Pan-Facial Layering of Hyaluronic Acid Filler

NCT07063511 | Recruiting

• 1 other identifier: GAL-2025-LAYER-62
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Aesthetic

Keywords

Hyaluronic Acid; Fillers; Facial Assessment; Multilayering Treatment

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline to Week 24

Study Arms (1)

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.

Device: Restylane Injectables

Interventions

Restylane Injectables DEVICE

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.

Restylane Injectables

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erevna Innovations Inc.: lead

Study Sites (1)

Erevna Innovations Inc.

Montreal, Quebec, H3Z 1C3, Canada

RECRUITING

Study Officials

• Andreas Nikolis, MD

  Erevan Innovations Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Raco

CONTACT

514-488-0163 Ext. 246; lraco@vicpark.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: July 14, 2025
• Study Start: July 2, 2025
• Primary Completion (Estimated): July 2, 2026
• Study Completion (Estimated): August 2, 2026
• Last Updated: September 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)