unrealistic expectations, may not benefit from participation.

Why it matters

Potential benefit: If successful, this approach could give patients more natural, personalized facial rejuvenation with potentially longer‑lasting or more harmonious results.

How similar studies have performed: Hyaluronic acid fillers are widely used and have a strong safety and effectiveness record, and multilayering/pan‑facial injection techniques are practiced clinically, though formal controlled trial data on this specific pan‑facial multilayering methodology are limited.

Eligibility criteria

Inclusion Criteria:

1. 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.
2. Participants must be adult male or female, at least 18 years old.
3. Participants must be willing and able to comply with procedures required in the protocol.
4. Participants must be in good health as per investigator's judgment based on medical history.
5. Participants must not have uncontrolled systemic disease.
6. 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:

   * 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
7. 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.
8. 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).
9. Participants must not have tattoos, jewellery, or clothing which obscure the treatment area and cannot be removed.
10. Participants do not have anticipated need for surgery or overnight hospitalization during the study.
11. 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).
12. 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.
13. Participant has not received treatment with energy-based devices in the last 6 months.
14. Participant has not received soft tissue filler within the last 12 month in the face.
15. Female participants of child-bearing potential must have a negative urine pregnancy test prior to any dose of study drug.
16. 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.
17. 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.
18. 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
19. Participants must not be presenting with porphyria.
20. Participants must not present with active disease, such as inflammation, infection or tumours, cold sores in or near the intended treatment sites.
21. Participants must not have bleeding disorders or take thrombolytics or anticoagulants.
22. Participants agree to abstain from taking any over the counter NSAIDs at least two weeks prior to any treatment administration (e.g. Advil)
23. Participants must not have need to take immunosuppressants.

Exclusion Criteria:

1. Participants with known active COVID infection within 14 days of baseline treatment.
2. Participants has a history of cystic acne.
3. 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.

Where this trial is running

Montreal, Quebec

• Erevna Innovations Inc. — Montreal, Quebec, Canada (Recruiting)

Study contacts

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

Conditions Aesthetic; Hyaluronic Acid; Fillers; Facial Assessment; Multilayering Treatment